Meal replacement as a weight loss strategy for night shift workers with obesity: a protocol for a randomized controlled trial

Meal replacement as a weight loss strategy for night shift workers with obesity: a protocol for a 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 Research Article Meal replacement as a weight loss strategy for night shift workers with obesity: a protocol for a randomized controlled trial Piumika Sooriyaarachchi, Ranil Jayawardena, Toby Pavey, Neil King This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-1415732/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 6 You are reading this latest preprint version Abstract Background: Shift work is considered a risk factor for a number of chronic health conditions including obesity. Weight reduction in obese patients lowers the risk for cardiovascular disease, diabetes, certain cancers, and mortality. Achieving a negative energy balance by providing low-calorie meal replacements is widely used for weight management. This study aims to evaluate the impact of a low calorie “meal-replacement” on weight and metabolic parameters of shift workers with obesity. Methods: This trial will be conducted in parallel, randomized controlled design for a period of 8 weeks. A total of 44 shift workers with Body Mass Index over 25 kg/m 2 will be recruited after assessing eligibility. Participants will be randomly assigned to the test and control groups on a 1:1 ratio. The intervention group (N=22) will be provided with a low calorie (~200 kcal) meal replacement shake as a dinner, and the control group (N=22) will continue their habitual diets. The visits and the evaluations will be done as follows: screening (visit 0), 4 weeks (visit 1), and 8 weeks (visit 2). Anthropometric measurements will be taken at 0, 4 and 8 weeks. Body composition, biochemical parameters, dietary intake and physical activity will be assessed during the first and the last visit. Outcomes: The primary outcome will be body weight loss, and the proportion of participants that had a 5% body weight loss from baseline. The secondary outcomes will be post intervention changes in the other metabolic parameters. Discussion: To our knowledge this is one of the first randomized controlled trials evaluating the effects of a meal replacement as the night meal for weight loss in shift worker with obesity. Moreover, improvement of metabolic parameters in shift-workers will be an added benefit to this high risk group. Trial registration: Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12622000231741. Registered on 09 February 2022. https://www.anzctr.org.au/ACTRN12622000231741.aspx Shift work obesity weight loss meal replacement low-calorie Figures Figure 1 Introduction The prevalence of shift work is increasing in modern society to cater for the complexity and flexibility of many operations that exceed the duration of a normal work day. Shift work is defined as work performed mostly outside of typical working hours [ 1 ]. It has been considered as a major occupational hazard, and there is a plethora of research showing associations between shift work and chronic diseases [ 2 ]. Recent studies have shown that shift work was linked to an elevated risk of obesity, particularly abdominal obesity, with the risk being higher among long-term night shift workers [ 3 ]. Obesity is a major contributor to and risk factor for increased morbidity and mortality due to a variety of diseases [ 4 ]. Global obesity burden has doubled since 1980 and the World Health Organization (WHO) predicts that one out of every five persons will be obese by 2025 [ 5 ]. Obesity has increased significantly in all South Asian countries [ 6 ]. The prevalence of overweight and obesity has increased by almost 40% from 1990 to 2013 In Southeast Asian region [ 7 ]. The level of obesity in Sri Lanka has increased by several folds during the last two decades. According to Sri Lankan body mass index cut-off (BMI ≥ 25 kg/m 2 ), the prevalence of obesity in 2011 was 21.0% and 32.5% in men and women respectively [ 8 ]. In 2011, the obesity rates have been increased up to 44.6% in males and 56.3% in females [ 9 ]. Unhealthy dietary habits, low physical activity, sleep deprivation, and disruption of the circadian rhythm have been proposed as the potential causes underlying the weight gain among shift workers [ 10 ]. The sleep–wake cycle, thermogenesis, food intake, and lipids and glucose metabolism are reported to be influenced by circadian regulation [ 1 ]. Short sleep duration has been shown to lower leptin levels while increasing ghrelin levels, leading to an increase in appetite and weight gain [ 11 ]. In support of this view, several studies have shown that night shifts are associated with higher energy intake [ 12 ]. In addition, altered food habits also have a profound impact on peripheral circadian clock mechanisms [ 13 ]. Shift workers were found to consume more inflammatory diets than day workers, especially for dinner which creates a significant metabolic strain for the body (28). Shiftwork, and snacking during evening work in particular, is reported as common, with frequent sugar intake in the form of biscuits, soft drinks and sandwiches that are easy to obtain [ 14 ]. Therefore, raising awareness about the effects of shift work on unhealthy food habits, and prescribing evidence-based interventions, may help shift workers' health by preventing weight gain and associated metabolic consequences [ 15 ]. A loss of 5–10% of initial body weight is known to be effective in the treatment of many of the complications associated with obesity such as type 2 diabetes, hypertension, and hyperlipidemia [ 16 ]. Weight reduction is associated with increased performance and work capacity in obese individuals, thus contributing towards improving their quality of life [ 17 ]. Furthermore, following involvement in weight loss interventions, consistent significant increases in psychological indices such as self-esteem, depressive symptoms, body image, and health-related quality of life have been reported. [ 18 ] In comparison to standard energy deficit diets that simply prescribe a reduction in energy intake, evidence shows that meal replacement diets result in greater weight loss [ 19 ], better compliance [ 20 ] are more likely to provide appropriate intake of essential nutrients and have higher satisfaction and lower drop-out rates [ 21 ]. To the best of our knowledge, a dietary intervention with a low calorie meal replacement meal aimed to lose body weight and improve metabolic parameters has not been tested among night shift workers. Therefore, the present randomized controlled trail will be conducted to investigate the effectiveness of a low calorie meal replacement dinner compared to a traditional dinner meal on metabolic parameters of shift workers with obesity. Methods This protocol was written following the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Checklist (Additional file 1) [ 22 ]. The schedule of trial enrollment, interventions and assessments is presented in Table 1 . Table 1 Summarized study schedule at each visit in the clinical trial STUDY PERIOD Enrolment Allocation Post-allocation TIME POINT -t 1 (2 weeks) 0 Visit 1 (4 weeks) Visit 2 (8 weeks) ENROLMENT Eligibility screening × Informed consent × Allocation × INTERVENTIONS Meal replacement group × × No meal replacement group × × ASSESSMENTS FBG × × Serum HbA1c × × Lipid profile × × Blood pressure × × Anthropometric measures × × × Body composition measures × × FFQ/ IPAQ × × Objectives and hypothesis Hypothesis: Primary- prescribing a reduced caloric meal replacement at dinner will have beneficial effects on weight loss of night shift workers with obesity Secondary- associated metabolic parameters (lipid profile, glycemic outcomes and blood pressure) will be improved in the treatment group in comparison to the control group Objectives: Primary- to investigate if dinner meal replacement with a low calorie meal replacement shake is an effective strategy to achieve a minimum 5% body weight loss in shift workers with obesity compared to conventional dinner. Secondary- to evaluate the effects on anthropometric parameters, serum lipids, glycemic outcomes and blood pressure. Study design and setting This study will be conducted as a parallel, randomized controlled clinical trial at the Nawaloka Hospital PLC, Colombo, Sri Lanka, for a period of 8 weeks, evaluating the effect of a meal replacement for dinner in obese shift workers. Sample size A sample of 44 healthcare employees who engage in shift work will be recruited for the study after screening for eligibility against inclusion and exclusion criteria mentioned below. The minimum sample size will be calculated based on the primary outcome, the proportion of participants achieving 5%weight loss after 8 weeks. Previous weight loss intervention trials predicted that 50% of individuals in the intervention group and 10% of participants in the control group would lose at least 5% of their baseline body weight after 8 weeks. [23]. To detect this difference in the proportion of participants achieving 5%weight loss between the intervention and control groups, 17 participants were required in each group, to ensure 80% power at a 5% significance level. To accommodate a 20% dropout rate,we therefore needed to recruit 22 participants in each intervention group. Hence, a total of 44 adults with obesity (BMI > 25kg/m 2 ) will be recruited for the study [24]. The formula used for sample size calculation is presented below; n B = Sample size in one arm P A = Proportion of subjects expected to achieve 5% weight loss at the end of 8 weeks in placebo group (0.1) P B = Proportion of subjects expected to achieve 5% weight loss at the end of 8 weeks in treatment group (0.5) Κ = Sampling ratio (1:1) Z α = Critical value of the normal distribution at α (α is 0.05 and the critical value is 1.96) Z β = Critical value of the normal distribution at β (β is 0.2) Population The study population will consist of obese health care employees in rotating shift work who provides health care services, either directly (e.g. Doctors and nurses) or indirectly (e.g. helpers, laboratory technicians, medical waste handlers, security officers). Inclusion and exclusion criteria Inclusion criteria Permanent employees aged 18–65 years Have been working shifts continuously for the past 12 months