Effect of breastfeeding education and support provided to the male partner on optimal breastfeeding practice in southern Ethiopia: Study protocol of a cluster- randomized controlled trial

Effect of breastfeeding education and support provided to the male partner on optimal breastfeeding practice in southern Ethiopia: Study protocol of a cluster- randomized controlled trial | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Study protocol Effect of breastfeeding education and support provided to the male partner on optimal breastfeeding practice in southern Ethiopia: Study protocol of a cluster- randomized controlled trial Mulatu Abageda, Tefera Belachew This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-3284805/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background: Optimal breastfeeding is essential for the survival, growth, and development of children, as well as the health of mothers. Globally, optimal breastfeeding practices are still low: only 42% of newborns start breastfeeding within the first hour of birth, 41% of infants less than 6 months of age are exclusively breastfed, and only 45% of mother’s breastfeed for at least two years. Every year, it is estimated that optimal breastfeeding practices might avoid 823,000 child deaths. However, breastfeeding practices are not optimal in Ethiopia. Male partners play a vital but frequently neglected role in the promotion of breastfeeding practices, and they are not included in the breastfeeding education. The effect of interventions to promote breastfeeding that specifically target male partners on optimal breastfeeding practices has not been investigated in the Ethiopian context. Methods: A parallel cluster-randomized controlled trial will be conducted to evaluate the effect of breastfeeding education and support provided to male partners on optimal breastfeeding practice compared to routine care at the community level. Trained healthcare professionals chosen from the closest health center to the intervention cluster will provide the intervention to the mothers and male partners. The mothers and male partners in the Intervention Group (IG) will receive both antenatal and postnatal breastfeeding education and support starting from their 3 rd trimester of pregnancy till 6 month post-delivery, but those in the Control Group (CG) will receive routine care. The breastfeeding education and support intervention is comprised of four components: 1) Antenatal BF education on their 3 rd trimester of pregnancy, 2) providing specific take-home print materials, 3) Individual home visit . A total of 408 couples with pregnancies in the third trimester from 16 clusters (Kebeles) will be randomly assigned to the intervention group (204) or the control group (204). Epi-data version 3.1 will be used to enter data, and STATA version 14.0 will be used to analyze it. The analysis will be done by intention to treat approach. Generalized Estimating Equation (GEE) model will be used to determine the effect of the intervention on optimal breastfeeding practice. P values < 0.05 will be used to declare statistical significance. Discussion: The results of the trial will provide evidence of the effectiveness of male partner-focused breastfeeding education and support interventions on optimal breastfeeding practices in community settings in Ethiopia. The study's findings will help policymakers and practitioners understand how to best involve male partners and establish their contributions to breastfeeding best practices. Trial registration: ClinicalTrials.gov identifier (NCT number): NCT05173454, May 20, 2022. Cluster randomised trial optimal breastfeeding practice male partner education and support Ethiopia Figures Figure 1 Background Optimal breast feeding is the initiation of breastfeeding within the first hour of birth, exclusive breastfeeding for the first six months, and continued breastfeeding for two years and beyond. These are optimal practices based on scientific evidence of their impact on health. Among the most successful strategies for enhancing child health are optimal feeding practices for infants and young children (1). Worldwide, breastfeeding rates fall well short of what is necessary to safeguard both women's and children's health. In the first hour following delivery, less than half (42%) of babies begin breastfeeding. The global target of 70% set for 2030 is substantially below the current rate of 41% of infants under 6 months who are exclusively breastfed. By the time a child is two years old, breastfeeding rates have fallen to 45%, even though more than two-thirds of mothers continue to do so for at least one year (2). Contrary to the WHO recommendation only 59% of infants under age 6 months are exclusively breastfed in Ethiopia, 14% of infants 0-5 months also consume plain water, 1% of them consume non-milk liquids, 8% consume other milk, and 13% consume complementary foods in addition to breast milk and 9% of infants under 6 months use a bottle with a nipple, a practice that is discouraged because of the risk of exposing the child to illness. The percentage of newborns who are exclusively breastfed drops dramatically with age, from 73% of those who are 0-1 months to 68% of those who are 2-3 months, and then to 40% of those who are 4-5 months. Continuing to breastfeed until age 2 is currently decreases from 85% among children age 12-17 months to 76% among children age 18-23 months (3). The WHO has underlined that more scientific evidences are needed across different regions, countries, population groups and contexts, in order to adequately and protect, encourage, and advocate for breastfeeding in a sensitive manner (4). Breastfeeding promotion requires multiple supportive measures that are executed through a variety of channels. One target for improving breastfeeding has been identified as male partners (5). Male partners’ attitude and support affect breastfeeding outcomes. However, they are not currently targeted in breastfeeding support and care provided by health care professionals (6). In the promotion of optimal breastfeeding practices, male partners play a crucial but frequently underappreciated role (7). Many qualitative studies show that male partner desire to be involved with breastfeeding and encourage their partners. However many feel left out and helpless; felt they lack the knowledge, understanding, and skill to do this; and called for more education and support to be directed towards them, rather than their partner alone (5, 8, 9). In 20 low- and middle-income countries, 28 initiatives were reviewed descriptively from 2003 to 2013. Male involvement strategies varied widely in various project areas. Increases in EBF proportions did not consistently correlate with the degree or nature of male partner participation. Understanding how gender norms may influence male involvement in women's health practices is lacking. Specifically, more studies about the effect of male partner engagement on breastfeeding practices are required, including formative research about male involvement in decisions regarding infant feeding and women’s desire for male partner involvement in breastfeeding promotion and support (10). The involvement of family in education, counseling, and information efforts about the benefits and management of breastfeeding is also understudied (4). Programs intended to encourage male partner participation in breastfeeding support through educational interventions have primarily been adopted in industrialized nations (11, 12). In low- and middle-income countries (LMIC), breastfeeding interventions aimed at male partners increase the rate of early breastfeeding initiation and exclusive breastfeeding, and continued breastfeeding. But breastfeeding interventions focusing on male partners from LMIC are limited (13). In Ethiopia, a few behaviour change interventions aimed at improving optimal breastfeeding practices have been conducted by the different scholars (14-16). However, none of the interventions targeted male partners to promote and support optimal breastfeeding practices during pregnancy as well as the postnatal period. Most pictures on breastfeeding show mothers and babies but not men. Putting all of the attention on the dyad isn't going to get the outcomes we need to make breastfeeding the cultural norm in baby feeding. The breastfeeding dyad should be expanded to a breastfeeding triad to acknowledge the significance of the male partner in supporting breastfeeding attempts and the influence that the informal support system can have on breastfeeding promotion (17-19). Therefore, the aim of this study is to assess a community-based educational intervention program in South Ethiopia that targets male partners during pregnancy and the postnatal period in order to encourage their involvement and determine their support for effective breastfeeding practices. Study objectives/hypotheses Research Hypothesis : Mothers whose partners received the breastfeeding education and support intervention have increased optimal breastfeeding practices than mothers whose male partner did not receive the intervention. Primary objective - To evaluate the effect of breastfeeding education and support provided for a male partner on optimal breastfeeding practice. Secondary objectives – the secondary objectives are: To examine the effect of breastfeeding education and support intervention on male partners’ knowledge, attitude, and supportive practice on optimal breastfeeding practices. To measure the role of breastfeeding education and support provided to male partner on mother's breastfeeding self-efficacy. To compare the effect of breastfeeding education and support provided to male partner with routine care on the frequency of child morbidity. To compare breastfeeding education and support provided to male partner with routine care on maternal perceptions on male partners' breastfeeding support. To explore men’s and women’s experiences of male partner supportive practices to optimal breastfeeding practice. Methods/design Design The intervention trial will use a parallel single-blind, two-arm, 1:1 allocation ratio cluster-randomized controlled trial design and will be conducted and reported in line with the CONSORT recommendations for cluster-randomized trials (1). The trial is to investigate the effectiveness of a breastfeeding education and support intervention provided to male partners on optimal breastfeeding practices in Soro and Gibe districts, Hadiya zone, Southern Ethiopia. The intervention will be delivered in community settings, and this study design was chosen in order to avoid contamination among treatment groups. Kebeles found in the selected districts will form the unit of randomization for the trial, and kebeles will be randomly assigned to either the intervention or control study groups. The intervention duration will be 9 months. Participants will be recruited starting in their third trimester of pregnancy until six months post-delivery. Setting The study will take place in the Hadiya Zone, which is one of the Southern Nations Nationalities and Peoples’ Regional State’s administrative zones in South Ethiopia. Hosanna is the capital of the Hadiya Zone, which is located 232 kilometres south of Addis Ababa. Hadiya Zone has 13 districts and four town administration. In the Zone, there are 1,727,920 people in total, 846,681 men, and 881,239 women, according to the CSA's estimated 2007 Census. Hadiya Zone has a population density of 342.64 people per square kilometre, covering 3,593.31 square kilometres. The trial will be conducted in the Gibe and Soro districts, which are two of the 13 districts found in the Hadiya zone. Gibe and Soro districts will be selected purposefully. The total population size of the two districts (Soro and Gibe) is 333,117, out of which 11,526 are estimated to be pregnant mothers. The two districts (Soro and Gibe) will be selected with a total of 54 Kebeles (the lowest administrative unit). In the two districts, there are 65 health institutions, including 55 health posts, 8 health centres, and two primary hospitals (one in Gibe and one in Soro district). Eligibility criteria for participants Inclusion criteria Male partner and mother being in the third trimester of pregnancy Male partner and healthy mother with no underlying disease. Male partner and healthy mother with no pregnancy complication. Male partner who live with their wives at home or maintain regular communication with them. Partners capable of giving informed consent Partners living in the selected cluster with no plans to move away during the intervention period Exclusion criteria Mother who experienced a pregnancy loss (miscarriage, still birth, neonatal death) during the follow up period Mother had serious medical problems Couples who divorced or separated or migrated out of the study area during the intervention Twin gestation (known twin gestation will be excluded) Infants admitted to neonatal ICUs at birth Sample size determination The sample size (n) required for the study will be calculated with G*Power to estimate a two population proportion by considering the following assumptions. At baseline, 45.5 % of mothers use optimal breastfeeding practice at six months (20), and we are looking to see an improvement of 20% optimal breastfeeding practice by education and support intervention at six months in the intervention group. A type I error of 5% Strength of 80% with 95% CIs A total of 170 father/mother pairs in each group will be needed. As this is a randomized design with clusters (each cluster is a kebeles), the sample size needs to be increased taking into account the effect of the design. Considering a design effect of 2 and a loss of follow-up of 20%, the total sample size will be 408 father/ mother pairs ( 204 in intervention and 204 in control groups). By assuming an intra-cluster correlation coefficient of 0·1 for a cluster size of 26, it will be calculated that we will need 16 clusters (Kebeles). In the two selected districts (Gibe and Soro) of Hadiya Zone, there are about 55 Kebeles, which is the lowest administrative unit in Ethiopia. The 16 clusters (Kebeles) will be selected which is 30% of the total Kebeles in Gibe and Soro districts (8 intervention arms and 8 control arms). Sampling and randomization procedures From the 13 districts in Hadiya Zone, two districts will be selected purposively. After identifying and listing the 55 Kebeles found in the selected districts or woredas, 16 non adjacent Kebeles will be selected. Then eligible pregnant women will be identified from the selected Kebeles using the health extension worker’s logbook before the Kebeles are randomized into either the intervention or control groups. Kebeles found in the selected districts will form the unit of randomization for the trial, while father-mother pairs within the Kebeles will form units of observation or analysis. To create comparable groups and remove the source of selection bias in the assignment of Kebeles to the intervention and control groups, the randomization will be carried out by an independent biostatistician (someone not participating in the study). Allocation concealment will be done for clusters, as they will not know if they will be in the intervention group or not. First cluster ID will be given like #1, #2, #3…#16 then names of the sequentially numbered clusters with the given ID will be closed in an opaque envelope and a blinded randomizer (biostatistician) will produce comparable groups. Simple randomization with a 1:1 allocation will be used to randomize Kebeles to either the control or intervention groups. First, 16 nonadjacent clusters will be selected purposively from Kebeles in two selected districts (Gibe and Soro) in the Hadiya Zone. Then, the 16 clusters (Kebeles) will be listed alphabetically by their name and closed in an opaque envelope with their ID. A list of random numbers will be generated in MS Excel 2010, and the generated values will be fixed by copying them as ‘values’ next to the alphabetic list of the clusters. These will be arranged in ascending order according to the generated random number. Finally, the first eight clusters (Kebeles) will be selected as intervention clusters and the last eight as control clusters. Then, a simple random sampling technique will be performed to select mother-father pairs from each arm. We will select an equal number of participants from each cluster. The same sample of mother-father pairs will be used at the end of the intervention phase, nine months later, to measure the outcome variables ( Figure 1 ). Single-blinding will be applied, in which the outcome assessor (data collector) will be aware of the intervention allotted. Data collectors will be masked from the Kebeles allocation by not informing them of the allocation. Recruitment Hadiya Zone is one of the Southern Nations, Nationalities, and People Regional State of Ethiopia, which has 13 districts and four town administrations. According to different studies, the Southern Nations, Nationalities, and Peoples Regional State of Ethiopia is known for sub-optimal breastfeeding practices, which attracted the attention of the researchers to conduct this trial (21-24). Firstly, two (Soro and Gibe) districts will be identified