Recruitment of individuals into a type 2 diabetes prevention program: key barriers and enablers identified from the randomised control trial testing an Australian Lifestyle Change Program (AUS2PREVENT)

Recruitment of individuals into a type 2 diabetes prevention program: key barriers and enablers identified from the randomised control trial testing an Australian Lifestyle Change Program (AUS2PREVENT) | 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 Recruitment of individuals into a type 2 diabetes prevention program: key barriers and enablers identified from the randomised control trial testing an Australian Lifestyle Change Program (AUS2PREVENT) Amy Kaim, Fiona Benton, Hossein Haji Ali Afzali, Shahid Ullah, and 3 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-6482322/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 17 Jan, 2026 Read the published version in Pilot and Feasibility Studies → Version 1 posted 3 You are reading this latest preprint version Abstract Background Governments worldwide consider randomised controlled trials (RCTs) as the accepted gold standard design to evaluate healthcare interventions. However, enrolling participants into RCTs can be challenging, with recruitment processes serving as a crucial determinant of any clinical trial or program’s success. This study aimed to characterise the relative effectiveness and cost of different strategies used to recruit individuals into a randomised control trial of an Australian Lifestyle Change Program (AUS2PREVENT) to prevent or delay type 2 diabetes in South Australia. Methods Targeted recruitment over a 12-month period through General Practitioner (GP) clinics was the primary strategy used to recruit individuals at risk of, or with prediabetes. After protocol amendments, around 25,000 individuals were identified as having prediabetes and being potentially eligible for the trial from 279 GP clinics across metropolitan Adelaide. Additional channels used to recruit self-referring, high risk individuals, included radio, online media (e.g., Facebook, Instagram, webpages), email distribution lists, and member-orientated magazines/ newsletters associated with the supporting health and community organisations. Results Of the 1,393 expressions of interest, 587 individuals completed the pre-screening survey and reported the referral channel. Radio, email and online media generated the greatest number of individuals expressing interest in the trial (284 vs 151 vs 91, respectively) and accounted for the final 67 individuals who were enrolled and randomised. Promotion through GP clinics, radio, and online media were the costliest strategies; only 4 individuals reported being referred by their GP. Conclusions Timely and cost-effective recruitment of people into a preventive health program requires a recruitment strategy that is adaptive, multi-channelled, location-specific and appropriate for the population being targeted and the trial design being used. To optimise engagement in such programs, further research is warranted to explore the experiences and perspectives of individuals participating in preventive health interventions. Additionally, gaining deeper insights into the views of GPs, clinic managers, and other staff within the Primary Health Network is vital to understanding their role in referring high-risk individuals to trials evaluating prevention programs. Trial Registration: The trial is registered on the Australian New Zealand Clinical Trials Registry (ANZCTR), Universal Trial Number U1111-1220-5636. Type 2 diabetes prevention Lifestyle modification Randomised control trial Recruitment strategies Targeted promotion General Practice referral Barriers and enablers. Figures Figure 1 Figure 2 Key messages regarding feasibility What uncertainties existed regarding the feasibility? The feasibility of recruiting enough participants in a 1-year timeline. The feasibility of recruiting people at risk of type 2 diabetes predominantly through general practice clinics that were engaged to support the trial. The feasibility of individuals completing all stages of the recruitment & screening process. What are the key feasibility findings? Promoting prevention interventions/programs through GP clinics is challenging. The effort and cost of recruiting individuals through GP clinics were disproportionately higher than recruitment of individuals through radio, email and online media strategies. What are the implications of the feasibility findings for the design of the main study? The findings of this study provide important information about the feasibility of engaging and recruiting high risk people into preventive health interventions. Background Diabetes is a major public health issue, causing premature death and imposing a significant disease burden globally. The Global Burden of Disease study forecasts a 3.3% annual increase in diabetes prevalence worldwide, with type 2 diabetes accounting for more than 90% of all cases (1). In the United States, the total annual cost of type 2 diabetes (including direct and indirect costs, loss of productivity and premature mortality) in 2022 was estimated to be $412.9 billion (2). Within Australia, projections estimate that more than 3.1 million individuals will have type 2 diabetes by 2050, and the total annual cost of this condition will be approximately $45 billion (3). Over the last two decades, international (4-6) and national (7) clinical research has established that sustained changes in lifestyle factors, including nutrition and exercise, can prevent up to 58% of type 2 diabetes cases or delay their onset by up to 14 years, particularly for individuals with prediabetes whose body weight is reduced