and continue during the whole study period (8 weeks). Working at least 3 night shifts/week Participants with BMI ≥ 25 kg/m 2 Not having any allergies to any of the known food ingredients especially for milk and soya. Exclusion criteria Pregnant or lactating mothers Having known chronic disease conditions Having a known allergy history for milk or any of the ingredients in the meal replacement. History of any type of minor or major surgical procedure in the past 6 months. Currently on diet prescriptions or participating in regular physical activity sessions Suspension criteria Subject’s request to discontinue the study. Serious adverse events or unusual changes in clinical test results. Principal investigator’s decision to terminate the study (low compliance rate, complications or unable to continue the study due to various reasons). Randomization Participants satisfying the eligibility criteria will be allocated to control and intervention groups equally (1:1) using the simple random sampling technique. A computer-generated random numbers sequence would be used for randomization. Eligibility evaluation and enrolment will be conducted by one independent investigator, while randomization will be done by another investigator. Interventions The test group will be provided with a 200 kcal meal replacement shake consisting 20.0 g of protein, 4.5 g of fat, 18.2 g of carbohydrate and 3.6 g of fiber with other vitamins and minerals (supplementary table 1). The meal replacement will be in powdered form, and participants will be instructed to prepare the liquid shake by mixing 53 g of powdered meal replacement with 400 mL of water. They will be asked to consume one serving of the meal replacement shake to replace dinner for 5 days of the week for a period of 8 weeks. The intervention group will be given sufficient meal replacement tins with a label indicating the ingredients and the preparation method. Participants will be instructed not to consume any additional food in between dinner in the evening, and breakfast the following morning. The breakfast and lunch meals will be recommended as normal meals (the meals that they habitually eat). The control group will be asked to continue their usual dinner meals during the study period. In addition, both the groups will be given general dietary and lifestyle advice through distribution of leaflets which includes basic dietary advice according to Sri Lankan food based dietary guidelines. Both groups will be advised to continue their habitual physical activities. Study groups The treatment group will receive the meal replacement shake for their dinner. The control group will be advised to continue their routine dinner. Study period The study lasts for 8 weeks, and periodic measurements will take place at: screening (visit 0), 4 weeks (visit 1), 8 weeks (visit 2) (see Fig. 1). Primary outcome The primary outcome will be body weight loss, and the proportion of participants that had a 5% body weight loss from baseline Secondary outcomes Changes in waist circumference, hip circumference, percentage body fat and fat free mass. Change in systolic blood pressure and diastolic blood pressure. Change in lipid profile from baseline - total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL) and triglycerides. Changes in glycemic control measures from baseline- fasting blood sugar, glycated haemoglobin (HbA1c). Procedures Recruitment Healthcare employees of the Nawaloka Hospitals PLC, Colombo, Sri Lanka will be recruited on a voluntary basis for this study by advertising through notices and distribution of leaflets with study information. Informed written consent will be obtained from all study participants before recruitment. Study schedule Anthropometric measure, blood pressure, fasting plasma glucose, serum HbA1c and lipid profile will be measured at the time of recruitment of participants and will be repeated at the end of 8th week. However, anthropometry measures which will be again measured at the end of 4th week additionally. The details of items which will be measured at every visit are described in Table 1 . Measurement tools Anthropometric measurements Anthropometric measurements will be performed using calibrated equipment by trained personnel adhering to international recommendations. Height will be taken to the nearest 0.1 cm, as the maximum distance to the uppermost position on the head from heels, with the individual standing barefoot and in full inspiration using a calibrated stadiometer (Seca 213 portable stadiometer). Body weight will be measured to the nearest 0.1 kg using a calibrated digital weighing scale (Seca 813, Hamburg, Germany) with the participants wearing indoor light clothing and after emptying the bladder. Waist circumference will be measured midway between the iliac crest and the lower rib margin at the end of normal expiration using a plastic flexible tape to the nearest 0 .1 cm. Similarly, the hip circumference will be measured at the widest level over the greater trochanters level to the nearest 0 .1 cm. BMI will be calculated as body mass in kilograms divided by height in meters squared (kg/m 2 ) and waist-to-hip ratio by dividing measured waist by hip circumference. Body composition Resistance (R) and reactance (X) will be assessed by bio-electrical impedance analysis (BIA) using a commercial portable device (Bodystat 1500, Bodystat Ltd, Isle of Man, British Isles) with hand-to-foot single frequency measurement while the subject remained supine. The participants will be asked to lie in supine position, and then the electrodes of the BIA device will be placed on the right hand and foot. Metal objects will be removed from the body, and measurements will be taken at room temperature. To calculate fat free mass and BF%, the resistance and reactance values will be applied to an ethnic-specific prediction equation developed for Asians [ 25 ]. Dietary measurements A culturally validated Food Frequency Questionnaire (FFQ) will be used to obtain habitual intake of calories, macronutrients and micronutrients [ 26 ]. The energy content of each food component will be calculated using standard energy values for the portion sizes. The daily energy intakes are to be calculated using Nutri-Survey Software (EBISpro) modified with Sri Lankan food composition data. Physical activity Physical activity will be evaluated using the International Physical Activity Questionnaire (IPAQ) short version [ 27 ]. Biochemical analysis A venous blood sample of 10–12 mL will be collected from each participant after an overnight fasting. Blood glucose, total cholesterol, triglycerides, and HDL-cholesterol will be determined using a Cobas c501 auto analyzer using an electrochemiluminescent immunoassay (ECLIA, Roche Diagnostics). LDL-cholesterol will be determined using the Friedewald formula. HbA1c will be evaluated by ion-exchange high-performance liquid chromatography. Clinical examination Seated blood pressure will be recorded to on two occasions after at least a 10-min rest using a digital blood pressure monitors (Omron Healthcare, Singapore). Compliance calculation Powdered meal replacement will be dispensed to each participant at baseline, end of the 2nd, 4th and 6th weeks. Participants will be instructed to return any unused meal replacement powder to the investigator at the end of the study. Compliance will be evaluated using the following formula: Compliance % = \(\frac{\left(Distributed mealreplacement quantity–Remaining mealreplacement quantity\right)}{Distributed mealreplacement quantity}\times 100\) In addition, researchers will phone participants periodically to monitor the consumption of the meal replacement. Each participant will be asked to record the meal replacement intake on each day in a compliance assessment sheet provided at baseline. At each visit these consumption records will be cross-checked with subjects. WhatsApp ® groups will be created for communication with intervention and control groups. Statistical analysis Using SPSS version 23 (SPSS Inc., Chicago, IL, USA), parametric and non-parametric statistical tests will be applied for data analysis. Summary statistics of each group will be computed and presented as mean, standard deviation and proportion. Using a paired t-test, the baseline and end of study characteristics as well as the laboratory results of the groups will be compared and a P value of < 0.05 will be considered significant. Multiple regression analysis will be used to assess other factors influencing the weight change. Distributions of continuous variables will be tested for normality using the Kolmogorov-Smirnov test. The non-parametric Mann-Whitney U test will be used for asymmetrical continuous variables. Adverse effect evaluation The meal replacement provides one-third of the Recommended Daily Allowance (RDA) of micro nutrients in addition to 20 g of protein and sufficient amount of fiber. Therefore, micronutrient deficiencies are very unlikely to occur. Furthermore, all participants will be thoroughly screened for any history of allergic reactions, particularly to milk products and other ingredients in the product. However, in the event of a probable adverse reaction the following precautions would ensure timely identification and management of patients: Reporting—to monitor any potential adverse events, participants will have the opportunity to contact the researchers via WhatsApp ® , 24hr daily. During follow-up visits, adverse events will be noted by history and examination and investigated in detail. All adverse effects observed will be documented in the case report form. Management—in the event of an adverse reaction requiring in-hospital management, the facilities and expert management would be available at the Nawaloka Hospital PLC, Colombo, Sri Lanka. Termination of study—the complete clinical trial will be terminated prematurely if there is evidence that the safety of the trial participants can no longer be guaranteed, or new scientific information arises during course of the clinical trial regarding safety of the patients. Data collection Data collection will be performed according to the standard operating procedures (SOPs) by the principal investigator and trained research assistants. Data management and monitoring Storage: Data and documents will be locked and secured for 5 years, under the supervision of the principal investigator. Simultaneously, electronic