from the Hadiya zones for this study. Then, sixteen geographically non-adjacent clusters, or Kebeles, will be identified from the existing Kebeles within the two study districts. The eligible pregnant women and their male partners will be identified from the selected Kebeles using the health extension worker’s logbook before the Kebeles are randomized into either the intervention or control group using simple randomization techniques, but recruitment will be started after clusters have been randomized. A sampling frame is then created. A simple random sampling technique is then used to select study participants from each cluster in each arm. The same number of participants is selected from each cluster. All non-adjacent kebele will be considered for the study, but only those that are sufficiently far from one another and have at least one kebele between clusters included for our trial that might act as a buffer area between them will be chosen. Informed consent will be obtained from each woman and her male partner prior to their inclusion in the trial. Those women and their male partners who consent to participate in the study will be included and requested to sign an informed consent to ensure voluntary participation. Once consent is obtained, each participant will be interviewed to complete a baseline survey in the third trimester of pregnancy. Similarly, end-line survey will be conducted after six months of post-delivery. Selection and training of research team The research team will be composed of: Breastfeeding educators or counselors : eight trained health care workers will be selected from the nearest health center to the intervention cluster (Kebeles). Criteria for selection will be: Good command of Amharic and Hadiyisa (the local language). Good interpersonal and communication skills. Staff in the respective cluster and stay for an entire research period. The educators or counselors will be trained for three days by the researcher. The training will cover paternal support and raised awareness about the components and importance of optimal breastfeeding practices. Communication and counseling skills will also be covered. A pre-test and post-test on breastfeeding knowledge will be administered to the educators or counselors before and after the training to ensure uniformity; all the educators or counselors should have to pass the test. Enumerators or outcome assessors: Data will be collected by 16 data collectors. The enumerators or data collectors will be trained for three days by the researcher. The training content included the study objectives, responsibilities of the data collectors, research instruments, and interview skills. Practical demonstrations will be conducted to ensure that the enumerators or data collectors understand the questions and learn the appropriate interviewing skills. The Intervention The intervention will be carried out continuously during both antenatal and postnatal periods from October 2022 to the end of August 2023. The intervention will be designed based on social cognitive theory (25). BF education and support intervention will be provided by trained health care workers selected from the nearest health center starting from the 3 rd trimester of pregnancy for both the male partner and mother, besides the routine information and education they get from health institutions as routine care. The intervention is composed of the following elements: i) antenatal and postnatal breastfeeding education to raise knowledge, awareness, support, and counseling on the benefits of optimal breastfeeding practices and involvement in supporting breastfeeding mothers; ii) Specific take-home print materials to be shared by both partners that support optimal breastfeeding practices; and iii) Individual home visits. Paternal and maternal group education will be given at their third trimester pregnancy for both the male partner and mother by preparing a small social event for 3 hours on the following topics: early BF initiation, importance of colostrum, BF on-demand and frequent feeds, benefits of EBF for infant and mother, positioning and attachment techniques during BF, dangers of pre-lacteal feeds, adequacy of breast milk for 6 months, dangers of breast milk substitutes, maternal diet and rest, continuing breastfeeding during sickness, and starting complementary feeding by the age of six months. The components of optimal breastfeeding practice messages delivered during group education for both partners are displayed in Table 1. Table 1: Components of messages for promoting optimal breastfeeding practices for male partners and mothers 1 Learn to recognise basic information on the benefits of breastfeeding for the baby, mother, family, and communities. 2 Put your baby on the breast immediately after birth, to stimulate your production of milk. 3 Feed your baby the first yellow milk (colostrum) helps to protect the infant from illness. 4 Feed your baby only breast milk for the first six months, not even giving water, for the baby to grow healthy and strong. 5 Breastfeed your baby on demand, at least 10 times day and night, to produce enough milk and provide your baby enough food to grow healthy. 6 Start giving complementary foods such as soft porridge 2-3 times a day for your baby when child completes 6 months in addition to breast milk to grow healthy and strong. 7 Continue to breastfeed your baby until two years and beyond to make it stay strong 8 Ensure breastfeeding women need to eat 2 extra meals a day to maintain her health and the health of the baby. 9 Continue breastfeeding your baby when either you or the infant is sick 10 Avoid pre-lacteal feeds such as sugar water, water, butter, are not necessary and may interfere with establishing good breastfeeding practices during the first days of the baby’s life. 11 12 Never use a bottle to feed your baby, as these are hard to keep clean and will cause diarrhea. Ensure correct positioning and attachment for optimal breastfeeding Specific take-home print materials will be given to both the male partner and the mother during the third trimester of pregnancy. One poster for the male partner and one template for the mother will be provided at the time of group education on the third trimester of pregnancy. The content of the poster for husbands includes continued paternal psychological, physical, and social support for breastfeeding mothers. The content of the template for mother includes optimal breastfeeding practices. The concept of take-home print materials will be explained during the offering for those who cannot read, and they will be advised to ask the help of a family member or neighbor who can read. Home visit: Individual counseling for male partners and mothers will be held at 6 weeks, 3.5 month and 5 months to remind the couples about optimal breastfeeding practices and male partners’ involvement in supporting breastfeeding mothers. Paternal supportive practices for breastfeeding mothers, such as household chores and responsibilities, caring for the baby, feeding the baby, caring for the mother, encouragement and motivation, being in agreement, and creating a favorable environment, will be delivered through take-home print materials and home visits in addition to optimal breastfeeding practice messages ( see table 2 ). Table 2 : Key messages for the male partner to support breastfeeding mothers. Help breastfeeding mother with: 1 Household chores and responsibilities such as cleaning, cooking, home maintenance, shopping, laundry and bill pay 2 Caring for the baby such as bathing, putting to sleep, changing diapers, playing and soothing 3 Feeding the baby such as swaddle baby after feeding, helps to burp baby after feeding, helps with positioning and latching 4 Caring for the mother such as allow mother time to sleep, rest, pump, break from baby, buy or prepare healthy foods to support or increase milk production 5 Offering word of encouragement and motivation such as ‘you can do it’, ‘keep going’, ‘I am proud of you’ and practical support with BF challenges 6 Being in agreement such as feel BF is joint responsibility, agrees on BF method and decision 7 Making favourable environment such as create stress free environment mothers to breastfeed, keeps things positively and has positive attitude on BF The Control Group (CG) will receive standard breastfeeding support (routine care), which will be given by health care professionals and HEW during antenatal or postnatal time. According to the Ethiopian Ministry of Health’s Health Extension Workers (HEW) program strategy, HEWs are female graduates with a certificate who are trained and deployed to work at the local health post at the kebele (lowest administrative unit in Ethiopia) level. HEW provides health-post-based IYCF counseling and education, including breastfeeding, to the mothers through the pregnant and lactating mother’s forum with the support of health care professionals from nearby health institutions (IYCF is one of the packages of health and nutrition interventions). In Ethiopia, HEW is focusing on the dyad (mother and child) alone in breastfeeding promotion, which is not producing the results needed to make breastfeeding optimal and the cultural norm in infant feeding. Expanding the "breastfeeding dyad" to a "breastfeeding triad" recognizes the importance of the male partner in supporting and strengthening breastfeeding efforts and the impact that the informal support structure can have in promoting breastfeeding. Therefore, in our trial design, Control Group (CG) mothers will receive breastfeeding counseling and education as routine care from HEW; this is considered an intervention provided to the mothers alone. This group received no intervention from the research team. Intervention groups (IG) will receive breastfeeding education and support for optimal breastfeeding practices. The intervention activities will be designed and implemented to target male partners and pregnant mothers starting in their third trimester. Male partners and women in the intervention group will receive enhanced breastfeeding education and support starting from their third trimester pregnancy until 6 months post-delivery. In the intervention group, fathers and mothers will receive breastfeeding counseling and education. The summary of the intervention protocol is displayed in Table 3. Table 3 : Summery of intervention protocol Content Dose Frequency Compliance parameters Responsible person 1 Paternal and maternal group education and counselling for fathers during last trimester • by preparing small social event 3 hours Once at their 3 rd trimester period -% male partners participated -% mothers participated researcher educators or counsellors 2 Providing specific take-home print materials Maternal OBF practices • paternal support practice -One poster for father and -one template for mother Once in the 3 rd trimester pregnancy -% of fathers received print materials -% mothers received print materials educators or counsellors 3 • Home visit • Individual counseling for male partners and mothers 20minutes Three time at • 6 th week • 3.5 month • 5 th month postpartum % father counselled % mother counselled educators or counsellors 4 End line data collection 30 at 6 th month of post-delivery % father interview % mother interview Data collectors. Variables Primary outcome variable Optimal breastfeeding practice Secondary outcome variables Paternal knowledge, attitude and supportive practices Breastfeeding Self-Efficacy Prevalence of child morbidity Maternal Perceptions on husbands’ breastfeeding support Data collection method Data will be collected with 16 data collectors through a face-to-face interview by trained nurses or midwives who are working in the nearest health center for a specific cluster and have not participated in the intervention. Baseline data will be collected from pregnant mothers and male partners in their 3 rd trimester. End-line data with all other outcome variables will be collected at the 6th month post-delivery. Basic socio-demographic and economic characteristics, maternal and pregnancy factors, and previous infant feeding experience of the partners will be collected at baseline. Data on knowledge, attitude, and involvement in supportive practice by the male partner, breastfeeding self-efficacy, and the perception of mothers on their husbands support will also be collected at the base line and end line. Data on new-borns, the maternity experience of the mother, and optimal breastfeeding practices will be collected at the end line, which is 6 months after delivery. The baseline and end-line questionnaires will include several previously validated and widely used instruments to measure factors associated with optimal breastfeeding outcomes. These will include the Iowa Infant Feeding Attitude Scale, the Breastfeeding Self-Efficacy Scale, and the Postpartum Partner Support Scale. Baseline data will be collected in the 3 rd trimester of pregnancy before the administration of the intervention. Study outcomes measures 1. Fathers’ breastfeeding knowledge will be assessed using a questionnaire adapted from the Food and Agricultural Organization (FAO) of the United Nations (UN) (26). This questionnaire has 16 questions, which will be coded into Yes or No responses, and one mark will be awarded for every correct response (yes), and zero will be awarded for every incorrect response (no). Hence, the total number of marks in the knowledge section ranged from 0 to 16. Male partners who score above the mean will be considered knowledgeable and those who score below the mean will be considered not knowledgeable. Breastfeeding attitudes will be measured using the Iowa Infant Feeding Attitude Scale (IIFAS). This tool has 17 questions and uses a 5 point Likert scale with options such as strongly agree to strongly disagree for each item. The total score will be calculated out of 85, with a minimum of 17 and a maximum of 85. This scale will help to identify the attitude of the male partner by capturing the favourable attitude (above the mean score) and unfavourable attitude (below the mean score) towards breastfeeding (27). The supportive practice of male partners in optimal breastfeeding practice will be measured by using a questionnaire adopted from the literature (28). This questionnaire has 8 questions, which will be coded into Yes or No responses, and one mark will be awarded for every correct response (yes), and zero will be awarded for every incorrect response (no). Hence, the total number of marks in the s upportive practice ranged from 0 to 8. Male partners’ who score above the mean will be considered to have supportive practice, and those who score below the means will be considered to a not s upportive practice. 2. In this study, mothers will be asked about infant breastfeeding practice, includes Early initiation of BF, breastfeeding frequently day and night (on demand), giving infants only breast milk for the first 6 months, the intended duration of breastfeeding, pre-lacteal feeding, and a history of feeding colostrum. Exclusive breastfeeding at 6 months is measured as the proportion of women who provided their infants with only breast milk but no solids, nonhuman milk, water, or other liquids (other than vitamins or medications) at 6 months. Exclusive breastfeeding practices will be identified using various methods including the last 24 hours, the last week, and since-birth recalls. The duration of exclusive breastfeeding will be identified by asking the mother to recall the time when she stopped EBF with the child. On-demand breastfeeding will be measured by asking mothers about breastfeeding frequency greater than or equal to 8 times per 24 hours. Pre-lacteal feeding will be measured by asking mothers whether they pre-lacteally feed their child within three days of delivery. Colostrum feeding will be measured by asking mothers about the history of feeding the first yellow milk to their child. The infant breastfeeding practice scores will be summed to give a total score that could range between 0 and 6. The infant breastfeeding practice scores will then be classified as Poor (0–2), Medium (3–4), or Good (5–6). When the study subjects have scored the highest tertile (good) of infant breastfeeding practice scores, they will be considered optimal breastfeeding practices, and the lowest two tertiles (poor and medium) of infant breastfeeding practice scores will be merged and will be considered sub-optimal breastfeeding practices. To reduce recall bias at 6 months, optimal breastfeeding practices (early initiation of breastfeeding, exclusive breastfeeding, and frequency of breastfeeding day and night (on demand)) will be measured in three ways: the last 24 hours recall, the last week's recall, and the since birth recall. The mother will be probed to recall her breastfeeding practices. The criteria for scoring breastfeeding practices are displayed in Table 4. Table 4 : The criteria for scoring optimal breastfeeding practices for infants-age 0–6 months Infant feeding components Response 1 Early initiation of BF 1 hours=0 2 breastfeeding frequently day and night (on demand) >8= 1 =2 years=1 <2years= 0 5 pre-lacteal feeding No=1 Yes= 0 6 feeding colostrum Yes=1 No=0 Range of total score 0-6 3. Breastfeeding Self-Efficacy (BSE) refers to a mother’s confidence in her ability to breastfeed her infant. Data on maternal BF self-efficacy will be collected at baseline and at the end line. The breastfeeding Self-Efficacy Scale-Short Form, developed to assess breastfeeding self-efficacy during the postnatal period, is a 14-item self-report instrument scored on a 5-point Likert-type scale where 1 = not at all confident and 5 = very confident. Items are presented positively and summed to produce a total score ranging from 14 to 70, with higher scores indicating higher levels of breastfeeding self-efficacy (29). 