by ≥5%. However, scaling up effective prevention health programs for reducing type 2 diabetes and/or obesity remains challenging, thereby limiting the programs reach and impact (8-11). Data from the United States show that despite massive collaborative effort of around 1,500 organisations, only about 0.4% of Americans at high risk of developing type 2 diabetes have joined a diabetes prevention program (8). Governments worldwide, including Australia, consider randomised controlled trials (RCTs) the accepted gold standard design for evaluating healthcare interventions, with the findings ultimately guiding clinical practice (12, 13). Irrespective of the chronic condition being targeted, data from the Australian New Zealand Clinical Trials Registry (ANZCTR) indicate that only 42% of all clinical trials are ever completed (14).The median sample size of public health trials conducted in 2020 was approximately 120 participants (interquartile range 58 to 755 participants), whereas the median sample size of all registered clinical trials was approximately 80 (interquartile range 33 to 200 participants) (14). These results underscore that even RCTs dedicated to developing efficient participant recruitment strategies face considerable challenges in quickly enrolling a few hundred participants to inform the scalability of a program (15, 16). Although most of the information about the logistics, effectiveness and cost of various strategies used to recruit individuals into RCTs evaluating the feasibility and effectiveness of obesity and diabetes prevention programs comes from the U.S. (8, 9), some information comes from other countries, including Australia (17-19). For example, Bessell and colleagues (17) provided substantial detail on the logistics and costs of various strategies used to recruit Australian adults with prediabetes into a type 2 diabetes prevention RCT. Radio advertising followed by promoting the trial through healthcare networks were the most effective and cost-effective (i.e., low-effort high-yield) recruitment strategies, with each contributing 46% and 19%, respectively, to the final number of participants who were ultimately randomised. However, other RCTs that have recruited patients through healthcare networks, including General Practitioner (GP) clinics, have reported rates of success varying between ~10% and ~30% (7, 17, 19-21). Several factors that have been associated with higher referral rates from GP clinics include ensuring that the clinics have good awareness of the RCTs they are being asked to support, ensuring that they are aware of government-funded financial incentives aimed at supporting high-quality healthcare (e.g., for Australia, the Australian Government Quality Improvement Practice Incentive Program and the Practice Nurse Incentive Program) and that clinics use a streamlined patient management record system to assist in identifying eligible individuals (8, 20, 22, 23). This study aimed to build on the limited information that is currently available by characterising the relative effectiveness and cost of different strategies used to recruit high-risk individuals into a randomised control trial of an Australian Lifestyle Change Program (AUS2PREVENT) to prevent or delay type 2 diabetes in South Australia. We hypothesised that recruitment from GP clinics would be the most successful recruitment strategy. Methods Trial design A two-arm, parallel, stratified block-randomised controlled, community-based trial was used to evaluate the feasibility, acceptability, and the clinical and cost effectiveness of the ‘AUS2PREVENT program’ compared with ‘Usual Care’ to prevent or delay type 2 diabetes in South Australian’s, aged 18+ years, at high-risk of type 2 diabetes (i.e., scores of 12 or greater on the AUSDRISK (24)), and have at least one additional cardiometabolic risk marker (e.g., overweight/obese, high blood pressure, high lipids). Individuals who were already: diagnosed with type 1 or 2 diabetes or any other serious medical condition; pregnant or planning to become pregnant within the next 12 months; currently involved in a regular and vigorous exercise regime (e.g., training for competitive sport); receiving treatment to lower blood glucose levels; and who were unable or unwilling to give consent, were excluded from the trial. The trial comprised a recruitment phase via a two-staged screening process, followed by a 12-month intervention phase and a 12-month follow-up phase; Additional File 1 depicts the trial design, including the full inclusion and exclusion criteria. The trial protocol was approved by the Southern Adelaide Clinical Human Research Ethics Committee (SAC HREC); the ethics approval number is 344.18-HREC/18/SAC/416, and the trial is available at the Australian New Zealand Clinical Trials Registry (ANZCTR), Universal Trial Number U1111-1220-5636. Recruitment strategies Individuals living, working or attending a GP clinic in four Local Government Areas (LGAs) in metropolitan Adelaide were targeted through various strategies to find up to 600 eligible participants for the trial. It was planned that recruitment would take up to 12 months. The demographic profile of the populations within the selected cities was largely representative of the broader South Australian profile ( see Additional File 2 ). Recruitment commenced November 16, 2021, and was concluded on December 22, 2022; the phasing of each recruitment strategy is depicted in Figure 1 . The primary recruitment strategy was through GP clinics identified by the Adelaide Primary Health Network (PHN) and Diabetes SA stakeholder databases. Prior to engaging with any of the GP clinics, the Adelaide PHN incorporated electronic trial