copies will be stored in the Queensland University of Technology (QUT) Research Data Storage Service according to the QUT data management plan for the above prescribed period. Data will be entered by a minimum number of dedicated staff and saved in a dedicated computer with password protection. Samples will be stored in a secure facility, with measures taken to ensure that specimens are kept under correct and constant conditions at all times when in storage. Expert staff that are trained specifically in sample storage and transportation would ensure that all regulatory issues are properly handled. Dissemination of study finding The results of the above study will be disseminated as publications and presentations in national and international journals or scientific meetings. Ethical considerations The study protocol has been reviewed and approved by the Queensland University of Technology, Human Research Ethics Committee (UHREC approval no: 4878) and the institutional approval to conduct the study was taken from the Nawaloka Hospitals Research and Education Foundation, Colombo, Sri Lanka. The trial is also registered at the Australian New Zealand Clinical Trials Registry (ACTRN12622000231741). The study will be conducted in compliance with the Declaration of Helsinki and the good clinical practice guidelines. Any change in trial protocol will be notified to the relevant regulatory authorities and trial participants, with re-consent being taken from participants, if required. Discussion This manuscript describes the protocol for a clinical trial designed to evaluate the effects of having a low calorie meal replacement dinner compared to habitual dinner meal on metabolic parameters of shift workers with obesity. To our knowledge this is one of the first randomized controlled trials evaluating the effects of a low calorie meal replacement dinner in shift workers with obesity. The health sector is critical to any country's social and economic development. Therefore maintaining the wellbeing of healthcare employees is essential for improving the industry's quality, productivity, and profitability. Healthcare employees should be physically and of sound mental health, in order to provide constant attention to patients' requirements and ensure continuity of service in healthcare institutions. Most importantly, healthcare workers should be healthy role models for their patients. But, according to several studies, healthcare workers are no better than the general population when it comes to non-communicable diseases including obesity, diabetes, hypertension, as well as cardiovascular diseases [ 28 ]. Despite healthcare workers being well-informed about the causes and hazards of overweight and obesity, research in most countries have consistently indicated that they had a significantly greater risk of overweight, obesity and metabolic syndrome than the general population. The prevalence of overweight and obesity among health-care workers in Ghana ranged from 25.3–38.39% and 12.5–28.9% [ 29 ]. A study conducted in Botswana found that 34% of hospital employees had metabolic syndrome, 28.7% were obese, and 27.3% were overweight [ 30 ]. Another research of hospital employees found that late shift workers gained 4.3 kg more than day-shift workers (P = 0.02) after starting the current shift [ 31 ]. Habitual diet has great influence on the well-being of healthcare workers. However, most of the employees in this industry find it extremely difficult to have a balanced meal while coping with their workload, and demands of their work habits and associated lifestyle [ 32 ]. Several studies have shown an association between shift work and unhealthy eating habits, which could influence body composition and related health problems [ 33 ]. A study revealed that high energy density foods such as pastries, sweets, and sodas contributed to a significant portion of shift workers' daily energy intake, with 18.1%, 20.7%, and 21.6% accounting for morning, afternoon, and night shifts, respectively [ 34 ]. Also the shift schedules often affects meal times and meal patterns. According to recent research, the timing of food intake has a substantial impact on metabolism and weight management [ 35 ]. When planning appropriate nutritional interventions for night shift employees, it's also crucial to consider fatigue management and the unique requirements of night work [ 36 ], as food composition and meal distribution can have a significant impact on work performance and productivity [ 37 ]. In this study we selected a low-calorie meal replacement approach for shift workers with obesity as a weight loss strategy with the aim of improving behavioral compliance, increasing nutritional awareness, and its association with regular meals and less snacking [ 19 ]. Even in earlier research, participants who used meal replacements rated their dietary compliance and convenience higher than those who used traditional weight-loss regimens [ 38 ]. Therefore we believe that this would be a practical intervention to implement in the workplace. Given the current interest in adopting low calorie meal replacement meals to achieve weight loss in obese shift workers, no well-designed randomized control trials have been undertaken for a sufficient time period to support or disprove this notion. Hence, the findings of this study will provide an alternative weight-loss for obese shift workers to lose their body weight without disrupting their work routine. Further, the findings of the current study would be useful in formulation new policies and designing new worksite weight loss interventions for employees’ obesity. Trial Status This article is in accordance with the study protocol Study protocol version 2.0, dated 01 November 2021. Enrollment for the trial has not yet started. Abbreviations BIA: Bio-electrical impedance analysis; BMI: Body mass index ; ECLIA: Electrochemiluminescent immunoassay; FFQ: Food frequency questionnaire; HDL: High-density lipoprotein; IPAQ: International Physical Activity Questionnaire; LDL: Low-density lipoprotein; QUT: Queensland University of Technology; RDA: Recommended Daily Allowance; SOPs: Standard operating procedures; SPIRIT: Standard Protocol Items Recommendations for Interventional Trials; WHO: World Health Organization Declarations Ethics approval and consent to participate This study protocol has been approved by the Queensland University of Technology (QUT) Human Research Ethics Committee (UHREC approval no: 4878). All participants will sign a written informed consent form. Consent for publication Not applicable Availability of data and materials Not applicable. Competing interests The authors declare no conflict of interest regarding the publication of this paper Funding The authors declare that they received no funding for the conduction of this study Authors’ contributions PS and RJ substantially contributed to the general idea and design of the study. PS, RJ, NK, TP planned the data collection and analysis. PS drafted the manuscript. RJ, NK and TP revised the manuscript. All authors have read and consented to the manuscript. Acknowledgements None References Antunes LdC, Levandovski R, Dantas G, Caumo W, Hidalgo M. Obesity and shift work: chronobiological aspects. Nutr Res Rev. 2010;23(1):155–68. Zhang Q, Ying CS, Shan LSH, Pak-Chun CJ, Schwade M, Zhao X. Association between shift work and obesity among nurses: A systematic review and meta-analysis. Int J Nurs Stud. 2020:103757. Sun M, Feng W, Wang F, Li P, Li Z, Li M, et al. Meta-analysis on shift work and risks of specific obesity types. Obes Rev. 2018;19(1):28–40. 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Eating and shift work—effects on habits, metabolism, and performance. Scand J Work Environ Health. 2010:150–62. Phoi YY, Keogh JB. Dietary interventions for night shift workers: a literature review. Nutrients. 2019;11(10):2276. Noakes M, Foster PR, Keogh JB, Clifton PM. Meal replacements are as effective as structured weight-loss diets for treating obesity in adults with features of metabolic syndrome. J Nutr. 2004;134(8):1894–9. Supplementary Files SPIRITChecklist.doc supplementarytable1.docx Cite Share Download PDF Status: Under Review Version 1 posted Editorial decision: Major revision 16 Sep, 2022 Reviewers agreed at journal 26 Jul, 2022 Reviews received at journal 06 Apr, 2022 Reviewers invited by journal 06 Apr, 2022 Editor assigned by journal 06 Apr, 2022 First submitted to journal 03 Mar, 2022 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. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. 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-1415732","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":96478429,"identity":"ae9c8996-0ab3-4b38-90dc-8a07478de35a","order_by":0,"name":"Piumika Sooriyaarachchi","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA30lEQVRIiWNgGAWjYDACZiBOOABmMj4AEjx8pGhhNgBpYSPOKogWNgkwSUixOTuP6YYHZ+wY5Nubj1V+zbGTYWNgfvjoBh4tls08ZjcSbiQzGJw5lnZbdlsy0GFsxsY5eLQYHAZp+cDMYCCRY3ZbchszUAsPmzQRWuoZ5GfkmBVLbqsnVsuNwwwMN3LMGD9uO0xYi2UzW9mNhDPHeYB+SZZm3Hach42ZgF/M+Q9vu/njWLUcMMQOfvy5rdqen7354WO8DoPSPCCCGULiUY6sBQwYfxBQPQpGwSgYBSMTAABALkTnafz+gwAAAABJRU5ErkJggg==","orcid":"https://orcid.org/0000-0001-9570-2344","institution":"QUT: Queensland University of Technology","correspondingAuthor":true,"submittingAuthor":false,"prefix":"","firstName":"Piumika","middleName":"","lastName":"Sooriyaarachchi","suffix":""},{"id":96478430,"identity":"7d6f8b63-65b3-45ef-8f49-02b970c13736","order_by":1,"name":"Ranil Jayawardena","email":"","orcid":"","institution":"University of Colombo Faculty of Medicine","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Ranil","middleName":"","lastName":"Jayawardena","suffix":""},{"id":96478431,"identity":"5bae55a5-251c-4c10-a282-4ad44a6c1f6b","order_by":2,"name":"Toby Pavey","email":"","orcid":"","institution":"Queensland University of Technology - Kelvin Grove Campus","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Toby","middleName":"","lastName":"Pavey","suffix":""},{"id":96478432,"identity":"9eaa5435-d823-4fc2-a248-29340db9f43c","order_by":3,"name":"Neil King","email":"","orcid":"","institution":"QUT IHBI RMG: Queensland University of Technology Institute of Health and Biomedical Innovation","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Neil","middleName":"","lastName":"King","suffix":""}],"badges":[],"createdAt":"2022-03-03 