4. Morbidity status will be an outcome variable. Three morbidities will be used to determine a child's morbidity status: diarrhea, fever, and acute respiratory infections (ARIs). The following questions will be used to determine diarrhea and fever in this study: Has the child experienced diarrhea in the last two weeks? Secondly, has the child experienced any recent fever in the past two weeks? The women's answers to the following questions will be used to determine if they have acute respiratory illnesses: A) Has the child experienced a cough-accompanied illness within the previous two weeks? b) Did the child have difficulty breathing or breathe more quickly than normal when they had an illness with a cough? and c) was the fast or difficulty breathing brought on by a chest issue or a blocked or runny nose? The women's answers to the following questions will be used to determine if they have acute respiratory illnesses: A) Has the child experienced a cough-accompanied illness within the previous two weeks? b) Did the child have difficulty breathing or breathe more quickly than normal when they had an illness with a cough? and c) was the fast or difficulty breathing brought on by a chest issue or a blocked or runny nose? Children with at least one of the three morbidities during the intervention period will be considered to have a high frequency of morbidity; otherwise, there will be no morbidity in the child during the intervention period (30). 5. Husbands’ support for breastfeeding will be defined as the physical, emotional, and psychosocial support the mother receives from her husband during breastfeeding. Physical support refers to helping during positioning the mother for breastfeeding, helping in breastfeeding at night, helping in child care activities and household work, and seeking service from a healthcare provider for breastfeeding problems. Emotional and psychosocial support refers to encouraging women verbally to breastfeed, encouraging them to breastfeed in public areas, and involving them in the decision-making process to breastfeed. Maternal perceptions of husbands’ breastfeeding support will be measured by the postpartum partner support scale, a 25-item self-report instrument designed to assess partner postpartum perceptions of support. Items are rated on a 4-point scale to produce a summative score ranging from 25 to 100, with higher scores indicating higher levels of maternal perceptions of postpartum-specific partner support (6). Outcomes will be assessed as illustrated in the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) ( see table 5). Table 5: Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Outcomes Allocation Study period Enrolment Close-out -t1 Baseline (t0) Intervention from 3 rd trimester to 6 th month after delivery End line at month 6 after delivery (t1) 1 Enrolment Allocation x Eligibility screen x Informed consent x 2 Interventions x 3 Socio-demographics of both partner x x 4 Base line male partners’ knowledge, attitude and supportive practice on optimal breastfeeding x 5 Change in male partners’ knowledge, attitude and supportive practice on optimal breastfeeding x x 6 Optimal breastfeeding practices x 7 Mother's BF self-efficacy x x 8 Frequency of child morbidity x 9 Maternal perception on husbands support x x Data management and analysis The data will be entered into a computer using Epi Data 3.1 and analyzed using STATA Window version 14.0. All statistical significance will be declared at a P-value less than 0.05. The analysis will be done using an intention to treat approach. The baseline characteristics will be compared using the chi-square test for categorical variables and the independent t-test for continuous variables. A paired t-test will be used to analyze the difference between the mean of paternal knowledge and attitude, self-efficacy scores, and maternal perception on husband support scale scores in the intervention group before and after intervention and the difference in the mean in the control group before and after intervention. Pearson’s correlation will be used to determine if there will be a relationship between maternal perception on the husband support scale and breastfeeding self-efficacy and optimal breastfeeding. The Poisson regression analysis will be applied to examine the effect of the intervention on childhood morbidity compared to control. Logistic regression analysis will be used to determine the significance of the association between paternal knowledge and attitude as independent variables. Linear regression will be used to see the association between maternal perceptions on the husband support scale as continuous outcome variable and other covariates. Finally, a Generalized Estimating Equations (GEE) model that controls for within-Kebele clustering will be used to estimate the effect of the intervention on optimal breastfeeding practice and breastfeeding self-efficacy scores at 6 months post-delivery. In all analyses, the adjustment will be made for clustering at the Kebele level since randomization was done at the cluster level rather than the individual level. The audio-recorded data during the FGD and in-depth interview will be first transcribed in the local language (Hadiyisa) immediately after completion, translated into English, and then imported into Atlas Ti7 software for thematic analysis. Credibility will be ensured by peer debriefing, prolonged engagement, clarifying researcher bias, quotes in the manuscript, and member checking. Dependability will be ensured by a rich description of the research methods, ensuring and measuring coding accuracy and intercoders’ reliability. Conformability will be ensured by reflexivity and triangulation (methodological, data source, investigators, and theoretical). Transferability will be ensured by purposeful sampling, data saturation, and comparing results. Data quality control The data collectors will be recruited and trained for two days. Questionnaires will be prepared first in English by the investigator and then translated to Amharic (the working language) by another individual who is native to Amharic (the working language). The questionnaire will be translated back into English by another individual to maintain its consistency. Questionnaires will be developed utilizing questions previously validated in the other study. The FAO and IIFAS questionnaires have been field-tested in several countries to ensure validity, readability, ease of administration, and less burdensomeness on respondents. Thus, the questionnaire formulated based on the FAO, BSE, and IIFAS questionnaires will be pre-tested on 5% of mother-male partner pairs for the purpose of precision, validity, and ease of data collection. All tools will be pre-tested in one Kebele not included in the study to make necessary amendments to the tools. The baseline and follow-up questionnaires will include many previously validated and widely used instruments to measure optimal breastfeeding practices. The selected and trained supervisors will supervise the data collector on a daily basis for completeness and consistency of the tool. Additionally, prior to the analysis, the data will be meticulously cleansed and fed into the computer. Dissemination plan The findings of this trial will be presented to the Southern Nations, Nationalities, and Peoples Regional State of Ethiopia and relevant stakeholders in the local community. Papers from this trial will be published in peer-reviewed journals and communicated to the scientific community. Moreover, findings will be presented at national and international conferences and workshops. Discussion The aim of the trial is to evaluate a community-based educational intervention targeting male partners at both antenatal and postnatal periods for supporting optimal breastfeeding practices by considering Ethiopians socio-economic and cultural context during the design and implementation of the intervention. At the start of the trial, counseling through phone contactswas included as part of an intervention package. However, when recruitment was started, we cancelled counseling through phone contacts from the intervention package due to the poor phone penetration rate in the study area, and even some of the participants have no phone, which may introduce an uncontrollable bias. Intervention implementers will not be part of the team collecting outcome data. This trial is designed to assess outcomes within the common intervention duration of 9 months Several studies have examined the effectiveness of breastfeeding education and support interventions that target male partners (31-34). However, interventions delivered through a community-based approach that targets male partners to improve optimal breastfeeding practices in mothers in LMICs have not been sufficiently investigated. Results of the trial will provide evidence of the effectiveness of male partner-focused breastfeeding education and support interventions on optimal breastfeeding practices in community settings in South Ethiopia. The study findings will inform policymakers and practitioners on targeting male partners to stimulate their engagement and establish male partner contributions to supporting optimal breastfeeding practices. Trial status All trial participants have been recruited from the selected clusters, and baseline data have been collected. Training of intervention implementers (health care workers from the nearest health institution) in the intervention arm is completed, and specific take-home print materials (a poster and template) are prepared for both the mother and male partner in Amharic. Abbreviations BF: Breastfeeding; BSE: Breastfeeding Self-Efficacy; CG: Control Group; CI: Confidence Interval; EBF: Exclusive Breastfeeding; FGD: Focus Group Discussion; GEE: Generalized Estimating Equation; HEW: Health Extension Worker; IG: Intervention Group; IIFAS: Iowa Infant Feeding Attitude Scale; IYCF: Infant and Young Child Feeding; LMIC: Low- and Middle-Income Countries; WHO: World Health Organization Declarations Competing interests The authors declare that they have no competing interests. Authors’ contributions MA and TB wrote the first draft, participated in the trial design, and reviewed subsequent drafts leading to the final manuscript. MA wrote the original draft. MA and TB reviewed the final draft of the protocol. Both authors read and approved the final protocol. Acknowledgements We would like to acknowledge the support provided by the Nestlé Foundation for the study of problems of nutrition in the world, Lausanne, Switzerland. The trial team wishes to acknowledge Jimma University and Wachemo University for their grant and ethical approval. Funding This cluster randomised trial is supported by a grant from the Nestlé Foundation for the study of problems of nutrition in the world, Lausanne, Switzerland and Jimma University. The study sponsor and funder have no role in the design of the study and collection, analysis, and interpretation of data, and the writing of the manuscript. Ethics approval and consent to participate The protocol was reviewed and approved by Jimma University Institutional review board (JUIRB) (reference number JUIRB37/22) and Wachemo University Research Ethics Committee (WCUREC) (reference number WCU.RE.Dev.Di/010/2015). The investigator will duly inform the subjects that participate in the study and will request their informed consent, signed and dated in writing. He or she will provide complete and adequate verbal and written information about the nature, purpose, and possible risks and benefits of the study. The purpose of the study will be explained to the study subjects. At the time of data collection, verbal consent will be taken from the participants to confirm whether they are willing to participate. Those not willing to participate will be given the right to do so. The confidentiality of responses will also be ensured throughout the research process. Written permission will be asked for audio recording of the conversation during FGDs and KIIs. The respondents will be informed that their identity and the evidence they provide will be kept private. The willingness of participants will be asked for the home visit for the issue of privacy. COVID-19 infection prevention precautions will be strictly applied to study participants, educators, and data collectors. A face mask and sanitizer will be provided for data collectors and educators to use during the data collection and intervention periods. Standard physical distancing between study participants, educators, and data collectors to prevent COVID-19 will be applied throughout the study period. Availability of data and materials Data sharing is not applicable to this protocol as no datasets are generated or analysed yet. Consent for publication Not applicable References WHO. Infant and young child feeding: model chapter for textbooks for medical students and allied health professionals 2009. UNICEF W. Global Breastfeeding Collective. Global Breastfeeding Scorecard, 2017: Enabling women to breastfeed through better policies and programmes. . New York, Geneva 2018. Agency CS. Ethiopian Demographic and health survey 2019, Ethiopia ORC Macro Calverton Maryland, USA July 2019; 2019. WHO. Guideline: protecting, promoting and supporting breastfeeding in facilities providing maternity and newborn services. Geneva:: World Health Organization; 2017. p. Licence: CC BY-NC-SA 3.0 IGO. Brown A, Davies R. Fathers' experiences of supporting breastfeeding: challenges for breastfeeding promotion and education. Matern Child Nutr. 2014;10(4):510-26. Abbass-Dick J, Stern SB, Nelson LE, Watson W, Dennis CL. Coparenting breastfeeding support and exclusive breastfeeding: a randomized controlled trial. Pediatrics. 2015;135(1):102-10. Bich TH, Hoa DT, Ha NT, Vui le T, Nghia DT, Malqvist M. Father's involvement and its effect on early breastfeeding practices in Viet Nam. Matern Child Nutr. 2016;12(4):768-77. Merritt R, Vogel M, Ladbury P, Johnson S. A qualitative study to explore fathers' attitudes towards breastfeeding in South West England. Primary health care research & development. 2019;20:e24. Tohotoa J, Maycock B, Hauck YL, Howat P, Burns S, Binns CW. Dads make a difference: an exploratory study of paternal support for breastfeeding in Perth, Western Australia. International breastfeeding journal. 2009;4:15. Yourkavitch JM, Alvey JL, Prosnitz DM, Thomas JC. Engaging men to promote and support exclusive breastfeeding: a descriptive review of 28 projects in 20 low- and middle-income countries from 2003 to 2013. Journal of Health, Population and Nutrition. 2017;36(1). Cohen R, Lange L, Slusser W. A description of a male-focused breastfeeding promotion corporate lactation program. Journal of human lactation : official journal of International Lactation Consultant Association. 2002;18(1):61-5. Tohotoa J, Maycock B, Hauck Y, Howat P, Burns S, Binns C. Supporting mothers to breastfeed: the development and process evaluation of a father inclusive perinatal education support program in Perth, Western Australia. Health Promot Int. 2011;26(3):351-61. Tadesse K, Zelenko O, Mulugeta A, Gallegos D. Effectiveness of breastfeeding interventions delivered to fathers in low- and middle-income countries: A systematic review. Matern Child Nutr. 2018;14(4):e12612. Abdulahi M, Fretheim A, Magnus JH. Effect of breastfeeding education and support intervention (BFESI) versus routine care on timely initiation and exclusive breastfeeding in Southwest Ethiopia: study protocol for a cluster randomized controlled trial. BMC Pediatrics. 2018;18(1). Belay S, Haidar J. Effect of prenatal education on breastfeeding initiation and exclusive breast feeding rate in selected health institutions of Hawassa city, the capital of SNNPR , Ethiopia. East African journal of public health. 2013;10:622-31. Admasu J, Egata G, Bassore DG, Feleke FW. Effect of maternal nutrition education on early initiation and exclusive breast-feeding practices in south Ethiopia: a cluster randomised control trial. Journal of nutritional science. 2022;11:e37. Goodman JH. Becoming an Involved Father of an Infant. Journal of Obstetric, Gynecologic & Neonatal Nursing. 2005;34(2):190-200. Mitchell-Box K, Braun KL. Fathers' thoughts on breastfeeding and implications for a theory-based intervention. Journal of obstetric, gynecologic, and neonatal nursing : JOGNN. 2012;41(6):E41-50. de Montigny F, Lacharité C. Fathers’ Perceptions of the Immediate Postpartal Period. Journal of Obstetric, Gynecologic & Neonatal Nursing. 2004;33(3):328-39. Hagos A. Individual and community-level factors influencing optimal breastfeeding: A multilevel analysis from a national survey study in Ethiopia. 