referral forms into patient management systems (i.e., Medical Director, Best Practice and Zedmed), which GPs were able to download, complete and forward to Diabetes SA. To inform the GP clinic staff about the trial, all identified clinics were contacted via email, fax, telephone or face-to-face visits by a member of the research team or a PHN practice facilitator. Recruitment posters and flyers were distributed to clinics that received a face-to-face visit to promote the trial in their waiting and consult rooms. All the recruitment material directed interested health professionals to the Trial Co-ordinator and/or the AUS2PREVENT Trial website (25). The website contained a recorded presentation about the trial, how GPs could refer potential participants, and links to the relevant participant information sheet and consent form (PICF). GPs were not reimbursed by the research team for referring patients to the trial; however, they were eligible for reimbursement related to performing type 2 diabetes screening clinical tests through the Australian Government’s Quality Improvement Practice Incentive Program (26). To facilitate self-referrals, additional channels were used across the 12-month recruitment period, including radio, online media (e.g., Facebook, Instagram, and webpages), newsletters/noticeboards, newspaper articles, and emails or member-orientated magazines to individuals through health and community organisations within Diabetes SA’s collaborative networks. Screening processes St age 1 pre-screening : Individuals interested in or referred to the trial were directed to an online pre-screening survey (via the Qualtrics platform), which took ~15 minutes to complete. Individuals who completed the survey were emailed a copy of the PICF by the Trial team. Individuals were then called to ensure that they understood the expectations of being a trial participant and to give them the opportunity to ask questions. Individuals were instructed to complete and return (via email) all the forms. Stage 2 screening : Consenting individuals who met the Stage 1 screening criteria were sent a referral letter to see their GP for clinical investigations to confirm their eligibility. A copy of the signed consent was forwarded to the individual’s GP (or clinic) and was accompanied by a letter outlining their patient’s expression of interest in the trial. The letter also outlined the specific observations the trial team required to determine eligibility. Once results from a GP were received, the individual’s full eligibility was confirmed. Data collection and analysis Staff involved in all aspects of recruitment were asked to calculate the time they spent (note that some calculations are based on best estimates of time spent) doing each of the following activities: development of recruitment collateral, organising promotional strategies, and moving each individual through the screening process. For each individual who expressed interest in the trial and commenced the screening process, interactions via email and phone (including attempts at contacting them via phone) were recorded in a purpose-built database. The reasons individuals provided for withdrawing from the trial were also recorded. Individuals who did not officially withdraw but who did not complete all screening stages were recorded as lost to follow-up. The pre-screening survey included a question asking individuals to report where they had heard about the trial. For each recruitment strategy, the number of expressions of interest, the number of people booked for an onsite screening, and the number of randomised participants were collated. The direct cost of implementing each recruitment strategy was recorded. The time spent by staff per recruitment channel was not calculated, but the time spent by staff to perform all aspects of the recruitment and screening process was calculated based on their records of time spent per recruitment activity. Importantly, any costs associated with the Adelaide PHN staff who supported our recruitment from GP clinics were not included in our results. Results Protocol amendments as a result of process evaluation during the screening process As a result of slower than desired recruitment, two protocol amendments were sought and approved by the SAC HREC during the recruitment period. In brief, the first amendment (May 24, 2022) related to the expansion of the participant catchment area from the original four LGAs to a total of 11 LGAs. The first amendment was sought because 82 individuals who met most of the inclusion criteria during Stage 1 of the screening process lived or worked in suburbs surrounding the original four LGAs. This amendment increased the total pool of potentially eligible individuals from 1,625 (i.e., those identified from the 76 GP clinics in the original four LGAs) to approximately 25,000. The second amendment (October 25, 2022) related to lowering the prediabetes inclusion criteria because many individuals had HbA1c and/or fasting blood glucose values slightly lower than the current lower cut-off values recommended by the Australian Clinical Guidelines for the diagnosis of prediabetes (i.e., ≥6.0 to ≤6.4% for HbA1c and ≥6.1 to ≤6.9 mmol/L for FBG) (27). Hence, the decision was made to amend the prediabetes criteria to those recommended by the American Diabetes Association (ADA) guidelines (i.e., ≥5.7% to ≤6.4% for HbA1c and ≥5.6 to ≤6.9 mmol/L for FBG) (23). These cut-off values are also in line with the prediabetes cut-off values recommended by the International Expert Committee (IEC) and Australian diabetes experts (24-26). This enabled 22 individuals who were ineligible at the end of screening Stage 2 to be considered