13:42:57","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-1415732/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-1415732/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":20117964,"identity":"41595ffd-c89c-4db3-8f7b-70db11ad156d","added_by":"auto","created_at":"2022-04-08 14:18:25","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":82963,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eCONSORT flow diagram\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"fig1.png","url":"https://assets-eu.researchsquare.com/files/rs-1415732/v1/6346979eb033c115e72596b2.png"},{"id":20117966,"identity":"235671e9-7b02-4b91-b13b-b49470658a80","added_by":"auto","created_at":"2022-04-08 14:18:28","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":543878,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-1415732/v1/aa4970ab-4a75-4246-8b19-f8e6b81611a9.pdf"},{"id":20117216,"identity":"93e79984-e534-4674-9b82-1daea12f3971","added_by":"auto","created_at":"2022-04-08 14:13:25","extension":"doc","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":123904,"visible":true,"origin":"","legend":"","description":"","filename":"SPIRITChecklist.doc","url":"https://assets-eu.researchsquare.com/files/rs-1415732/v1/8690b817a3462783ae01fd4d.doc"},{"id":20117965,"identity":"1aaf4f67-075b-4f1b-9042-8ada2bd69a98","added_by":"auto","created_at":"2022-04-08 14:18:25","extension":"docx","order_by":2,"title":"","display":"","copyAsset":false,"role":"supplement","size":13563,"visible":true,"origin":"","legend":"","description":"","filename":"supplementarytable1.docx","url":"https://assets-eu.researchsquare.com/files/rs-1415732/v1/41615148290f4c489a53f641.docx"}],"financialInterests":"","formattedTitle":"Meal replacement as a weight loss strategy for night shift workers with obesity: a protocol for a randomized controlled trial","fulltext":[{"header":"Introduction","content":"\u003cp\u003eThe prevalence of shift work is increasing in modern society to cater for the complexity and flexibility of many operations that exceed the duration of a normal work day. Shift work is defined as work performed mostly outside of typical working hours [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. It has been considered as a major occupational hazard, and there is a plethora of research showing associations between shift work and chronic diseases [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]. Recent studies have shown that shift work was linked to an elevated risk of obesity, particularly abdominal obesity, with the risk being higher among long-term night shift workers [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eObesity is a major contributor to and risk factor for increased morbidity and mortality due to a variety of diseases [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]. Global obesity burden has doubled since 1980 and the World Health Organization (WHO) predicts that one out of every five persons will be obese by 2025 [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]. Obesity has increased significantly in all South Asian countries [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]. The prevalence of overweight and obesity has increased by almost 40% from 1990 to 2013 In Southeast Asian region [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e]. The level of obesity in Sri Lanka has increased by several folds during the last two decades. According to Sri Lankan body mass index cut-off (BMI\u0026thinsp;\u0026ge;\u0026thinsp;25 kg/m\u003csup\u003e2\u003c/sup\u003e), the prevalence of obesity in 2011 was 21.0% and 32.5% in men and women respectively [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]. In 2011, the obesity rates have been increased up to 44.6% in males and 56.3% in females [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eUnhealthy dietary habits, low physical activity, sleep deprivation, and disruption of the circadian rhythm have been proposed as the potential causes underlying the weight gain among shift workers [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]. The sleep\u0026ndash;wake cycle, thermogenesis, food intake, and lipids and glucose metabolism are reported to be influenced by circadian regulation [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. Short sleep duration has been shown to lower leptin levels while increasing ghrelin levels, leading to an increase in appetite and weight gain [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]. In support of this view, several studies have shown that night shifts are associated with higher energy intake [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eIn addition, altered food habits also have a profound impact on peripheral circadian clock mechanisms [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]. Shift workers were found to consume more inflammatory diets than day workers, especially for dinner which creates a significant metabolic strain for the body (28). Shiftwork, and snacking during evening work in particular, is reported as common, with frequent sugar intake in the form of biscuits, soft drinks and sandwiches that are easy to obtain [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e]. Therefore, raising awareness about the effects of shift work on unhealthy food habits, and prescribing evidence-based interventions, may help shift workers' health by preventing weight gain and associated metabolic consequences [\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eA loss of 5\u0026ndash;10% of initial body weight is known to be effective in the treatment of many of the complications associated with obesity such as type 2 diabetes, hypertension, and hyperlipidemia [\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e]. Weight reduction is associated with increased performance and work capacity in obese individuals, thus contributing towards improving their quality of life [\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e]. Furthermore, following involvement in weight loss interventions, consistent significant increases in psychological indices such as self-esteem, depressive symptoms, body image, and health-related quality of life have been reported. [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]\u003c/p\u003e \u003cp\u003eIn comparison to standard energy deficit diets that simply prescribe a reduction in energy intake, evidence shows that meal replacement diets result in greater weight loss [\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e], better compliance [\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e] are more likely to provide appropriate intake of essential nutrients and have higher satisfaction and lower drop-out rates [\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e]. To the best of our knowledge, a dietary intervention with a low calorie meal replacement meal aimed to lose body weight and improve metabolic parameters has not been tested among night shift workers. Therefore, the present randomized controlled trail will be conducted to investigate the effectiveness of a low calorie meal replacement dinner compared to a traditional dinner meal on metabolic parameters of shift workers with obesity.\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003eThis protocol was written following the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Checklist (Additional file 1) [\u003cspan class=\"CitationRef\"\u003e22\u003c/span\u003e]. The schedule of trial enrollment, interventions and assessments is presented in Table \u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e.\u003c/p\u003e\n\u003ctable border=\"1\" id=\"Tab1\"\u003e\n \u003ccaption language=\"En\"\u003e\n \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e\n \u003cdiv class=\"CaptionContent\"\u003e\n \u003cp\u003eSummarized study schedule at each visit in the clinical trial\u003c/p\u003e\n \u003c/div\u003e\n \u003c/caption\u003e\n \u003cthead\u003e\n \u003ctr\u003e\n \u003cth align=\"left\"\u003e\u0026nbsp;\u003c/th\u003e\n \u003cth align=\"left\" colspan=\"4\"\u003e\n \u003cp\u003eSTUDY PERIOD\u003c/p\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003c/thead\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eEnrolment\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eAllocation\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\" colspan=\"2\"\u003e\n \u003cp\u003e\u003cstrong\u003ePost-allocation\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eTIME POINT\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e-t\u003csub\u003e1\u003c/sub\u003e\u003c/p\u003e\n \u003cp\u003e(2 weeks)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eVisit 1\u003c/p\u003e\n \u003cp\u003e(4 weeks)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eVisit 2\u003c/p\u003e\n \u003cp\u003e(8 weeks)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eENROLMENT\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eEligibility screening\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026times;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eInformed consent\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026times;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eAllocation\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026times;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eINTERVENTIONS\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eMeal replacement group\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026times;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026times;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eNo meal replacement group\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026times;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026times;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eASSESSMENTS\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eFBG\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026times;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026times;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eSerum HbA1c\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026times;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026times;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eLipid profile\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026times;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026times;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eBlood