2016. Dessalegn Tamiru¹ , M. Sc, Binyam Bogale², MPH, Behailu Merdikios³, MGH. Breastfeeding patterns and factors associated with exposure to Sub-optimal breastfeeding practices in rural communities of Arba Minch Zuria, Ethiopia. Global Health Perspectives ·. 2013;01(02). Abageda M, Mokonen A, Hamdela B. Predictors of Optimal Breastfeeding Practices Among Mothers Who Have Less Than 24 Months of Age Children in Misha District, Hadiya Zone, South Ethiopia. J Preg Child Health. 2015;2:182. Awoke N, Tekalign T, Lemma T. Predictors of optimal breastfeeding practices in Worabe town, Silte zone, South Ethiopia. PloS one. 2020;15(4):e0232316. Shibru Hoche BM, Negash Wakgari. Sub-Optimal Breast Feeding and Its Associated Factors in Rural Communities of Hula District, Southern Ethiopia: A Cross-Sectional Study. Ethiop J Health Sci. 2017;28(1):49. Bandura A. Health promotion from the perspective of social cognitive theory. Psychology and health. 1998;13(4):623-49. Marías YFaPG. Guidelines for assessing nutrition-related knowledge, attitudes and practices. Rome: Food and Agriculture Organization of the United Nations (FAO); 2014. p. vi + 180 pp. de la Mora A, Russell D, Dungy C, Losch M, Dusdieker L. The Iowa Infant Feeding Attitude Scale: Analysis of Reliability and Validity1. Journal of Applied Social Psychology - J APPL SOC PSYCHOL. 1999;29:2362-80. Dinga LA K-MB, Kyallo F. fathertargeted-nutrition-education-improves-early-initiation-and-breastfeeding-exclusivity-the-case-of-kisumu-county-kenya.pdf. J Food Sci Nutr. 2018;1(3):12-7. Dennis CL. The breastfeeding self-efficacy scale: psychometric assessment of the short form. Journal of obstetric, gynecologic, and neonatal nursing : JOGNN. 2003;32(6):734-44. Nigatu D, Azage M, Motbainor A. Effect of exclusive breastfeeding cessation time on childhood morbidity and adverse nutritional outcomes in Ethiopia: Analysis of the demographic and health surveys. PloS one. 2019;14(10):e0223379. Ozluses E, Celebioglu A. Educating fathers to improve breastfeeding rates and paternal-infant attachment. Indian pediatrics. 2014;51(8):654-7. Pisacane A, Continisio GI, Aldinucci M, D'Amora S, Continisio P. A controlled trial of the father's role in breastfeeding promotion. Pediatrics. 2005;116(4):e494-8. Su M, Ouyang YQ. Father's Role in Breastfeeding Promotion: Lessons from a Quasi-Experimental Trial in China. Breastfeeding medicine : the official journal of the Academy of Breastfeeding Medicine. 2016;11:144-9. Susin LR, Giugliani ER. Inclusion of fathers in an intervention to promote breastfeeding: impact on breastfeeding rates. Journal of human lactation : official journal of International Lactation Consultant Association. 2008;24(4):386-92; quiz 451-3. Additional Declarations No competing interests reported. Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-3284805","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Study protocol","associatedPublications":[],"authors":[{"id":539812768,"identity":"8e5d9c91-caac-4efe-80d3-a9373e0dd3ee","order_by":0,"name":"Mulatu Abageda","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA0ElEQVRIiWNgGAWjYFAC5gYQwcAPYicUEKWFEaJFEkQlGJCixeAAiEOMFt0ZiY0Pv1RYyxufX5344YEBgzy/2AH8WsxuJDYby5xJN9x24+1mCaDDDGfOTiCopU1asu0w47YbZzeAtCQY3Caspf235L/D9ptnnN38g1gtbYwfGw4nbuDv3UakLWceNkszHEtPnnGDd5tFgoEEEX45nnzw448aa9v+/rObb/6osJHnlyagBQSYeUCkBFilBGHlIMD4A0TyHyBO9SgYBaNgFIw8AADTnUqKEH3lGAAAAABJRU5ErkJggg==","orcid":"","institution":"Wachemo University","correspondingAuthor":true,"prefix":"","firstName":"Mulatu","middleName":"","lastName":"Abageda","suffix":""},{"id":539812769,"identity":"20261700-dffa-4a7c-b15b-ab87568d3a2b","order_by":1,"name":"Tefera Belachew","email":"","orcid":"","institution":"Jimma University","correspondingAuthor":false,"prefix":"","firstName":"Tefera","middleName":"","lastName":"Belachew","suffix":""}],"badges":[],"createdAt":"2023-08-22 07:44:27","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-3284805/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-3284805/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":95173474,"identity":"a208a027-361e-45c7-aafc-ac5f673758c5","added_by":"auto","created_at":"2025-11-05 06:43:45","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":45498,"visible":true,"origin":"","legend":"\u003cp\u003eFlowchart of participants\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-3284805/v1/e0bd8cda0de4866773409d6a.png"},{"id":95227942,"identity":"67e13227-1421-4e58-b988-0ccb937b4e11","added_by":"auto","created_at":"2025-11-05 16:33:12","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1173463,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-3284805/v1/ba9db554-5aed-4327-8c09-cd589c307b7f.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Effect of breastfeeding education and support provided to the male partner on optimal breastfeeding practice in southern Ethiopia: Study protocol of a cluster- randomized controlled trial","fulltext":[{"header":"Background","content":"\u003cp\u003eOptimal breast feeding is the initiation of breastfeeding within the first hour of birth, exclusive breastfeeding for the first six months, and continued breastfeeding for two years and beyond. These are optimal practices based on scientific evidence of their impact on health. Among the most successful strategies for enhancing child health are optimal feeding practices for infants and young children (1).\u003c/p\u003e\n\u003cp\u003eWorldwide, breastfeeding rates fall well short of what is necessary to safeguard both women's and children's health. In the first hour following delivery, less than half (42%) of babies begin breastfeeding. The global target of 70% set for 2030 is substantially below the current rate of 41% of infants under 6 months who are exclusively breastfed. By the time a child is two years old, breastfeeding rates have fallen to 45%, even though more than two-thirds of mothers continue to do so for at least one year (2).\u003c/p\u003e\n\u003cp\u003eContrary to the WHO recommendation only 59% of infants under age 6 months are exclusively breastfed in Ethiopia, 14% of infants 0-5 months also consume plain water, 1% of them consume non-milk liquids, 8% consume other milk, and 13% consume complementary foods in addition to breast milk and 9% of infants under 6 months use a bottle with a nipple, a practice that is discouraged because of the risk of exposing the child to illness. The percentage of newborns who are exclusively breastfed drops dramatically with age, from 73% of those who are 0-1 months to 68% of those who are 2-3 months, and then to 40% of those who are 4-5 months. Continuing to breastfeed until age 2 is currently decreases from 85% among children age 12-17 months to 76% among children age 18-23 months (3).\u003c/p\u003e\n\u003cp\u003eThe WHO has underlined that more scientific evidences are needed across different regions, countries, population groups and contexts, in order to adequately and protect, encourage, and advocate for breastfeeding in a sensitive manner (4). Breastfeeding promotion requires multiple supportive measures that are executed through a variety of channels. One target for improving breastfeeding has been identified as male partners (5).\u003c/p\u003e\n\u003cp\u003eMale partners\u0026rsquo; attitude and support affect breastfeeding outcomes. However, they are not currently targeted in breastfeeding support and care provided by health care professionals (6). In the promotion of optimal breastfeeding practices, male partners play a crucial but frequently underappreciated role (7).\u003c/p\u003e\n\u003cp\u003eMany qualitative studies show that male partner desire to be involved with breastfeeding and encourage their partners. However many feel left out and helpless; felt they lack the knowledge, understanding, and skill to do this; and called for more education and support to be directed towards them, rather than their partner alone (5, 8, 9).\u003c/p\u003e\n\u003cp\u003eIn 20 low- and middle-income countries, 28 initiatives were reviewed descriptively from 2003 to 2013. Male involvement strategies varied widely in various project areas. Increases in EBF proportions did not consistently correlate with the degree or nature of male partner participation. Understanding how gender norms may influence male involvement in women's health practices is lacking. Specifically, more studies about the effect of male partner engagement on breastfeeding practices are required, including formative research about male involvement in decisions regarding infant feeding and women\u0026rsquo;s desire for male partner involvement in breastfeeding promotion and support (10).\u003c/p\u003e\n\u003cp\u003eThe involvement of family in education, counseling, and information efforts about the benefits and management of breastfeeding is also understudied (4). Programs intended to encourage male partner participation in breastfeeding support through educational interventions have primarily been adopted in industrialized nations (11, 12). In low- and middle-income countries (LMIC), breastfeeding interventions aimed at male partners increase the rate of early breastfeeding initiation and exclusive breastfeeding, and continued breastfeeding. But breastfeeding interventions focusing on male partners from LMIC are limited (13).\u003c/p\u003e\n\u003cp\u003eIn Ethiopia, a few behaviour change interventions aimed at improving optimal breastfeeding practices have been conducted by the different scholars (14-16). However, none of the interventions targeted male partners to promote and support optimal breastfeeding practices during pregnancy as well as the postnatal period.\u003c/p\u003e\n\u003cp\u003eMost pictures on breastfeeding show mothers and babies but not men. Putting all of the attention on the dyad isn't going to get the outcomes we need to make breastfeeding the cultural norm in baby feeding. The breastfeeding dyad should be expanded to a breastfeeding triad to acknowledge the significance of the male partner in supporting breastfeeding attempts and the influence that the informal support system can have on breastfeeding promotion (17-19). Therefore, the aim of this study is to assess a community-based educational intervention program in South Ethiopia that targets male partners during pregnancy and the postnatal period in order to encourage their involvement and determine their support for effective breastfeeding practices.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eStudy objectives/hypotheses\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eResearch Hypothesis\u003c/em\u003e: Mothers whose partners received the breastfeeding education and support intervention have increased optimal breastfeeding practices than mothers whose male partner did not receive the intervention.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003ePrimary objective\u003c/em\u003e\u003c/strong\u003e - To evaluate the effect of breastfeeding education and support provided for a male partner on optimal breastfeeding practice.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eSecondary objectives\u003c/em\u003e\u003c/strong\u003e \u0026ndash; the secondary objectives are:\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003eTo examine the effect of breastfeeding education and support intervention on male partners\u0026rsquo; knowledge, attitude, and \u003cstrong\u003esupportive practice\u003c/strong\u003e on optimal breastfeeding practices.\u003c/li\u003e\n\u003cli\u003eTo measure the role of breastfeeding education and support provided to male partner on mother's breastfeeding self-efficacy.\u003c/li\u003e\n\u003cli\u003eTo compare the effect of breastfeeding education and support provided to male partner with routine care on the frequency of child morbidity.\u003c/li\u003e\n\u003cli\u003eTo compare breastfeeding education and support provided to male partner with routine care on maternal perceptions on male partners' breastfeeding support.\u003c/li\u003e\n\u003cli\u003eTo explore men\u0026rsquo;s and women\u0026rsquo;s experiences of male partner supportive practices to optimal breastfeeding practice.\u003c/li\u003e\n\u003c/ul\u003e"},{"header":"Methods/design","content":"\u003cp\u003e\u003cstrong\u003eDesign\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe intervention trial will use a parallel single-blind, two-arm, 1:1 allocation ratio cluster-randomized controlled trial design and will be conducted and reported in line with the CONSORT recommendations for cluster-randomized trials (1). The trial is to investigate the effectiveness of a breastfeeding education and support intervention provided to male partners on optimal breastfeeding practices in Soro and Gibe districts, Hadiya zone, Southern Ethiopia. The intervention will be delivered in community settings, and this study design was chosen in order to avoid contamination among treatment groups. Kebeles found in the selected districts will form the unit of randomization for the trial, and kebeles will be randomly assigned to either the intervention or control study groups. The intervention duration will be 9 months. Participants will be recruited starting in their third trimester of pregnancy until six months post-delivery.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSetting\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe study will take place in the Hadiya Zone, which is one of the Southern Nations Nationalities and Peoples\u0026rsquo; Regional State\u0026rsquo;s administrative zones in South Ethiopia. Hosanna is the capital of the Hadiya Zone, which is located 232 kilometres south of Addis Ababa. Hadiya Zone has 13 districts and four town administration. In the Zone, there are 1,727,920 people in total, 846,681 men, and 881,239 women, according to the CSA\u0026apos;s estimated 2007 Census. Hadiya Zone has a population density of 342.64 people per square kilometre, covering 3,593.31 square kilometres. The trial will be conducted in the Gibe and Soro districts, which are two of the 13 districts found in the Hadiya zone. Gibe and Soro districts will be selected purposefully.\u0026nbsp;The total population size of the\u0026nbsp;two districts (Soro and Gibe) is 333,117, out of which 11,526 are estimated to be pregnant mothers. The\u0026nbsp;two districts (Soro and Gibe) will be selected with a total of 54 Kebeles (the lowest administrative unit). In the two districts, there are 65 health institutions, including 55 health posts, 8 health centres, and two primary hospitals (one in Gibe and one in Soro district).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEligibility criteria for participants\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eInclusion criteria\u003c/strong\u003e\u003c/p\u003e\n\u003cul\u003e\n \u003cli\u003eMale partner \u0026nbsp;and mother being in the third trimester of pregnancy\u003c/li\u003e\n \u003cli\u003eMale partner and healthy mother with no underlying disease.\u003c/li\u003e\n \u003cli\u003eMale partner and healthy mother with no pregnancy complication.\u003c/li\u003e\n \u003cli\u003eMale partner who live with their wives at home or maintain regular communication with them.\u003c/li\u003e\n \u003cli\u003ePartners capable of giving informed consent\u003c/li\u003e\n \u003cli\u003ePartners living in the selected cluster with no plans to move away during the intervention period\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e\u003cstrong\u003eExclusion criteria\u003c/strong\u003e\u003c/p\u003e\n\u003cul\u003e\n \u003cli\u003eMother who experienced a pregnancy loss (miscarriage, still birth, neonatal death) during the follow up period\u003c/li\u003e\n \u003cli\u003eMother had serious medical problems\u003c/li\u003e\n \u003cli\u003e\u0026nbsp;Couples \u0026nbsp; who divorced or separated or migrated out of the study area during the intervention\u003c/li\u003e\n \u003cli\u003eTwin gestation (known twin gestation will be excluded)\u003c/li\u003e\n \u003cli\u003eInfants admitted to neonatal ICUs at birth\u0026nbsp;\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eSample size determination\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe sample size (n) required for the study will be calculated with \u003cstrong\u003eG*Power\u003c/strong\u003e to estimate a two population proportion by considering the following assumptions.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAt baseline, 45.5 % of mothers use optimal breastfeeding practice at six months (20), and we are looking to see an improvement of 20% optimal breastfeeding practice by education and support intervention at six months in the intervention group.\u003c/p\u003e\n\u003cp\u003eA type I error of 5%\u003c/p\u003e\n\u003cp\u003eStrength of 80% with 95% CIs\u003c/p\u003e\n\u003cp\u003eA total of \u003cstrong\u003e170\u003c/strong\u003e father/mother pairs in each group will be needed.\u003c/p\u003e\n\u003cp\u003eAs this is a randomized design with clusters (each cluster is a kebeles), the sample size needs to be increased taking into account the effect of the design.