for randomisation. Number and characteristics of individuals recruited and screened The flow of individuals through the two staged screening process is depicted in Figure 2 . Reasons for survey non-completion (N=796) were not reported. Individuals who completed Stage 1 screening were predominantly female (68%), on average (±SD) aged 48±12 years, had a body mass index of 33.1±7.2 kg/m 2 , an AUSDRISK score of 16.6±5.3, and 1.2±2.1 chronic medical conditions. Reported reasons for withdrawing at Stage 1 included time restraints related to work or personal commitments (n=18), changes in mind (n=37), recent blood results, other health conditions, or starting a new medication that excluded them from the trial (n=8). The reasons for withdrawing at Stage 2 included no longer having time (n=5), no longer being interested in the trial (n=1), unexpected surgery (n=1), and starting treatment with another health professional (n=2). The 85 individuals who were eligible after completing Stage 2 screening were predominantly female (68%), were aged 54±12 years, had a body mass index of 33.2±6.5 kg/m 2 , an AUSDRISK score of 19.8±4.5, 1.5±2.1 chronic medical conditions, an HbA1c of 5.8±0.3%, a fasting blood glucose of 5.8±0.4 mmol/L, a fasting total cholesterol of 5.1±1.0 mmol/L, a fasting triglyceride of 1.7±1.4 mmol/L, a fasting low-density lipoprotein of 3.0±0.9 mmol/L, and a fasting high-density lipoprotein of 1.3±0.3 mmol/L. However, 7 of the eligible individuals withdrew interest because of a change in personal commitments, which they felt would prevent them from abiding by the trial protocol (n=5), or because of a delay in commencing the intervention phase (n=2). A total of 67 individuals were enrolled in the intervention phase of the trial and randomised into usual care (n=35) or lifestyle change (n=32); this represents approximately 11% of the 587 who completed Stage 1 screening, 39% of the 171 who completed Stage 2 screening, and 4% of everyone who expressed interest in the trial. Relative effectiveness of the various recruitment channels Table 1 summarisesthe relative effectiveness of the various channels used to recruit participants. A more detailed version of this table can be found in Additional File 3 . Among the 587 individuals who reported which recruitment channel they had come through, the greatest percentage came from the radio, followed by email and then online media (i.e., 48% vs 26% vs 16%, respectively). The same three channels also yielded the greatest number of individuals who were eventually enrolled and randomised (i.e., 21% vs 23% vs 11%, respectively). Only 4 individuals reported being referred by their GP or learning from flyers/messages in GP clinics. Staff time spent on the various recruitment channels Table 1 includes the direct cost of promoting the trial via the different recruitment strategies; personnel and indirect business costs are excluded. The total direct cost of promoting the trial was $40,874. In terms of cost per promotion channel (excluding staff time), many channels had low or no costs, as they were digital – i.e., emails, digital articles, and word of mouth. In contrast, the cost of promotion was greatest for radio, followed by online media, GPs/GP clinics, and then flyers distributed to public councils and placed on other public noticeboards. Regarding direct costs associated with staff, approximately 1 full-time equivalent (FTE) over a period of approximately 2.5 years was required to develop recruitment collateral, organise promotional strategies, and move individuals through the two-staged screening process; this was determined from a mixture of recorded and estimated time per activity. Of this 1 FTE, approximately 0.15 FTE related to the creation of promotional material and conversations with GPs and/or Practice Nurses, 0.01 FTE related to the development of promotional collateral for radio and targeted emails, and the remaining 0.8 FTE related to moving individuals through the two screening stages to determine their eligibility. [Table 1 should be inserted here] Discussion After 12 months of recruiting, 67 high-risk South Australians were screened as eligible for enrolment in this community-based randomised control trial testing an evidence-based type 2 diabetes prevention program. This figure represents 4% of all individuals who expressed interest in the trial, 11% of the 587 who completed Stage 1 screening, and 39% of the 171 who completed Stage 2 screening. Radio, followed by email and online media, were the key recruitment strategies that generated the greatest interest in the trial and accounted for the 67 individuals who were ultimately enrolled and randomised into one of the two trial treatments. Despite the trial team engaging with the local Adelaide PHN and 279 GP clinics across metropolitan South Australia, only four participants came from GP or health professional referrals. With respect to the costs associated with recruitment, direct costs related to staff were the most expensive aspect of recruitment, but these costs were similar across the different strategies. Excluding staff costs, the greatest expenditure was related to promotional collateral used for radio, followed by online media and GP clinics. The current trial recruited only 11% of the targeted 600 individuals over 12 months. Importantly, we did not extend the recruitment period to minimise the risk of 85 eligible participants withdrawing before starting the intervention. Closing the recruitment on time proved to be a wise decision, as we observed further attrition of 18 individuals who could not be contacted or withdrew due to other commitments (i.e., work or travel). Despite not achieving our