pressure\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026times;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026times;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eAnthropometric measures\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026times;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026times;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026times;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eBody composition measures\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026times;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026times;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eFFQ/ IPAQ\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026times;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026times;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cdiv class=\"Section2\" id=\"Sec3\"\u003e\n \u003ch2\u003eObjectives and hypothesis\u003c/h2\u003e\n \u003cp\u003e\u003cstrong\u003eHypothesis:\u003c/strong\u003e\u003c/p\u003e\n \u003cul\u003e\n \u003cli\u003ePrimary- prescribing a reduced caloric meal replacement at dinner will have beneficial effects on weight loss of night shift workers with obesity\u003c/li\u003e\n \u003cli\u003e\n \u003cp\u003eSecondary- associated metabolic parameters (lipid profile, glycemic outcomes and blood pressure) will be improved in the treatment group in comparison to the control group\u003c/p\u003e \u003c/li\u003e\n \u003c/ul\u003e\n \u003cp\u003eObjectives:\u003c/p\u003e\n \u003cul\u003e\n \u003cli\u003e\n \u003cp\u003ePrimary- to investigate if dinner meal replacement with a low calorie meal replacement shake is an effective strategy to achieve a minimum 5% body weight loss in shift workers with obesity compared to conventional dinner.\u003c/p\u003e\n \u003c/li\u003e\n \u003cli\u003e\n \u003cp\u003eSecondary- to evaluate the effects on anthropometric parameters, serum lipids, glycemic outcomes and blood pressure.\u003c/p\u003e\n \u003c/li\u003e\n \u003c/ul\u003e\n\u003c/div\u003e\n\u003cdiv class=\"Section2\" id=\"Sec4\"\u003e\n \u003ch2\u003eStudy design and setting\u003c/h2\u003e\n \u003cp\u003eThis study will be conducted as a parallel, randomized controlled clinical trial at the Nawaloka Hospital PLC, Colombo, Sri Lanka, for a period of 8 weeks, evaluating the effect of a meal replacement for dinner in obese shift workers.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv class=\"Section2\" id=\"Sec5\"\u003e\n \u003ch2\u003eSample size\u003c/h2\u003e\n \u003cp\u003eA sample of 44 healthcare employees who engage in shift work will be recruited for the study after screening for eligibility against inclusion and exclusion criteria mentioned below. The minimum sample size will be calculated based on the primary outcome, the proportion of participants achieving 5%weight loss after 8 weeks. Previous weight loss intervention trials predicted that 50% of individuals in the intervention group and 10% of participants in the control group would lose at least 5% of their baseline body weight after 8 weeks. [23]. To detect this difference in the proportion of participants achieving 5%weight loss between the intervention and control groups, 17 participants were required in each group, to ensure 80% power at a 5% significance level. To accommodate a 20% dropout rate,we therefore needed to recruit 22 participants in each intervention group. Hence, a total of 44 adults with obesity (BMI\u0026thinsp;\u0026gt;\u0026thinsp;25kg/m\u003csup\u003e2\u003c/sup\u003e) will be recruited for the study [24]. The formula used for sample size calculation is presented below;\u003c/p\u003e\n \u003cp\u003e\u003cimg 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\"\u003e\u003c/p\u003e\n \u003cp\u003en\u003csub\u003eB\u003c/sub\u003e = Sample size in one arm\u003c/p\u003e\n \u003cp\u003eP\u003csub\u003eA\u003c/sub\u003e = Proportion of subjects expected to achieve 5% weight loss at the end of 8 weeks in placebo group (0.1)\u003c/p\u003e\n \u003cp\u003eP\u003csub\u003eB\u003c/sub\u003e = Proportion of subjects expected to achieve 5% weight loss at the end of 8 weeks in treatment group (0.5)\u003c/p\u003e\n \u003cp\u003e\u0026Kappa;\u0026thinsp;=\u0026thinsp;Sampling ratio (1:1)\u003c/p\u003e\n \u003cp\u003eZ\u003csub\u003e\u0026alpha;\u003c/sub\u003e = Critical value of the normal distribution at \u0026alpha; (\u0026alpha; is 0.05 and the critical value is 1.96)\u003c/p\u003e\n \u003cp\u003eZ\u003csub\u003e\u0026beta;\u003c/sub\u003e = Critical value of the normal distribution at \u0026beta; (\u0026beta; is 0.2)\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv class=\"Section2\" id=\"Sec6\"\u003e\n \u003ch2\u003ePopulation\u003c/h2\u003e\n \u003cp\u003eThe study population will consist of obese health care employees in rotating shift work who provides health care services, either directly (e.g. Doctors and nurses) or indirectly (e.g. helpers, laboratory technicians, medical waste handlers, security officers).\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv class=\"Section2\" id=\"Sec7\"\u003e\n \u003ch2\u003eInclusion and exclusion criteria\u003c/h2\u003e\n\u003c/div\u003e\n\u003cp\u003e\u003cstrong\u003eInclusion criteria\u003c/strong\u003e\u003c/p\u003e\n\u003col style=\"list-style-type: lower-alpha;\"\u003e\n \u003cli\u003e\n \u003cp\u003ePermanent employees aged 18\u0026ndash;65 years\u003c/p\u003e\n \u003c/li\u003e\n \u003cli\u003e\n \u003cp\u003eHave been working shifts continuously for the past 12 months and continue during the whole study period (8 weeks).\u003c/p\u003e\n \u003c/li\u003e\n \u003cli\u003e\n \u003cp\u003eWorking at least 3 night shifts/week\u003c/p\u003e\n \u003c/li\u003e\n \u003cli\u003e\n \u003cp\u003eParticipants with BMI\u0026thinsp;\u0026ge;\u0026thinsp;25 kg/m\u003csup\u003e2\u003c/sup\u003e\u003c/p\u003e\n \u003c/li\u003e\n \u003cli\u003e\n \u003cp\u003eNot having any allergies to any of the known food ingredients especially for milk and soya.\u003c/p\u003e\n \u003c/li\u003e\n\u003c/ol\u003e\n\u003cp\u003e\u003cstrong\u003eExclusion criteria\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003col style=\"list-style-type: lower-alpha;\"\u003e\n \u003cli\u003e\n \u003cp\u003ePregnant or lactating mothers\u003c/p\u003e\n \u003c/li\u003e\n \u003cli\u003e\n \u003cp\u003eHaving known chronic disease conditions\u003c/p\u003e\n \u003c/li\u003e\n \u003cli\u003e\n \u003cp\u003eHaving a known allergy history for milk or any of the ingredients in the meal replacement.\u003c/p\u003e\n \u003c/li\u003e\n \u003cli\u003e\n \u003cp\u003eHistory of any type of minor or major surgical procedure in the past 6 months.\u003c/p\u003e\n \u003c/li\u003e\n \u003cli\u003e\n \u003cp\u003eCurrently on diet prescriptions or participating in regular physical activity sessions\u003c/p\u003e\n \u003c/li\u003e\n\u003c/ol\u003e\n\u003cp\u003e\u003cstrong\u003eSuspension criteria\u003c/strong\u003e\u003c/p\u003e\n\u003col style=\"list-style-type: lower-alpha;\"\u003e\n \u003cli\u003e\n \u003cp\u003eSubject\u0026rsquo;s request to discontinue the study.\u003c/p\u003e\n \u003c/li\u003e\n \u003cli\u003e\n \u003cp\u003eSerious adverse events or unusual changes in clinical test results.\u003c/p\u003e\n \u003c/li\u003e\n \u003cli\u003e\n \u003cp\u003ePrincipal investigator\u0026rsquo;s decision to terminate the study (low compliance rate, complications or unable to continue the study due to various reasons).\u003c/p\u003e\n \u003c/li\u003e\n\u003c/ol\u003e\n\u003cp\u003e\u003cstrong\u003eRandomization\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eParticipants satisfying the eligibility criteria will be allocated to control and intervention groups equally (1:1) using the simple random sampling technique. A computer-generated random numbers sequence would be used for randomization. Eligibility evaluation and enrolment will be conducted by one independent investigator, while randomization will be done by another investigator.\u003c/p\u003e\n\u003cdiv class=\"Section2\" id=\"Sec12\"\u003e\n \u003cp\u003e\u003cstrong\u003eInterventions\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003eThe test group will be provided with a 200 kcal meal replacement shake consisting 20.0 g of protein, 4.5 g of fat, 18.2 g of carbohydrate and 3.6 g of fiber with other vitamins and minerals (supplementary table 1). The meal replacement will be in powdered form, and participants will be instructed to prepare the liquid shake by mixing 53 g of powdered meal replacement with 400 mL of water. They will be asked to consume one serving of the meal replacement shake to replace dinner for 5 days of the week for a period of 8 weeks. The intervention group will be given sufficient meal replacement tins with a label indicating the ingredients and the preparation method. Participants will be instructed not to consume any additional food in between dinner in the evening, and breakfast the following morning. The breakfast and lunch meals will be recommended as normal meals (the meals that they habitually eat).\u003c/p\u003e\n \u003cp\u003eThe control group will be asked to continue their usual dinner meals during the study period. In addition, both the groups will be given general dietary and lifestyle advice through distribution of leaflets which includes basic dietary advice according to Sri Lankan food based dietary guidelines. Both groups will be advised to continue their habitual physical activities.\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003eStudy groups\u003c/strong\u003e\u003c/p\u003e\n\u003c/div\u003e\n\u003cp\u003eThe treatment group will receive the meal replacement shake for their dinner. The control group will be advised to continue their routine dinner.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStudy period\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe study lasts for 8 weeks, and periodic measurements will take place at: screening (visit 0), 4 weeks (visit 1), 8 weeks (visit 2) (see Fig.\u0026nbsp;1).\u003c/p\u003e\n\u003cdiv class=\"Section2\" id=\"Sec15\"\u003e\n \u003ch2\u003ePrimary outcome\u003c/h2\u003e\n \u003cp\u003eThe primary outcome will be body weight loss, and the proportion of participants that had a 5% body weight loss from baseline\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv class=\"Section2\" id=\"Sec16\"\u003e\n\u003ch2\u003eSecondary outcomes\u003c/h2\u003e\n\u003col\u003e\n \u003cli\u003e\n \u003cp\u003eChanges in waist circumference, hip circumference, percentage body fat and fat free mass.