\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eConsidering a design effect of \u003cstrong\u003e2\u003c/strong\u003e and a loss of follow-up of 20%, the total sample size will be \u003cstrong\u003e408 father/\u003c/strong\u003emother pairs (\u003cstrong\u003e204\u003c/strong\u003e in intervention and \u003cstrong\u003e204\u003c/strong\u003e in control groups). By assuming an intra-cluster correlation coefficient of 0\u0026middot;1 for a cluster size of 26, it will be calculated that we will need 16 clusters (Kebeles).\u003c/p\u003e\n\u003cp\u003eIn the two selected districts (Gibe and Soro) of Hadiya Zone, there are about 55 Kebeles, which is the lowest administrative unit in Ethiopia. \u0026nbsp;The 16 clusters (Kebeles) will be selected which is 30% of the total Kebeles in Gibe and Soro districts (8 intervention arms and 8 control arms).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eSampling and randomization procedures\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eFrom the 13 districts in Hadiya Zone, two districts will be selected purposively.\u0026nbsp;After identifying and listing the 55 Kebeles found in the selected districts or woredas, 16 non adjacent Kebeles will be selected.\u003c/p\u003e\n\u003cp\u003eThen eligible pregnant women will be identified from the selected Kebeles using the health extension worker\u0026rsquo;s logbook before the Kebeles are randomized into either the intervention or control groups.\u0026nbsp;Kebeles\u0026nbsp;found in the selected districts will form the unit of randomization for the trial, while father-mother pairs within the Kebeles will form units of observation or analysis.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eTo create comparable groups and remove the source of selection bias in the assignment of Kebeles to the intervention and control groups, the randomization will be carried out by an independent biostatistician (someone not participating in the study). Allocation concealment will be done for clusters, as they will not know if they will be in the intervention group or not. First cluster ID will be given like #1, #2, #3\u0026hellip;#16 then names of the sequentially numbered clusters with the given ID will be closed in an opaque envelope and a blinded randomizer (biostatistician) will produce comparable groups.\u003c/p\u003e\n\u003cp\u003eSimple randomization with a 1:1 allocation will be used to randomize Kebeles to either the control or intervention groups. First, 16 nonadjacent clusters will be selected purposively from Kebeles in two selected districts (Gibe and Soro) in the Hadiya Zone. Then, the 16 clusters (Kebeles) will be listed alphabetically by their name and closed in an opaque envelope with their ID. A list of random numbers will be generated in MS Excel 2010, and the generated values will be fixed by copying them as \u0026lsquo;values\u0026rsquo; next to the alphabetic list of the clusters. These will be arranged in ascending order according to the generated random number. Finally, the first eight clusters (Kebeles) will be selected as intervention clusters and the last eight as control clusters. Then, a simple random sampling technique will be performed to select mother-father pairs from each arm. We will select an equal number of participants from each cluster. The same sample of mother-father pairs will be used at the end of the intervention phase, nine months later, to measure the outcome variables (\u003cstrong\u003eFigure 1\u003c/strong\u003e).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eSingle-blinding will be applied, in which the outcome assessor (data collector) will be aware of the intervention allotted. Data collectors will be masked from the Kebeles allocation by not informing them of the allocation.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eRecruitment\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eHadiya Zone is one of the Southern Nations, Nationalities, and People Regional State of Ethiopia, which has 13 districts and four town administrations. According to different studies, the Southern Nations, Nationalities, and Peoples Regional State of Ethiopia is known for sub-optimal breastfeeding practices, which attracted the attention of the researchers to conduct this trial (21-24). Firstly, two (Soro and Gibe) districts will be identified from the Hadiya zones for this study. Then, sixteen geographically non-adjacent clusters, or Kebeles, will be identified from the existing Kebeles within the two study districts.\u003c/p\u003e\n\u003cp\u003eThe eligible pregnant women and their male partners will be identified from the selected Kebeles using the health extension worker\u0026rsquo;s logbook before the Kebeles are randomized into either the intervention or control group\u0026nbsp;using simple randomization techniques, but recruitment will be started after clusters have been randomized.\u003c/p\u003e\n\u003cp\u003eA sampling frame is then created. A simple random sampling technique is then used to select study participants from each cluster in each arm. The same number of participants is selected from each cluster. All non-adjacent kebele will be considered for the study, but only those that are sufficiently far from one another and have at least one kebele between clusters included for our trial that might act as a buffer area between them will be chosen. Informed consent will be obtained from each woman and her male partner prior to their inclusion in the trial. Those women and their male partners who consent to participate in the study will be included and requested to sign an informed consent to ensure voluntary participation. Once consent is obtained, each participant will be interviewed to complete a baseline survey in the third trimester of pregnancy. Similarly, end-line survey will be conducted after six months of post-delivery.\u003c/p\u003e\n\u003ch2\u003eSelection and training of research team\u003c/h2\u003e\n\u003cp\u003eThe research team will be composed of:\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eBreastfeeding educators or counselors\u003c/em\u003e: eight trained health care workers will be selected from the nearest health center to the intervention cluster (Kebeles). Criteria for selection will be:\u003c/p\u003e\n\u003col\u003e\n \u003cli\u003eGood command of Amharic and Hadiyisa (the local language).\u003c/li\u003e\n \u003cli\u003eGood interpersonal and communication skills.\u003c/li\u003e\n \u003cli\u003eStaff in the respective cluster and stay for an entire research period.\u003c/li\u003e\n\u003c/ol\u003e\n\u003cp\u003eThe educators or counselors will be trained for three days by the researcher. The training will cover paternal support and raised awareness about the components and importance of optimal breastfeeding practices. Communication and counseling skills will also be covered. A pre-test and post-test on breastfeeding knowledge will be administered to the educators or counselors before and after the training to ensure uniformity; all the educators or counselors should have to pass the test.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eEnumerators or outcome assessors:\u003c/em\u003e Data will be collected by 16 data collectors. The enumerators or data collectors will be trained for three days by the researcher. The training content included the study objectives, responsibilities of the data collectors, research instruments, and interview skills.\u003cem\u003e\u0026nbsp; \u0026nbsp;\u003c/em\u003ePractical demonstrations will be conducted to ensure that the enumerators or data collectors understand the questions and learn the appropriate interviewing skills.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eThe Intervention\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe intervention will be carried out continuously during both antenatal and postnatal periods from October 2022 to the end of August 2023. The intervention will be designed based on social cognitive theory (25). BF education and support intervention will be provided by trained health care workers selected from the nearest health center starting from the 3\u003csup\u003erd\u003c/sup\u003e trimester of pregnancy for both the male partner and mother, besides the routine information and education they get from health institutions as routine care.\u003c/p\u003e\n\u003cp\u003eThe intervention is composed of the following elements: i) antenatal and postnatal breastfeeding education to raise knowledge, awareness, support, and counseling on the benefits of optimal breastfeeding practices and involvement in supporting breastfeeding mothers; ii) Specific take-home print materials to be shared by both partners that support optimal breastfeeding practices; and iii) Individual home visits.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePaternal and maternal group education\u0026nbsp;\u003c/strong\u003ewill be given at their third trimester pregnancy for both the male partner and mother by preparing a small social event for 3 hours on the following topics: early BF initiation, importance of colostrum, BF on-demand and frequent feeds, benefits of EBF for infant and mother, positioning and attachment techniques during BF, dangers of pre-lacteal feeds, adequacy of breast milk for 6 months, dangers of breast milk substitutes, maternal diet and rest, continuing breastfeeding during sickness, and starting complementary feeding by the age of six months. The components of optimal breastfeeding practice messages delivered during group education for both partners are displayed in \u003cstrong\u003eTable 1.\u003c/strong\u003e\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"650\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"2\" valign=\"top\" style=\"width: 650px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eTable 1: Components of messages for promoting optimal breastfeeding practices for male partners and mothers\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 36px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e1\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 614px;\"\u003e\n \u003cp\u003eLearn to recognise basic information on the benefits of breastfeeding for the baby, mother, family, and communities.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 36px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e2\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 614px;\"\u003e\n \u003cp\u003ePut your baby on the breast immediately after birth, to stimulate your production of milk.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 36px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e3\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 614px;\"\u003e\n \u003cp\u003eFeed your baby the first yellow milk (colostrum) helps to protect the infant from illness.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 36px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e4\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 614px;\"\u003e\n \u003cp\u003eFeed your baby only breast milk for\u0026nbsp;the first six months, not even\u0026nbsp;giving water, for the baby to grow healthy and strong.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 36px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e5\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 614px;\"\u003e\n \u003cp\u003eBreastfeed your baby on demand, at least 10 times day and night,\u0026nbsp;to produce enough milk and provide your baby enough food to\u0026nbsp;grow healthy.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 36px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e6\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 614px;\"\u003e\n \u003cp\u003eStart giving complementary foods such as soft porridge 2-3 times a day for your baby when child completes 6 months in addition to breast milk to grow healthy and strong.\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 36px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e7\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 614px;\"\u003e\n \u003cp\u003eContinue to breastfeed your baby until two years and beyond to make it stay strong\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 36px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e8\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 614px;\"\u003e\n \u003cp\u003eEnsure\u0026nbsp;breastfeeding women need to eat 2 extra meals\u0026nbsp;a day to maintain her health and the health of the baby.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 36px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e9\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 614px;\"\u003e\n \u003cp\u003eContinue breastfeeding \u0026nbsp;your baby when either you or the infant is sick\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 36px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e10\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 614px;\"\u003e\n \u003cp\u003eAvoid\u0026nbsp;pre-lacteal feeds such as sugar water, water, butter, are not necessary and may interfere with establishing good breastfeeding practices during the first days of the baby\u0026rsquo;s life.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 36px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e11\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e12\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 614px;\"\u003e\n \u003cp\u003eNever use a bottle to feed your baby, as these are hard to keep clean and will cause diarrhea.\u003c/p\u003e\n \u003cp\u003eEnsure correct positioning and attachment for optimal breastfeeding\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u003cstrong\u003eSpecific take-home print materials\u003c/strong\u003e will be given to both the male partner and the mother during the third trimester of pregnancy. One poster for the male partner and one template for the mother will be provided at the time of group education on the third trimester of pregnancy. The content of the poster for husbands includes continued paternal psychological, physical, and social support for breastfeeding mothers. The content of the template for mother includes optimal breastfeeding practices. The concept of take-home print materials will be explained during the offering for those who cannot read, and they will be advised to ask the help of a family member or neighbor who can read.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eHome visit:\u0026nbsp;\u003c/strong\u003eIndividual counseling for male partners and mothers will be held at 6 weeks, 3.5 month and 5 months to remind the couples about optimal breastfeeding practices and male partners\u0026rsquo; involvement in supporting breastfeeding mothers.\u003c/p\u003e\n\u003cp\u003ePaternal supportive practices for breastfeeding mothers, such as household chores and responsibilities, caring for the baby, feeding the baby, caring for the mother, encouragement and motivation, being in agreement, and creating a favorable environment, will be delivered through take-home print materials and home visits in addition to optimal breastfeeding practice messages\u0026nbsp;(\u003cstrong\u003esee table 2\u003c/strong\u003e).\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"2\" valign=\"top\" style=\"width: 616px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eTable 2\u003c/strong\u003e: Key messages for the male partner to support breastfeeding mothers. Help breastfeeding mother with:\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 26px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e1\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 590px;\"\u003e\n \u003cp\u003eHousehold chores and responsibilities such as cleaning, cooking, home maintenance, shopping, laundry and bill pay\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 26px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e2\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 590px;\"\u003e\n \u003cp\u003eCaring for the baby such as bathing, putting to sleep, changing diapers, playing and soothing \u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 26px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e3\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 590px;\"\u003e\n \u003cp\u003eFeeding the baby such as swaddle baby after feeding, helps to burp baby after feeding, helps with positioning and latching\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 26px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e4\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 590px;\"\u003e\n \u003cp\u003eCaring for the mother such as allow mother time to sleep, rest, pump, break from baby, buy or prepare healthy foods to support or increase milk production\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 26px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e5\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 590px;\"\u003e\n \u003cp\u003eOffering word of encouragement and motivation such as \u0026lsquo;you can do it\u0026rsquo;, \u0026lsquo;keep going\u0026rsquo;, \u0026lsquo;I am proud of you\u0026rsquo; and practical support with BF challenges\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 26px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e6\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 590px;\"\u003e\n \u003cp\u003e\u0026nbsp;Being in agreement such as feel BF is joint responsibility, agrees on BF method and decision\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 26px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e7\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 590px;\"\u003e\n \u003cp\u003eMaking favourable environment such as create stress free environment mothers to breastfeed, keeps things positively and has positive attitude on BF\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eThe Control Group (CG)\u003c/strong\u003e will receive standard breastfeeding support (routine care), which will be given by health care professionals and HEW during antenatal or postnatal time. According to the Ethiopian Ministry of Health\u0026rsquo;s Health Extension Workers (HEW) program strategy, HEWs are female graduates with a certificate who are trained and deployed to work at the local health post at the kebele (lowest administrative unit in Ethiopia) level. HEW provides health-post-based IYCF counseling and education, including breastfeeding, to the mothers through the pregnant and lactating mother\u0026rsquo;s forum with the support of health care professionals from nearby health institutions (IYCF is one of the packages of health and nutrition interventions). In Ethiopia, HEW is focusing on the dyad\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e(mother and child) alone in breastfeeding promotion, which is not producing the results needed to make breastfeeding optimal and the cultural norm in infant feeding. Expanding the \u0026quot;breastfeeding dyad\u0026quot; to a \u0026quot;breastfeeding triad\u0026quot; recognizes the importance of the male partner in supporting and strengthening breastfeeding efforts and the impact that the informal support structure can have in promoting breastfeeding. Therefore, in our trial design, Control Group (CG) mothers will receive breastfeeding counseling and education as routine care from HEW; this is considered an intervention provided to the mothers alone. This group received no intervention from the research team.