\u003c/p\u003e\n \u003c/li\u003e\n \u003cli\u003e\n \u003cp\u003eChange in systolic blood pressure and diastolic blood pressure.\u003c/p\u003e\n \u003c/li\u003e\n \u003cli\u003e\n \u003cp\u003eChange in lipid profile from baseline - total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL) and triglycerides.\u003c/p\u003e\n \u003c/li\u003e\n \u003cli\u003e\n \u003cp\u003eChanges in glycemic control measures from baseline- fasting blood sugar, glycated haemoglobin (HbA1c).\u003c/p\u003e\n \u003c/li\u003e\n \u003c/ol\u003e\n \u003c/div\u003e\n\u003cdiv class=\"Section2\" id=\"Sec17\"\u003e\n \u003ch2\u003eProcedures\u003c/h2\u003e\n \u003cdiv class=\"Section3\" id=\"Sec18\"\u003e\n \u003ch2\u003eRecruitment\u003c/h2\u003e\n \u003cp\u003eHealthcare employees of the Nawaloka Hospitals PLC, Colombo, Sri Lanka will be recruited on a voluntary basis for this study by advertising through notices and distribution of leaflets with study information. Informed written consent will be obtained from all study participants before recruitment.\u003c/p\u003e\n \u003c/div\u003e\n\u003c/div\u003e\n\u003cdiv class=\"Section2\" id=\"Sec19\"\u003e\n \u003ch2\u003eStudy schedule\u003c/h2\u003e\n \u003cp\u003eAnthropometric measure, blood pressure, fasting plasma glucose, serum HbA1c and lipid profile will be measured at the time of recruitment of participants and will be repeated at the end of 8th week. However, anthropometry measures which will be again measured at the end of 4th week additionally. The details of items which will be measured at every visit are described in Table\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv class=\"Section2\" id=\"Sec20\"\u003e\n \u003ch2\u003eMeasurement tools\u003c/h2\u003e\n \u003cdiv class=\"Section3\" id=\"Sec21\"\u003e\n \u003ch2\u003eAnthropometric measurements\u003c/h2\u003e\n \u003cp\u003eAnthropometric measurements will be performed using calibrated equipment by trained personnel adhering to international recommendations. Height will be taken to the nearest 0.1 cm, as the maximum distance to the uppermost position on the head from heels, with the individual standing barefoot and in full inspiration using a calibrated stadiometer (Seca 213 portable stadiometer). Body weight will be measured to the nearest 0.1 kg using a calibrated digital weighing scale (Seca 813, Hamburg, Germany) with the participants wearing indoor light clothing and after emptying the bladder. Waist circumference will be measured midway between the iliac crest and the lower rib margin at the end of normal expiration using a plastic flexible tape to the nearest 0 .1 cm. Similarly, the hip circumference will be measured at the widest level over the greater trochanters level to the nearest 0 .1 cm. BMI will be calculated as body mass in kilograms divided by height in meters squared (kg/m\u003csup\u003e2\u003c/sup\u003e) and waist-to-hip ratio by dividing measured waist by hip circumference.\u003c/p\u003e\n \u003c/div\u003e\n\u003c/div\u003e\n\u003cp\u003e\u003cstrong\u003eBody composition\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eResistance (R) and reactance (X) will be assessed by bio-electrical impedance analysis (BIA) using a commercial portable device (Bodystat 1500, Bodystat Ltd, Isle of Man, British Isles) with hand-to-foot single frequency measurement while the subject remained supine. The participants will be asked to lie in supine position, and then the electrodes of the BIA device will be placed on the right hand and foot. Metal objects will be removed from the body, and measurements will be taken at room temperature. To calculate fat free mass and BF%, the resistance and reactance values will be applied to an ethnic-specific prediction equation developed for Asians [\u003cspan class=\"CitationRef\"\u003e25\u003c/span\u003e].\u003c/p\u003e\n\u003cdiv class=\"Section2\" id=\"Sec23\"\u003e\n \u003ch2\u003eDietary measurements\u003c/h2\u003e\n \u003cp\u003eA culturally validated Food Frequency Questionnaire (FFQ) will be used to obtain habitual intake of calories, macronutrients and micronutrients [\u003cspan class=\"CitationRef\"\u003e26\u003c/span\u003e]. The energy content of each food component will be calculated using standard energy values for the portion sizes. The daily energy intakes are to be calculated using Nutri-Survey Software (EBISpro) modified with Sri Lankan food composition data.\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003ePhysical activity\u003c/strong\u003e\u003c/p\u003e\n\u003c/div\u003e\n\u003cp\u003ePhysical activity will be evaluated using the International Physical Activity Questionnaire (IPAQ) short version [\u003cspan class=\"CitationRef\"\u003e27\u003c/span\u003e].\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eBiochemical analysis\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eA venous blood sample of 10\u0026ndash;12 mL will be collected from each participant after an overnight fasting. Blood glucose, total cholesterol, triglycerides, and HDL-cholesterol will be determined using a Cobas c501 auto analyzer using an electrochemiluminescent immunoassay (ECLIA, Roche Diagnostics). LDL-cholesterol will be determined using the Friedewald formula. HbA1c will be evaluated by ion-exchange high-performance liquid chromatography.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eClinical examination\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eSeated blood pressure will be recorded to on two occasions after at least a 10-min rest using a digital blood pressure monitors (Omron Healthcare, Singapore).\u003c/p\u003e\n\u003cdiv class=\"Section2\" id=\"Sec27\"\u003e\n \u003ch2\u003eCompliance calculation\u003c/h2\u003e\n \u003cp\u003ePowdered meal replacement will be dispensed to each participant at baseline, end of the 2nd, 4th and 6th weeks. Participants will be instructed to return any unused meal replacement powder to the investigator at the end of the study. Compliance will be evaluated using the following formula:\u003c/p\u003e\n \u003cp\u003eCompliance % =\u003cspan class=\"InlineEquation\"\u003e\u003cspan class=\"mathinline\"\u003e\\(\\frac{\\left(Distributed mealreplacement quantity\u0026ndash;Remaining mealreplacement quantity\\right)}{Distributed mealreplacement quantity}\\times 100\\)\u003c/span\u003e\u003c/span\u003e\u003c/p\u003e\n \u003cp\u003eIn addition, researchers will phone participants periodically to monitor the consumption of the meal replacement. Each participant will be asked to record the meal replacement intake on each day in a compliance assessment sheet provided at baseline. At each visit these consumption records will be cross-checked with subjects. WhatsApp\u003csup\u003e\u0026reg;\u003c/sup\u003e groups will be created for communication with intervention and control groups.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv class=\"Section2\" id=\"Sec28\"\u003e\n \u003ch2\u003eStatistical analysis\u003c/h2\u003e\n \u003cp\u003eUsing SPSS version 23 (SPSS Inc., Chicago, IL, USA), parametric and non-parametric statistical tests will be applied for data analysis. Summary statistics of each group will be computed and presented as mean, standard deviation and proportion. Using a paired t-test, the baseline and end of study characteristics as well as the laboratory results of the groups will be compared and a P value of \u0026lt;\u0026thinsp;0.05 will be considered significant. Multiple regression analysis will be used to assess other factors influencing the weight change. Distributions of continuous variables will be tested for normality using the Kolmogorov-Smirnov test. The non-parametric Mann-Whitney U test will be used for asymmetrical continuous variables.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv class=\"Section2\" id=\"Sec29\"\u003e\n \u003ch2\u003eAdverse effect evaluation\u003c/h2\u003e\n \u003cp\u003eThe meal replacement provides one-third of the Recommended Daily Allowance (RDA) of micro nutrients in addition to 20 g of protein and sufficient amount of fiber. Therefore, micronutrient deficiencies are very unlikely to occur. Furthermore, all participants will be thoroughly screened for any history of allergic reactions, particularly to milk products and other ingredients in the product. However, in the event of a probable adverse reaction the following precautions would ensure timely identification and management of patients:\u003c/p\u003e\n \u003col style=\"list-style-type: lower-alpha;\"\u003e\n \u003cli\u003e\n \u003cp\u003eReporting\u0026mdash;to monitor any potential adverse events, participants will have the opportunity to contact the researchers via WhatsApp\u003csup\u003e\u0026reg;\u003c/sup\u003e, 24hr daily.\u003c/p\u003e\n \u003c/li\u003e\n \u003cli\u003e\n \u003cp\u003eDuring follow-up visits, adverse events will be noted by history and examination and investigated in detail. All adverse effects observed will be documented in the case report form.\u003c/p\u003e\n \u003c/li\u003e\n \u003cli\u003e\n \u003cp\u003eManagement\u0026mdash;in the event of an adverse reaction requiring in-hospital management, the facilities and expert management would be available at the Nawaloka Hospital PLC, Colombo, Sri Lanka.\u003c/p\u003e\n \u003c/li\u003e\n \u003cli\u003e\n \u003cp\u003eTermination of study\u0026mdash;the complete clinical trial will be terminated prematurely if there is evidence that the safety of the trial participants can no longer be guaranteed, or new scientific information arises during course of the clinical trial regarding safety of the patients.\u003c/p\u003e\n \u003c/li\u003e\n \u003c/ol\u003e\n\u003c/div\u003e\n\u003cdiv class=\"Section2\" id=\"Sec30\"\u003e\n \u003ch2\u003eData collection\u003c/h2\u003e\n \u003cp\u003eData collection will be performed according to the standard operating procedures (SOPs) by the principal investigator and trained research assistants.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv class=\"Section2\" id=\"Sec31\"\u003e\n \u003ch2\u003eData management and monitoring\u003c/h2\u003e\n \u003cp\u003e\u003cstrong\u003eStorage:\u0026nbsp;\u003c/strong\u003eData and documents will be locked and secured for 5 years, under the supervision of the principal investigator. Simultaneously, electronic copies will be stored in the Queensland University of Technology (QUT) Research Data Storage Service according to the QUT data management plan for the above prescribed period. Data will be entered by a minimum number of dedicated staff and saved in a dedicated computer with password protection. Samples will be stored in a secure facility, with measures taken to ensure that specimens are kept under correct and constant conditions at all times when in storage. Expert staff that are trained specifically in sample storage and transportation would ensure that all regulatory issues are properly handled.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv class=\"Section2\" id=\"Sec32\"\u003e\n \u003ch2\u003eDissemination of study finding\u003c/h2\u003e\n \u003cp\u003eThe results of the above study will be disseminated as publications and presentations in national and international journals or scientific meetings.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv class=\"Section2\" id=\"Sec33\"\u003e\n \u003ch2\u003eEthical considerations\u003c/h2\u003e\n \u003cp\u003eThe study protocol has been reviewed and approved by the Queensland University of Technology, Human Research Ethics Committee (UHREC approval no: 4878) and the institutional approval to conduct the study was taken from the Nawaloka Hospitals Research and Education Foundation, Colombo, Sri Lanka. The trial is also registered at the Australian New Zealand Clinical Trials Registry (ACTRN12622000231741). The study will be conducted in compliance with the Declaration of Helsinki and the good clinical practice guidelines. Any change in trial protocol will be notified to the relevant regulatory authorities and trial participants, with re-consent being taken from participants, if required.\u003c/p\u003e\n\u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eThis manuscript describes the protocol for a clinical trial designed to evaluate the effects of having a low calorie meal replacement dinner compared to habitual dinner meal on metabolic parameters of shift workers with obesity. To our knowledge this is one of the first randomized controlled trials evaluating the effects of a low calorie meal replacement dinner in shift workers with obesity.\u003c/p\u003e \u003cp\u003eThe health sector is critical to any country's social and economic development. Therefore maintaining the wellbeing of healthcare employees is essential for improving the industry's quality, productivity, and profitability. Healthcare employees should be physically and of sound mental health, in order to provide constant attention to patients' requirements and ensure continuity of service in healthcare institutions. Most importantly, healthcare workers should be healthy role models for their patients. But, according to several studies, healthcare workers are no better than the general population when it comes to non-communicable diseases including obesity, diabetes, hypertension, as well as cardiovascular diseases [\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eDespite healthcare workers being well-informed about the causes and hazards of overweight and obesity, research in most countries have consistently indicated that they had a significantly greater risk of overweight, obesity and metabolic syndrome than the general population. The prevalence of overweight and obesity among health-care workers in Ghana ranged from 25.3\u0026ndash;38.39% and 12.5\u0026ndash;28.9% [\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e]. A study conducted in Botswana found that 34% of hospital employees had metabolic syndrome, 28.7% were obese, and 27.3% were overweight [\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e]. Another research of hospital employees found that late shift workers gained 4.3 kg more than day-shift workers (P\u0026thinsp;=\u0026thinsp;0.02) after starting the current shift [\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eHabitual diet has great influence on the well-being of healthcare workers. However, most of the employees in this industry find it extremely difficult to have a balanced meal while coping with their workload, and demands of their work habits and associated lifestyle [\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e]. Several studies have shown an association between shift work and unhealthy eating habits, which could influence body composition and related health problems [\u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e]. A study revealed that high energy density foods such as pastries, sweets, and sodas contributed to a significant portion of shift workers' daily energy intake, with 18.1%, 20.7%, and 21.6% accounting for morning, afternoon, and night shifts, respectively [\u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e]. Also the shift schedules often affects meal times and meal patterns. According to recent research, the timing of food intake has a substantial impact on metabolism and weight management [\u003cspan citationid=\"CR35\" class=\"CitationRef\"\u003e35\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eWhen planning appropriate nutritional interventions for night shift employees, it's also crucial to consider fatigue management and the unique requirements of night work [\u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e36\u003c/span\u003e], as food composition and meal distribution can have a significant impact on work performance and productivity [\u003cspan citationid=\"CR37\" class=\"CitationRef\"\u003e37\u003c/span\u003e]. In this study we selected a low-calorie meal replacement approach for shift workers with obesity as a weight loss strategy with the aim of improving behavioral compliance, increasing nutritional awareness, and its association with regular meals and less snacking [\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e]. Even in earlier research, participants who used meal replacements rated their dietary compliance and convenience higher than those who used traditional weight-loss regimens [\u003cspan citationid=\"CR38\" class=\"CitationRef\"\u003e38\u003c/span\u003e]. Therefore we believe that this would be a practical intervention to implement in the workplace.\u003c/p\u003e \u003cp\u003eGiven the current interest in adopting low calorie meal replacement meals to achieve weight loss in obese shift workers, no well-designed randomized control trials have been undertaken for a sufficient time period to support or disprove this notion. Hence, the findings of this study will provide an alternative weight-loss for obese shift workers to lose their body weight without disrupting their work routine. Further, the findings of the current study would be useful in formulation new policies and designing new worksite weight loss interventions for employees\u0026rsquo; obesity.\u003c/p\u003e"},{"header":"Trial Status","content":"\u003cp\u003eThis article is in accordance with the study protocol Study protocol version 2.0, dated 01 November 2021. Enrollment for the trial has not yet started.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003eBIA: Bio-electrical impedance analysis; BMI: Body mass index ; ECLIA: Electrochemiluminescent immunoassay; FFQ: Food frequency questionnaire; HDL: High-density lipoprotein; IPAQ: International Physical Activity Questionnaire; LDL: Low-density lipoprotein; QUT: Queensland University of Technology; RDA: Recommended Daily Allowance; SOPs: Standard operating procedures; SPIRIT: Standard Protocol Items Recommendations for Interventional Trials; WHO: World Health Organization \u0026nbsp;\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study protocol has been approved by the Queensland University of Technology (QUT) Human Research Ethics Committee (UHREC approval no:\u0026nbsp;4878).\u0026nbsp;All participants will sign a written informed consent form.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests\u003c/strong\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare no conflict of interest\u0026nbsp;regarding the publication of this paper\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare that they received no funding for the conduction of this study\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors\u0026rsquo; contributions\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ePS and RJ substantially contributed to the general idea and design of the study. PS, RJ, NK, TP planned the data collection and analysis. PS drafted the manuscript. RJ,\u0026nbsp;NK and TP revised the manuscript.\u0026nbsp;All authors have read and consented to the manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNone\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eAntunes LdC, Levandovski R, Dantas G, Caumo W, Hidalgo M. Obesity and shift work: chronobiological aspects. Nutr Res Rev. 2010;23(1):155\u0026ndash;68.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eZhang Q, Ying CS, Shan LSH, Pak-Chun CJ, Schwade M, Zhao X. Association between shift work and obesity among nurses: A systematic review and meta-analysis. Int J Nurs Stud. 2020:103757.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSun M, Feng W, Wang F, Li P, Li Z, Li M, et al. Meta-analysis on shift work and risks of specific obesity types. 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J Diabetes Res. 2019;2019:2046428.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePeplonska B, Bukowska A, Sobala W. Association of Rotating Night Shift Work with BMI and Abdominal Obesity among Nurses and Midwives. PLoS ONE. 2015;10(7):e0133761-e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eTaheri S, Lin L, Austin D, Young T, Mignot E. Short sleep duration is associated with reduced leptin, elevated ghrelin, and increased body mass index. PLoS Med. 2004;1(3):e62.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHulsegge G, Boer JM, van der Beek AJ, Verschuren WM, Sluijs I, Vermeulen R, et al. Shift workers have a similar diet quality but higher energy intake than day workers. Scand J Work Environ Health. 2016:459\u0026ndash;68.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAsher G, Sassone-Corsi P. Time for food: the intimate interplay between nutrition, metabolism, and the circadian clock. Cell. 2015;161(1):84\u0026ndash;92.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHaus E, Reinberg A, Mauvieux B, Le Floc\u0026rsquo;h N, Sackett-Lundeen L, Touitou Y. Risk of obesity in male shift workers: a chronophysiological approach. Chronobio Int. 2016;33(8):1018\u0026ndash;36.