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eIntervention groups (IG)\u0026nbsp;\u003c/strong\u003ewill receive breastfeeding education and support for optimal breastfeeding practices.\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003eThe intervention activities will be designed and implemented to target male partners and pregnant mothers starting in their third trimester. Male partners and women in the intervention group will receive enhanced breastfeeding education and support starting from their third trimester pregnancy until 6 months post-delivery. In the intervention group, fathers and mothers will receive breastfeeding counseling and education. The summary of the intervention protocol is displayed in \u003cstrong\u003eTable 3.\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cbr\u003e\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"705\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"6\" valign=\"top\" style=\"width: 705px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eTable 3\u003c/strong\u003e:\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003eSummery of intervention protocol\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 36px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 191px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eContent\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eDose\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 128px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eFrequency\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 143px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eCompliance parameters\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 101px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eResponsible person\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 36px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e1\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 191px;\"\u003e\n \u003cp\u003ePaternal and maternal group education and counselling for fathers during last trimester\u003c/p\u003e\n \u003cp\u003e\u0026bull; by preparing small social event\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003e3 hours\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 128px;\"\u003e\n \u003cp\u003eOnce at their 3\u003csup\u003erd\u003c/sup\u003e trimester period\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 143px;\"\u003e\n \u003cp\u003e-% male partners participated\u003c/p\u003e\n \u003cp\u003e-% mothers participated\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 101px;\"\u003e\n \u003cp\u003eresearcher\u003c/p\u003e\n \u003cp\u003eeducators or counsellors\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 36px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e2\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 191px;\"\u003e\n \u003cp\u003eProviding specific take-home print materials\u003c/p\u003e\n \u003cp\u003eMaternal OBF practices\u003c/p\u003e\n \u003cp\u003e\u0026bull; paternal support practice\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003e-One poster for father and\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e-one template for mother\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 128px;\"\u003e\n \u003cp\u003eOnce in the \u0026nbsp;3\u003csup\u003erd\u003c/sup\u003e trimester \u0026nbsp;pregnancy\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 143px;\"\u003e\n \u003cp\u003e-% of fathers received print materials\u003c/p\u003e\n \u003cp\u003e-% mothers received print materials\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 101px;\"\u003e\n \u003cp\u003eeducators or counsellors\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 36px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e3\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 191px;\"\u003e\n \u003cp\u003e\u0026bull; Home visit\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026bull; Individual counseling for male partners and mothers\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003e20minutes\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 128px;\"\u003e\n \u003cp\u003eThree time at \u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026bull; 6\u003csup\u003eth\u003c/sup\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp;week\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026bull; 3.5 month\u003c/p\u003e\n \u003cp\u003e\u0026bull; 5\u003csup\u003eth\u003c/sup\u003e month postpartum\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 143px;\"\u003e\n \u003cp\u003e% father counselled\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e% mother counselled\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 101px;\"\u003e\n \u003cp\u003eeducators or counsellors\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 36px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e4\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 191px;\"\u003e\n \u003cp\u003eEnd line data collection\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003e30\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 128px;\"\u003e\n \u003cp\u003eat 6\u003csup\u003eth\u003c/sup\u003e month of post-delivery\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 143px;\"\u003e\n \u003cp\u003e% father interview\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e% mother interview\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 101px;\"\u003e\n \u003cp\u003eData collectors.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eVariables\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ePrimary outcome variable\u003c/p\u003e\n\u003cul\u003e\n \u003cli\u003eOptimal breastfeeding practice\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003eSecondary outcome variables\u003c/p\u003e\n\u003cul\u003e\n \u003cli\u003ePaternal knowledge, attitude and supportive practices\u003c/li\u003e\n \u003cli\u003eBreastfeeding Self-Efficacy\u003c/li\u003e\n \u003cli\u003ePrevalence of child morbidity\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eMaternal Perceptions on husbands\u0026rsquo; breastfeeding support\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eData collection\u003c/em\u003e\u003c/strong\u003e \u003cstrong\u003e\u003cem\u003emethod\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eData will be collected with 16 data collectors through a face-to-face interview by trained nurses or midwives who are working in the nearest health center for a specific cluster and have not participated in the intervention. Baseline data will be collected from pregnant mothers and male partners in their 3\u003csup\u003erd\u003c/sup\u003e trimester. End-line data with all other outcome variables will be collected at the 6th month post-delivery.\u003c/p\u003e\n\u003cp\u003eBasic socio-demographic and economic characteristics, maternal and pregnancy factors, and previous infant feeding experience of the partners will be collected at baseline. Data on knowledge, attitude, and involvement in supportive practice by the male partner, breastfeeding self-efficacy, and the perception of mothers on their husbands support will also be collected at the base line and end line. Data on new-borns, the maternity experience of the mother, and optimal breastfeeding practices will be collected at the end line, which is 6 months after delivery.\u003c/p\u003e\n\u003cp\u003eThe baseline and end-line questionnaires will include several previously validated and widely used instruments to measure factors associated with optimal breastfeeding outcomes. These will include the Iowa Infant Feeding Attitude Scale, the Breastfeeding Self-Efficacy Scale, and the Postpartum Partner Support Scale.\u003c/p\u003e\n\u003cp\u003eBaseline data will be collected in the 3\u003csup\u003erd\u003c/sup\u003e trimester of pregnancy before the administration of the intervention.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eStudy outcomes measures\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e1. Fathers\u0026rsquo; breastfeeding knowledge will be assessed using a questionnaire adapted from the Food and Agricultural Organization (FAO) of the United Nations (UN) (26). This questionnaire has 16 questions, which will be coded into Yes or No responses, and one mark will be awarded for every correct response (yes), and zero will be awarded for every incorrect response (no). Hence, the total number of marks in the knowledge section ranged from 0 to 16. Male partners who score above the mean will be considered knowledgeable and those who score below the mean will be considered not knowledgeable.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eBreastfeeding attitudes will be measured using the Iowa Infant Feeding Attitude Scale (IIFAS). This tool has 17 questions and uses a 5 point Likert scale with options such as strongly agree to strongly disagree for each item. The total score will be calculated out of 85, with a minimum of 17 and a maximum of 85. This scale will help to identify the attitude of the male partner by capturing the favourable attitude (above the mean score) and unfavourable attitude (below the mean score) towards breastfeeding (27).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eThe supportive practice\u003c/strong\u003e of male partners in optimal breastfeeding practice will be measured by using a questionnaire adopted from the literature (28). This questionnaire has 8 questions, which will be coded into Yes or No responses, and one mark will be awarded for every correct response (yes), and zero will be awarded for every incorrect response (no). Hence, the total number of marks in the \u003cstrong\u003es\u003c/strong\u003e\u003cstrong\u003eupportive practice\u003c/strong\u003e ranged from 0 to 8. Male partners\u0026rsquo; who score above the mean will be considered to have \u003cstrong\u003esupportive practice,\u003c/strong\u003e and those who score below the means will be considered to a not \u003cstrong\u003es\u003c/strong\u003e\u003cstrong\u003eupportive practice.\u003c/strong\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e2.\u003c/strong\u003e In this study, mothers will be asked about infant breastfeeding practice, includes Early initiation of BF, breastfeeding frequently day and night (on demand), giving infants only breast milk for the first 6 months, the intended duration of breastfeeding, pre-lacteal feeding, and a history of feeding colostrum.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eExclusive breastfeeding at 6 months is measured as the proportion of women who provided their infants with only breast milk but no solids, nonhuman milk, water, or other liquids (other than vitamins or medications) at 6 months. Exclusive breastfeeding practices will be identified using various methods including the last 24 hours, the last week, and since-birth recalls. The duration of exclusive breastfeeding will be identified by asking the mother to recall the time when she stopped EBF with the child.\u003c/p\u003e\n\u003cp\u003eOn-demand breastfeeding will be measured by asking mothers about breastfeeding frequency greater than or equal to 8 times per 24 hours. Pre-lacteal feeding will be measured by asking mothers whether they pre-lacteally feed their child within three days of delivery. Colostrum feeding will be measured by asking mothers about the history of feeding the first yellow milk to their child.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe infant breastfeeding practice scores will be summed to give a total score that could range between 0 and 6. The infant breastfeeding practice scores will then be classified as Poor (0\u0026ndash;2), Medium (3\u0026ndash;4), or Good (5\u0026ndash;6). When the study subjects have scored the highest tertile (good) of infant breastfeeding practice scores, they will be considered \u003cstrong\u003eoptimal breastfeeding\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003epractices,\u003c/strong\u003e and the lowest two tertiles (poor and medium) of infant breastfeeding practice scores will be merged and will be considered \u003cstrong\u003esub-optimal breastfeeding practices.\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eTo reduce recall bias at 6 months, optimal breastfeeding practices (early initiation of breastfeeding, exclusive breastfeeding, and frequency of breastfeeding day and night (on demand)) will be measured in three ways: the last 24 hours recall, the last week\u0026apos;s recall, and the since birth recall. The mother will be probed to recall her breastfeeding practices. The criteria for scoring breastfeeding practices are displayed in \u003cstrong\u003eTable 4.\u003c/strong\u003e\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"640\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"4\" valign=\"top\" style=\"width: 640px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eTable 4\u003c/strong\u003e\u003cstrong\u003e:\u0026nbsp;\u003c/strong\u003eThe criteria for scoring optimal breastfeeding practices for infants-age 0\u0026ndash;6 months\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 36px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 387px;\"\u003e\n \u003cp\u003eInfant feeding components\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"2\" valign=\"top\" style=\"width: 217px;\"\u003e\n \u003cp\u003eResponse\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 36px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e1\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 387px;\"\u003e\n \u003cp\u003eEarly initiation of BF \u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026lt;=1 hours=1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u0026gt;1 hours=0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 36px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e2\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 387px;\"\u003e\n \u003cp\u003ebreastfeeding frequently day and night (on demand)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u0026gt;8= 1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e\u0026lt;8= 0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 36px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e3\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 387px;\"\u003e\n \u003cp\u003egiving infant only breast milk for the first 6 months(EBF)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;Yes=1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003eNo= 0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 36px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e4\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 387px;\"\u003e\n \u003cp\u003eintended duration of breastfeeding\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp; \u0026gt;=2 years=1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e\u0026lt;2years= 0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 36px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e5\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 387px;\"\u003e\n \u003cp\u003epre-lacteal feeding\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp; No=1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003eYes= 0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 36px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e6\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 387px;\"\u003e\n \u003cp\u003efeeding colostrum\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp; Yes=1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e\u0026nbsp; No=0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 36px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 387px;\"\u003e\n \u003cp\u003eRange of total score\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"2\" valign=\"top\" style=\"width: 217px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;0-6\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e3.