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCain SW, Filtness AJ, Phillips CL, Anderson C. Enhanced preference for high-fat foods following a simulated night shift. Scand J Work Environ Health. 2015:288\u0026ndash;93.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGoldstein DJ. Beneficial health effects of modest weight loss. Int J Obes Relat Metab Disord. 1992;16(6):397\u0026ndash;415.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSartorio A, Ottolini S, Agosti F, Massarini M, Lafortuna C. Three-week integrated body weight reduction programme markedly improves performance and work capacity in severely obese patients. Eat Weight Disord. 2003;8(2):107\u0026ndash;13.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLasikiewicz N, Myrissa K, Hoyland A, Lawton CL. Psychological benefits of weight loss following behavioural and/or dietary weight loss interventions. A systematic research review. Appetite. 2014;72:123\u0026ndash;37.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHeymsfield S, Van Mierlo C, Van der Knaap H, Heo M, Frier H. Weight management using a meal replacement strategy: meta and pooling analysis from six studies. Int J Obes. 2003;27(5):537\u0026ndash;49.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCheskin LJ, Mitchell AM, Jhaveri AD, Mitola AH, Davis LM, Lewis RA, et al. Efficacy of meal replacements versus a standard food-based diet for weight loss in type 2 diabetes a controlled clinical trial. Diabetes Educ. 2008;34(1):118\u0026ndash;27.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eDavis LM, Coleman C, Kiel J, Rampolla J, Hutchisen T, Ford L, et al. Efficacy of a meal replacement diet plan compared to a food-based diet plan after a period of weight loss and weight maintenance: a randomized controlled trial. Nutr J. 2010;9:11-.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eChan A-W, Tetzlaff JM, Altman DG, Laupacis A, G\u0026oslash;tzsche PC, Krleža-Jerić K, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200\u0026ndash;7.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eChristensen R, Astrup A, Bliddal H. Weight loss: the treatment of choice for knee osteoarthritis? A randomized trial. Osteoarthritis Cartilage. 2005;13(1):20\u0026ndash;7.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSomasundaram N, Rajaratnam D, Wijeyarathne P, Katulanda P, de Silva KSH, Wickramasinghe P, et al. Management of obesity. Sri Lanka Journal of Diabetes Endocrinology and Metabolism (SJDEM). 2014;1:55\u0026ndash;70.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eRush E, Chandu V, Plank L. Prediction of fat-free mass by bioimpedance analysis in migrant Asian Indian men and women: a cross validation study. Int J Obes. 2006;30(7):1125\u0026ndash;31.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eJayawardena R, Swaminathan S, Byrne NM, Soares MJ, Katulanda P, Hills AP. Development of a food frequency questionnaire for Sri Lankan adults. Nutr J. 2012;11(1):1\u0026ndash;6.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCraig CL, Marshall AL, Sj\u0026ouml;str\u0026ouml;m M, Bauman AE, Booth ML, Ainsworth BE, et al. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003;35(8):1381\u0026ndash;95.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eJoseph B, Joseph M. The health of the healthcare workers. Indian J Occup Environ Med. 2016;20(2):71\u0026ndash;2.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAbubakar MB, Uthman YA, Ibrahim KG. Prevalence of overweight and obesity among health-care workers in Ghana: A systematic review. Nigerian J Exp Clin Biosci. 2021;9(1):47.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGarrido RA, Semeraro MB, Temesgen SM, Simi MR. Metabolic syndrome and obesity among workers at Kanye Seventh-day Adventist Hospital, Botswana. S Afr Med J. 2009;99(5).\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGeliebter A, Gluck ME, Tanowitz M, Aronoff NJ, Zammit GK. Work-shift period and weight change. Nutrition. 2000;16(1):27\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eS\u0026oslash;vold LE, Naslund JA, Kousoulis AA, Saxena S, Qoronfleh MW, Grobler C, et al. Prioritizing the Mental Health and Well-Being of Healthcare Workers: An Urgent Global Public Health Priority. Front Public Health. 2021;9.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSouza RV, Sarmento RA, de Almeida JC, Canuto R. The effect of shift work on eating habits: a systematic review. Scand J Work Environ Health. 2018;45(1):7\u0026ndash;21.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eDe Assis MAA, Nahas M, Bellisle F, Kupek E. Meals, snacks and food choices in Brazilian shift workers with high energy expenditure. J Hum Nutr Diet. 2003;16(4):283\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLopez-Minguez J, G\u0026oacute;mez-Abell\u0026aacute;n P, Garaulet M. Timing of Breakfast, Lunch, and Dinner. Effects on Obesity and Metabolic Risk. Nutrients. 2019;11(11):2624.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLowden A, Moreno C, Holmb\u0026auml;ck U, Lennern\u0026auml;s M, Tucker P. Eating and shift work\u0026mdash;effects on habits, metabolism, and performance. Scand J Work Environ Health. 2010:150\u0026ndash;62.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePhoi YY, Keogh JB. Dietary interventions for night shift workers: a literature review. Nutrients. 2019;11(10):2276.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eNoakes M, Foster PR, Keogh JB, Clifton PM. Meal replacements are as effective as structured weight-loss diets for treating obesity in adults with features of metabolic syndrome. J Nutr. 2004;134(8):1894\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"trials","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"trls","sideBox":"Learn more about [Trials](http://trialsjournal.biomedcentral.com/)","snPcode":"13063","submissionUrl":"https://www.editorialmanager.com/trls","title":"Trials","twitterHandle":"MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Shift work, obesity, weight loss, meal replacement, low-calorie ","lastPublishedDoi":"10.21203/rs.3.rs-1415732/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-1415732/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground:\u003c/strong\u003e Shift work\u0026nbsp;is considered a risk factor\u0026nbsp;for a number of chronic health conditions including obesity. Weight reduction in obese patients lowers\u0026nbsp;the\u0026nbsp;risk\u0026nbsp;for cardiovascular disease, diabetes, certain cancers, and mortality. Achieving a negative energy balance by providing low-calorie meal replacements is widely used for weight management. This study aims to evaluate the impact of a low calorie “meal-replacement” on weight and metabolic parameters of shift workers with obesity.\u0026nbsp;\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eMethods:\u003c/strong\u003e\u0026nbsp;This trial will be conducted in parallel, randomized controlled design for a period of 8 weeks. A total of 44 shift workers with Body Mass Index over 25 kg/m\u003csup\u003e2 \u003c/sup\u003ewill be recruited after assessing eligibility. Participants will be randomly assigned to the test and control groups on a 1:1 ratio. The intervention group (N=22) will be provided with a low calorie (~200 kcal) meal replacement shake as a dinner, and the control group (N=22) will continue their habitual diets. The visits and the evaluations will be done as follows: screening (visit 0), 4 weeks (visit 1), and 8 weeks (visit 2). Anthropometric measurements will be taken at 0, 4 and 8 weeks. Body composition, biochemical parameters, dietary intake and physical activity will be assessed during the first and the last visit. \u0026nbsp;\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eOutcomes:\u003c/strong\u003e The primary outcome will be body weight loss, and the proportion of participants that had a 5% body weight loss from baseline. The secondary outcomes will be post intervention changes in the other metabolic parameters.\u0026nbsp;\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eDiscussion:\u003c/strong\u003e To our knowledge this is one of the first randomized controlled trials evaluating the effects of a meal replacement as the night meal for weight loss in shift worker with obesity. Moreover, improvement of metabolic parameters in shift-workers will be an added benefit to this high risk group. \u0026nbsp;\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eTrial registration: \u003c/strong\u003eAustralian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12622000231741. Registered on 09 February 2022. https://www.anzctr.org.au/ACTRN12622000231741.aspx\u003c/p\u003e","manuscriptTitle":"Meal replacement as a weight loss strategy for night shift workers with obesity: a protocol for a randomized controlled trial","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2022-04-08 14:13:23","doi":"10.21203/rs.3.rs-1415732/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Major revision","date":"2022-09-16T20:22:50+00:00","index":"","fulltext":""},{"type":"reviewerAgreed","content":"","date":"2022-07-26T18:12:19+00:00","index":0,"fulltext":""},{"type":"editorInvitedReview","content":"","date":"2022-04-06T07:34:03+00:00","index":0,"fulltext":""},{"type":"reviewersInvited","content":"","date":"2022-04-06T05:07:14+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2022-04-06T05:02:54+00:00","index":"","fulltext":""},{"type":"submitted","content":"Trials","date":"2022-03-03T08:41:33+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"trials","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"trls","sideBox":"Learn more about [Trials](http://trialsjournal.biomedcentral.com/)","snPcode":"13063","submissionUrl":"https://www.editorialmanager.com/trls","title":"Trials","twitterHandle":"MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"ebe59f59-fced-4406-802e-c8f875fcc862","owner":[],"postedDate":"April 8th, 2022","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[],"tags":[],"updatedAt":"2022-09-20T14:45:08+00:00","versionOfRecord":[],"versionCreatedAt":"2022-04-08 14:13:23","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-1415732","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-1415732","identity":"rs-1415732","version":["v1"]},"buildId":"7rjqhiLT3MXkJMwkYKINL","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}