\u003c/strong\u003e Breastfeeding Self-Efficacy (BSE) refers to a mother\u0026rsquo;s confidence in her ability to breastfeed her infant.\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003eData on maternal BF self-efficacy will be collected at baseline and at the end line. The breastfeeding Self-Efficacy Scale-Short Form, developed to assess breastfeeding self-efficacy during the postnatal period, is a 14-item self-report instrument scored on a 5-point Likert-type scale where 1 = not at all confident and 5 = very confident. Items are presented positively and summed to produce a total score ranging from 14 to 70, with higher scores indicating higher levels of breastfeeding self-efficacy (29).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e4.\u0026nbsp;\u003c/strong\u003eMorbidity status will be an outcome variable. Three morbidities will be used to determine a child\u0026apos;s morbidity status: diarrhea, fever, and acute respiratory infections (ARIs). The following questions will be used to determine diarrhea and fever in this study: Has the child experienced diarrhea in the last two weeks? Secondly, has the child experienced any recent fever in the past two weeks?\u0026nbsp;The women\u0026apos;s answers to the following questions will be used to determine if they have acute respiratory illnesses: A) Has the child experienced a cough-accompanied illness within the previous two weeks? b) Did the child have\u0026nbsp;difficulty\u0026nbsp;breathing or breathe more quickly than normal when they had an illness with a cough? and c) was the fast or\u0026nbsp;difficulty\u0026nbsp;breathing brought on by a chest issue or a\u0026nbsp;blocked\u0026nbsp;or runny nose?\u003c/p\u003e\n\u003cp\u003eThe women\u0026apos;s answers to the following questions will be used to determine if they have acute respiratory illnesses: A) Has the child experienced a cough-accompanied illness within the previous two weeks? b) Did the child have\u0026nbsp;difficulty\u0026nbsp;breathing or breathe more quickly than normal when they had an illness with a cough? and c) was the fast or\u0026nbsp;difficulty\u0026nbsp;breathing brought on by a chest issue or a\u0026nbsp;blocked\u0026nbsp;or runny nose?\u003c/p\u003e\n\u003cp\u003eChildren with at least one of the three morbidities during the intervention period will be considered to have a high frequency of morbidity; otherwise, there will be no morbidity in the child during the intervention period (30).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e5.\u003c/strong\u003e Husbands\u0026rsquo; support for breastfeeding will be defined as the physical, emotional, and psychosocial support the mother receives from her husband during breastfeeding. Physical support refers to helping during positioning the mother for breastfeeding, helping in breastfeeding at night, helping in child care activities and household work, and seeking service from a healthcare provider for breastfeeding problems. Emotional and psychosocial support refers to encouraging women verbally to breastfeed, encouraging them to breastfeed in public areas, and involving them in the decision-making process to breastfeed.\u003c/p\u003e\n\u003cp\u003eMaternal perceptions of husbands\u0026rsquo; breastfeeding support will be measured by the postpartum partner support scale, a 25-item self-report instrument designed to assess partner postpartum perceptions of support. Items are rated on a 4-point scale to produce a summative score ranging from 25 to 100, with higher scores indicating higher levels of maternal perceptions of postpartum-specific partner support (6). Outcomes will be assessed as illustrated in the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) (\u003cstrong\u003esee table 5).\u003c/strong\u003e\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"659\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"7\" valign=\"top\" style=\"width: 659px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eTable 5:\u0026nbsp;\u003c/strong\u003eStandard Protocol Items: Recommendations for Interventional Trials (SPIRIT)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"3\" rowspan=\"3\" valign=\"top\" style=\"width: 206px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003eOutcomes\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"2\" valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003eAllocation\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"3\" valign=\"top\" style=\"width: 369px;\"\u003e\n \u003cp\u003eStudy period\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"2\" valign=\"top\" style=\"width: 227px;\"\u003e\n \u003cp\u003eEnrolment\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 142px;\"\u003e\n \u003cp\u003eClose-out\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e-t1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 76px;\"\u003e\n \u003cp\u003eBaseline (t0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 151px;\"\u003e\n \u003cp\u003eIntervention from 3\u003csup\u003erd\u003c/sup\u003e trimester to 6\u003csup\u003eth\u003c/sup\u003e month after delivery\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 142px;\"\u003e\n \u003cp\u003eEnd line at month 6 after delivery (t1)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"3\" valign=\"top\" style=\"width: 26px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e1\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"3\" valign=\"top\" style=\"width: 94px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eEnrolment\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003eAllocation\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003ex\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 76px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 151px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 142px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eEligibility screen\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 76px;\"\u003e\n \u003cp\u003ex\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 151px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 142px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eInformed consent\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 76px;\"\u003e\n \u003cp\u003ex\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 151px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 142px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 26px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e2\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"2\" valign=\"top\" style=\"width: 180px;\"\u003e\n \u003cp\u003eInterventions\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 76px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 151px;\"\u003e\n \u003cp\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;x\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 142px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 26px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e3\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"2\" valign=\"top\" style=\"width: 180px;\"\u003e\n \u003cp\u003eSocio-demographics of both partner\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 76px;\"\u003e\n \u003cp\u003ex\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 151px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 142px;\"\u003e\n \u003cp\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; x\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 26px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e4\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"2\" valign=\"top\" style=\"width: 180px;\"\u003e\n \u003cp\u003eBase line male partners\u0026rsquo; knowledge, attitude and \u003cstrong\u003esupportive practice\u003c/strong\u003e on optimal breastfeeding\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 76px;\"\u003e\n \u003cp\u003ex\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 151px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 142px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 26px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e5\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"2\" valign=\"top\" style=\"width: 180px;\"\u003e\n \u003cp\u003eChange in male partners\u0026rsquo; knowledge, attitude and \u003cstrong\u003esupportive practice\u003c/strong\u003e on optimal breastfeeding\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 76px;\"\u003e\n \u003cp\u003ex\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 151px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 142px;\"\u003e\n \u003cp\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; x\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 26px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e6\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"2\" valign=\"top\" style=\"width: 180px;\"\u003e\n \u003cp\u003eOptimal breastfeeding practices\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 76px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 151px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 142px;\"\u003e\n \u003cp\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;x\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 26px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e7\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"2\" valign=\"top\" style=\"width: 180px;\"\u003e\n \u003cp\u003eMother\u0026apos;s BF self-efficacy\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 76px;\"\u003e\n \u003cp\u003ex\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 151px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 142px;\"\u003e\n \u003cp\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; x\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 26px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e8\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"2\" valign=\"top\" style=\"width: 180px;\"\u003e\n \u003cp\u003eFrequency of child morbidity\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 76px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 151px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 142px;\"\u003e\n \u003cp\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; x\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 26px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e9\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"2\" valign=\"top\" style=\"width: 180px;\"\u003e\n \u003cp\u003eMaternal perception on husbands support\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 76px;\"\u003e\n \u003cp\u003ex\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 151px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 142px;\"\u003e\n \u003cp\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; x\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eData management and analysis\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe data will be entered into a computer using Epi Data 3.1 and analyzed using STATA Window version 14.0. All statistical significance will be declared at a P-value less than 0.05. The analysis will be done using an intention to treat approach.\u003c/p\u003e\n\u003cp\u003eThe baseline characteristics will be compared using the chi-square test for categorical variables and the independent t-test for continuous variables. A paired t-test will be used to analyze the difference between the mean of paternal knowledge and attitude, self-efficacy scores, and maternal perception on husband support scale scores in the intervention group before and after intervention and the difference in the mean in the control group before and after intervention.\u003c/p\u003e\n\u003cp\u003ePearson\u0026rsquo;s correlation will be used to determine if there will be a relationship between maternal perception on the husband support scale and breastfeeding self-efficacy and optimal breastfeeding. The Poisson regression analysis will be applied to examine the effect of the intervention on childhood morbidity compared to control. Logistic regression analysis will be used to determine the significance of the association between paternal knowledge and attitude as independent variables. Linear regression will be used to see the association between maternal perceptions on the husband support scale as continuous outcome variable and other covariates. Finally, a Generalized Estimating Equations (GEE) model that controls for within-Kebele clustering will be used to estimate the effect of the intervention on optimal breastfeeding practice and breastfeeding self-efficacy scores at 6 months post-delivery.\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003eIn all analyses, the adjustment will be made for clustering at the Kebele level since randomization was done at the cluster level rather than the individual level.\u003c/p\u003e\n\u003cp\u003eThe audio-recorded data during the FGD and in-depth interview will be first transcribed in the local language (Hadiyisa) immediately after completion, translated into English, and then imported into Atlas Ti7 software for thematic analysis. Credibility will be ensured by peer debriefing, prolonged engagement, clarifying researcher bias, quotes in the manuscript, and member checking. Dependability will be ensured by a rich description of the research methods, ensuring and measuring coding accuracy and intercoders\u0026rsquo; reliability. Conformability will be ensured by reflexivity and triangulation (methodological, data source, investigators, and theoretical). Transferability will be ensured by purposeful sampling, data saturation, and comparing results.\u003c/p\u003e\n\u003ch2\u003eData quality control\u003c/h2\u003e\n\u003cp\u003eThe data collectors will be recruited and trained for two days. Questionnaires will be prepared first in English by the investigator and then translated to Amharic (the working language) by another individual who is native to Amharic (the working language). The questionnaire\u0026nbsp;will be\u0026nbsp;translated back into English by another individual to maintain its consistency. Questionnaires will be developed utilizing questions previously validated in the other study.\u003c/p\u003e\n\u003cp\u003eThe FAO and IIFAS questionnaires have been field-tested in several countries to ensure validity, readability, ease of administration, and less burdensomeness on respondents. Thus, the questionnaire formulated based on the FAO, BSE, and IIFAS questionnaires will be pre-tested on 5% of mother-male partner pairs for the purpose of precision, validity, and ease of data collection.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAll tools will be pre-tested in one Kebele not included in the study to make necessary amendments to the tools. The baseline and follow-up questionnaires will include many previously validated and widely used instruments to measure optimal breastfeeding practices.\u003c/p\u003e\n\u003cp\u003eThe selected and trained supervisors will supervise the data collector on a daily basis for completeness and consistency of the tool. Additionally, prior to the analysis, the data will be meticulously cleansed and fed into the computer.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eDissemination plan\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe findings of this trial will be presented to the Southern Nations, Nationalities, and Peoples Regional State of Ethiopia and relevant stakeholders in the local community. Papers from this trial will be published in peer-reviewed journals and communicated to the scientific community. Moreover, findings will be presented at national and international conferences and workshops.\u0026nbsp;\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eThe aim of the trial is to evaluate a community-based educational intervention targeting male partners at both antenatal and postnatal periods for supporting optimal breastfeeding practices by considering Ethiopians socio-economic and cultural context during the design and implementation of the intervention.\u003c/p\u003e\n\u003cp\u003eAt the start of the trial, counseling through phone contactswas included as part of an intervention package. However, when recruitment was started, we cancelled counseling through phone contacts from the intervention package due to the poor phone penetration rate in the study area, and even some of the participants have no phone, which may introduce an uncontrollable bias. Intervention implementers will not be part of the team collecting outcome data. This trial is designed to assess outcomes within the common intervention duration of 9 months\u003c/p\u003e\n\u003cp\u003eSeveral studies have examined the effectiveness of breastfeeding education and support interventions that target male partners\u0026nbsp;(31-34). \u0026nbsp; \u0026nbsp;However, interventions delivered through a community-based approach that targets male partners to improve optimal breastfeeding practices in mothers in LMICs have not been sufficiently investigated.\u003c/p\u003e\n\u003cp\u003eResults of the trial will provide evidence of the effectiveness of male partner-focused breastfeeding education and support interventions on optimal breastfeeding practices in community settings in South Ethiopia. The study findings will inform policymakers and practitioners on targeting male partners to stimulate their engagement and establish male partner contributions to supporting optimal breastfeeding practices.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eTrial status\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll trial participants have been recruited from the selected clusters, and baseline data have been collected. Training of intervention implementers (health care workers from the nearest health institution) in the intervention arm is completed, and specific take-home print materials (a poster and template) are prepared for both the mother and male partner in Amharic.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003eBF: Breastfeeding; BSE: Breastfeeding Self-Efficacy; CG: Control Group; CI: Confidence Interval; EBF: Exclusive Breastfeeding; FGD: Focus Group Discussion; GEE: Generalized Estimating Equation; HEW: Health Extension Worker; IG: Intervention Group; IIFAS: Iowa Infant Feeding Attitude Scale; IYCF: Infant and Young Child Feeding; LMIC: Low- and Middle-Income Countries; WHO: World Health Organization\u003c/p\u003e\n\u003cp\u003e\u003cbr\u003e\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003e\u003cem\u003eCompeting interests\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare that they have no competing interests.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eAuthors’ contributions\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eMA and TB wrote the first draft, participated in the trial design, and reviewed subsequent drafts leading to the final manuscript. MA wrote the original draft. MA and TB reviewed the final draft of the protocol. Both authors read and approved the final protocol.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eAcknowledgements\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe would like to acknowledge the support provided by the\u0026nbsp;Nestlé Foundation for the study of problems of nutrition in the world, Lausanne, Switzerland. The trial team wishes to acknowledge\u0026nbsp;Jimma University and Wachemo University for their grant and ethical approval.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eFunding\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis cluster randomised trial is supported by a grant from the Nestlé Foundation for the study of problems of nutrition in the world, Lausanne, Switzerland and Jimma University.\u0026nbsp;The study sponsor and funder have no role in the\u0026nbsp;design of the study and collection, analysis, and interpretation of data, and the writing of the manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eEthics approval and consent to participate\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe protocol was reviewed and approved by Jimma University Institutional review board (JUIRB) (reference number JUIRB37/22) and Wachemo University Research Ethics Committee (WCUREC) (reference number WCU.RE.Dev.Di/010/2015). The investigator will duly inform the subjects that participate in the study and will request their informed consent, signed and dated in writing. He or she will provide complete and adequate verbal and written information about the nature, purpose, and possible risks and benefits of the study. The purpose of the study will be explained to the study subjects. At the time of data collection, verbal consent will be taken from the participants to confirm whether they are willing to participate. Those not willing to participate will be given the right to do so. The confidentiality of responses will also be ensured throughout the research process. Written permission will be asked for audio recording of the conversation during FGDs and KIIs. The respondents will be informed that their identity and the evidence they provide will be kept private. The willingness of participants will be asked for the home visit for the issue of privacy. COVID-19 infection prevention precautions will be strictly applied to study participants, educators, and data collectors. A face mask and sanitizer will be provided for data collectors and educators to use during the data collection and intervention periods. Standard physical distancing between study participants, educators, and data collectors to prevent COVID-19 will be applied throughout the study period.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eAvailability of data and materials\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eData sharing is not applicable to this protocol as no datasets are generated or analysed yet.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eConsent for publication\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eWHO. Infant and young child feeding: model chapter for textbooks for medical students and allied health professionals 2009.\u003c/li\u003e\n\u003cli\u003eUNICEF W. Global Breastfeeding Collective. Global Breastfeeding Scorecard, 2017: Enabling women to breastfeed through better policies and programmes. . New York, Geneva 2018.\u003c/li\u003e\n\u003cli\u003eAgency CS. Ethiopian Demographic and health survey 2019, Ethiopia ORC Macro Calverton Maryland, USA July 2019; 2019.\u003c/li\u003e\n\u003cli\u003eWHO. Guideline: protecting, promoting and supporting breastfeeding in facilities providing maternity and newborn services. Geneva:: World Health Organization; 2017. p. Licence: CC BY-NC-SA 3.0 IGO.\u003c/li\u003e\n\u003cli\u003eBrown A, Davies R. Fathers' experiences of supporting breastfeeding: challenges for breastfeeding promotion and education. Matern Child Nutr. 2014;10(4):510-26.\u003c/li\u003e\n\u003cli\u003eAbbass-Dick J, Stern SB, Nelson LE, Watson W, Dennis CL. Coparenting breastfeeding support and exclusive breastfeeding: a randomized controlled trial. Pediatrics. 2015;135(1):102-10.\u003c/li\u003e\n\u003cli\u003eBich TH, Hoa DT, Ha NT, Vui le T, Nghia DT, Malqvist M. Father's involvement and its effect on early breastfeeding practices in Viet Nam. Matern Child Nutr. 2016;12(4):768-77.\u003c/li\u003e\n\u003cli\u003eMerritt R, Vogel M, Ladbury P, Johnson S. A qualitative study to explore fathers' attitudes towards breastfeeding in South West England. Primary health care research \u0026amp; development. 2019;20:e24.\u003c/li\u003e\n\u003cli\u003eTohotoa J, Maycock B, Hauck YL, Howat P, Burns S, Binns CW. Dads make a difference: an exploratory study of paternal support for breastfeeding in Perth, Western Australia. International breastfeeding journal. 2009;4:15.\u003c/li\u003e\n\u003cli\u003eYourkavitch JM, Alvey JL, Prosnitz DM, Thomas JC. Engaging men to promote and support exclusive breastfeeding: a descriptive review of 28 projects in 20 low- and middle-income countries from 2003 to 2013. Journal of Health, Population and Nutrition. 2017;36(1).\u003c/li\u003e\n\u003cli\u003eCohen R, Lange L, Slusser W. A description of a male-focused breastfeeding promotion corporate lactation program. Journal of human lactation : official journal of International Lactation Consultant Association. 2002;18(1):61-5.\u003c/li\u003e\n\u003cli\u003eTohotoa J, Maycock B, Hauck Y, Howat P, Burns S, Binns C. Supporting mothers to breastfeed: the development and process evaluation of a father inclusive perinatal education support program in Perth, Western Australia. Health Promot Int. 2011;26(3):351-61.\u003c/li\u003e\n\u003cli\u003eTadesse K, Zelenko O, Mulugeta A, Gallegos D. Effectiveness of breastfeeding interventions delivered to fathers in low- and middle-income countries: A systematic review. Matern Child Nutr. 2018;14(4):e12612.\u003c/li\u003e\n\u003cli\u003eAbdulahi M, Fretheim A, Magnus JH. Effect of breastfeeding education and support intervention (BFESI)\u0026nbsp;versus routine care on timely initiation and exclusive breastfeeding in Southwest Ethiopia: study protocol for a cluster randomized controlled trial. BMC Pediatrics. 2018;18(1).\u003c/li\u003e\n\u003cli\u003eBelay S, Haidar J. Effect of prenatal education on breastfeeding initiation and exclusive breast feeding rate in selected health institutions of Hawassa city, the capital of SNNPR , Ethiopia. East African journal of public health. 2013;10:622-31.\u003c/li\u003e\n\u003cli\u003eAdmasu J, Egata G, Bassore DG, Feleke FW. Effect of maternal nutrition education on early initiation and exclusive breast-feeding practices in south Ethiopia: a cluster randomised control trial. Journal of nutritional science. 2022;11:e37.\u003c/li\u003e\n\u003cli\u003eGoodman JH. Becoming an Involved Father of an Infant. Journal of Obstetric, Gynecologic \u0026amp; Neonatal Nursing. 2005;34(2):190-200.\u003c/li\u003e\n\u003cli\u003eMitchell-Box K, Braun KL. Fathers' thoughts on breastfeeding and implications for a theory-based intervention. Journal of obstetric, gynecologic, and neonatal nursing : JOGNN. 2012;41(6):E41-50.\u003c/li\u003e\n\u003cli\u003ede Montigny F, Lacharit\u0026eacute; C. Fathers\u0026rsquo; Perceptions of the Immediate Postpartal Period. Journal of Obstetric, Gynecologic \u0026amp; Neonatal Nursing. 2004;33(3):328-39.\u003c/li\u003e\n\u003cli\u003eHagos A. Individual and community-level factors influencing optimal breastfeeding: A multilevel analysis from a national survey study in Ethiopia. 2016.\u003c/li\u003e\n\u003cli\u003eDessalegn Tamiru\u0026sup1; , M. Sc, Binyam Bogale\u0026sup2;, MPH, Behailu Merdikios\u0026sup3;, MGH. Breastfeeding patterns and factors associated with exposure to Sub-optimal breastfeeding practices in rural communities of Arba Minch Zuria, Ethiopia. Global Health Perspectives \u0026middot;. 2013;01(02).\u003c/li\u003e\n\u003cli\u003eAbageda M, Mokonen A, Hamdela B. Predictors of Optimal Breastfeeding Practices Among Mothers Who Have Less Than 24 Months of Age Children in Misha District, Hadiya Zone, South Ethiopia. J Preg Child Health. 2015;2:182.\u003c/li\u003e\n\u003cli\u003eAwoke N, Tekalign T, Lemma T. Predictors of optimal breastfeeding practices in Worabe town, Silte zone, South Ethiopia. PloS one. 2020;15(4):e0232316.\u003c/li\u003e\n\u003cli\u003eShibru Hoche BM, Negash Wakgari. Sub-Optimal Breast Feeding and Its Associated Factors in Rural Communities of Hula District, Southern Ethiopia: A Cross-Sectional Study. Ethiop J Health Sci. 2017;28(1):49.\u003c/li\u003e\n\u003cli\u003eBandura A. Health promotion from the perspective of social cognitive theory. Psychology and health. 1998;13(4):623-49.\u003c/li\u003e\n\u003cli\u003eMar\u0026iacute;as YFaPG. Guidelines for assessing nutrition-related knowledge, attitudes and practices. Rome: Food and Agriculture Organization of the United Nations (FAO); 2014. p. vi + 180 pp.\u003c/li\u003e\n\u003cli\u003ede la Mora A, Russell D, Dungy C, Losch M, Dusdieker L. The Iowa Infant Feeding Attitude Scale: Analysis of Reliability and Validity1. Journal of Applied Social Psychology - J APPL SOC PSYCHOL. 1999;29:2362-80.\u003c/li\u003e\n\u003cli\u003eDinga LA K-MB, Kyallo F. fathertargeted-nutrition-education-improves-early-initiation-and-breastfeeding-exclusivity-the-case-of-kisumu-county-kenya.pdf. J Food Sci Nutr. 2018;1(3):12-7.\u003c/li\u003e\n\u003cli\u003eDennis CL. The breastfeeding self-efficacy scale: psychometric assessment of the short form. Journal of obstetric, gynecologic, and neonatal nursing : JOGNN. 2003;32(6):734-44.\u003c/li\u003e\n\u003cli\u003eNigatu D, Azage M, Motbainor A. Effect of exclusive breastfeeding cessation time on childhood morbidity and adverse nutritional outcomes in Ethiopia: Analysis of the demographic and health surveys. PloS one. 2019;14(10):e0223379.\u003c/li\u003e\n\u003cli\u003eOzluses E, Celebioglu A. Educating fathers to improve breastfeeding rates and paternal-infant attachment. Indian pediatrics. 2014;51(8):654-7.\u003c/li\u003e\n\u003cli\u003ePisacane A, Continisio GI, Aldinucci M, D'Amora S, Continisio P. A controlled trial of the father's role in breastfeeding promotion. Pediatrics. 2005;116(4):e494-8.\u003c/li\u003e\n\u003cli\u003eSu M, Ouyang YQ. Father's Role in Breastfeeding Promotion: Lessons from a Quasi-Experimental Trial in China. Breastfeeding medicine : the official journal of the Academy of Breastfeeding Medicine. 2016;11:144-9.\u003c/li\u003e\n\u003cli\u003eSusin LR, Giugliani ER. Inclusion of fathers in an intervention to promote breastfeeding: impact on breastfeeding rates. Journal of human lactation : official journal of International Lactation Consultant Association. 2008;24(4):386-92; quiz 451-3.\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":true,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Cluster randomised trial, optimal breastfeeding practice, male partner, education and support, Ethiopia","lastPublishedDoi":"10.21203/rs.3.rs-3284805/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-3284805/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground: \u003c/strong\u003eOptimal breastfeeding is essential for the survival, growth, and development of children, as well as the health of mothers.\u0026nbsp; Globally, optimal breastfeeding practices are still low: only 42% of newborns start breastfeeding within the first hour of birth, 41% of infants less than 6 months of age are exclusively breastfed, and only 45% of mother’s breastfeed for at least two years. Every year, it is estimated that optimal breastfeeding practices might avoid 823,000 child deaths. However, breastfeeding practices are not optimal in Ethiopia. Male partners play a vital but frequently neglected role in the promotion of breastfeeding practices, and they are not included in the breastfeeding education. The effect of interventions to promote breastfeeding that specifically target male partners on optimal breastfeeding practices has not been investigated in the Ethiopian context.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods:\u003c/strong\u003e A parallel cluster-randomized controlled trial will be conducted to evaluate the effect of breastfeeding education and support provided to male partners on optimal breastfeeding practice compared to routine care at the community level. Trained healthcare professionals chosen from the closest health center to the intervention cluster will provide the intervention to the mothers and male partners. The mothers and male partners in the Intervention Group (IG) will receive both antenatal and postnatal breastfeeding education and support starting from their 3\u003csup\u003erd\u003c/sup\u003e trimester of pregnancy till 6 month post-delivery, but those in the Control Group (CG) will receive routine care. The breastfeeding education and support intervention is comprised of four components: 1) Antenatal BF education on their 3\u003csup\u003erd\u003c/sup\u003e trimester of pregnancy, 2) providing specific take-home print materials, 3) Individual home visit\u003cstrong\u003e. \u003c/strong\u003eA total of 408 couples with pregnancies in the third trimester from 16 clusters (Kebeles) will be randomly assigned to the intervention group (204) or the control group (204). Epi-data version 3.1 will be used to enter data, and STATA version 14.0 will be used to analyze it. The analysis will be done by intention to treat approach. Generalized Estimating Equation (GEE) model will be used to determine the effect of the intervention on optimal breastfeeding practice. P values \u0026lt; 0.05 will be used to declare statistical significance.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDiscussion:\u003c/strong\u003e The results of the trial will provide evidence of the effectiveness of male partner-focused breastfeeding education and support interventions on optimal breastfeeding practices in community settings in Ethiopia. The study's findings will help policymakers and practitioners understand how to best involve male partners and establish their contributions to breastfeeding best practices.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTrial registration: \u003c/strong\u003eClinicalTrials.gov identifier (NCT number): NCT05173454,\u003cem\u003e\u003cstrong\u003e \u003c/strong\u003e\u003c/em\u003eMay 20, 2022.\u003c/p\u003e","manuscriptTitle":"Effect of breastfeeding education and support provided to the male partner on optimal breastfeeding practice in southern Ethiopia: Study protocol of a cluster- randomized controlled trial","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-11-05 06:43:41","doi":"10.21203/rs.3.rs-3284805/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"e55616db-2264-42c4-b427-6ba44486040b","owner":[],"postedDate":"November 5th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2025-11-05T06:43:41+00:00","versionOfRecord":[],"versionCreatedAt":"2025-11-05 06:43:41","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-3284805","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-3284805","identity":"rs-3284805","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}