original target, our sample size was comparable with the median sample size reported in the 2020 ANZCTR for all public health trials, which is 80 participants (14). More importantly, our findings show that direct spending of approximately $40,874 to promote a type 2 prevention trial via eight different recruitment channels, coupled with the direct and indirect business costs of employing 1 full-time equivalent (FTE) over a period of approximately 2.5 years, ultimately identified 67 eligible South Australians. While we considered calculating and comparing the costs of recruitment at the per participant randomised level (as has been previously reported by others (17, 19)) doing so can lead to misleading conclusions because RCTs have used different designs, and the costs (especially staff direct and indirect costs) related to recruitment tend to differ considerably between organisations. What is critically important is that organisations planning to implement scalable prevention programs understand the program features and logistics that are cost-effective. Consistent with our findings, previous preventive health trials reported that the absolute number of people referred from GPs was lower than those referred from other strategies (18, 19, 28). While we hoped that notifying GP clinics about the Australian Government Quality Improvement Practice Incentive Program would help support GP clinics to refer individuals into our trial, financial incentives appear to be underutilised across Australia for a variety of reasons, including a lack of awareness of all available practice incentives and issues related to organisational readiness to support the delivery of interventions (29). Insights from the implementation research of community preventive health programs suggest that GP/health professional referrals are highest when there is widespread public awareness about a program and its benefits, and the program is well integrated into multiple systems within the primary healthcare setting; achieving this usually takes several years (28, 30-34). Data from the US (33, 35-37), the UK (32, 34) and Australia (10, 38, 39) also indicate that the views and attitudes of GPs or GP clinic staff contribute to the level at which individuals are referred to trials evaluating preventive health interventions. Some health professionals may lack knowledge about health conditions, others may not perceive the evidence base behind the intervention as credible, and some may not believe that the intervention is tailored enough to their patients’ needs (38). Some GPs may be reluctant to refer their patients to a public health trial because of ethical concerns with the randomisation process, even if both the new treatment and usual care can benefit a participant (32, 40-42). Others consider promoting preventive health trials or referring individuals into them as not their primary role (40) and others may find it challenging to have conversations for a variety of reasons (38). In addition, structural barriers that shape GP workloads can also prevent GPs from referring individuals to preventive health interventions (32). These barriers may include a lack of time due to already heavy workloads (43); a lack of clear processes in how to coordinate the referral of high-risk individuals to such programs; a lack of demand or buy in from potentially eligible patients they have on their clinic database (39); fluctuating volumes of individuals coming to see the GP and, when they do see their GP, attending for a specific reason; a lack of high-quality promotional material that can be placed within clinic waiting rooms or used for direct messaging to inform individuals of the importance of detection and early intervention of type 2 diabetes; and financial incentives that do not recoup the true cost (including oncosts) of supporting referrals (39). A major limitation of the current trial was that, regardless of the recruitment strategy, many individuals did not complete Stage 1 of screening (i.e., the online pre-screening survey). Unfortunately, neither we nor others (16-18) have been able to confirm why high numbers of individuals self-determine that they are not eligible for clinical trials. For future implementation of preventive health interventions, understanding the reasons that individuals express interest but then drop out of a program is critical, as it will assist with tailoring messages to effectively engage a high number of the target audience that will benefit the most. Conclusions These findings demonstrate that timely and cost-effective recruitment of people into a trial testing a preventive health program requires a recruitment strategy that is adaptive, multi-channelled, location-specific and appropriate for the population being targeted and the trial design being used. A high level of co-ordination between key health organisations, time to build awareness and trust, and a significant trial marketing and communication budget are essential to engage high-risk individuals in prevention programs to reduce type 2 diabetes or other related chronic conditions. Further research is needed to understand the experiences and perspectives of individuals who engage in preventive health interventions compared with those who do not. In addition, understanding the perspectives of GPs, GP clinic managers and other staff within the Primary Health Network regarding the barriers they experience in referring high-risk individuals to gold-standard randomised control trials is needed, as these trials are important for determining the most clinical and cost-effective preventive health interventions. Abbreviations ANZCTR; Australian New Zealand Clinical Trial Register AUSDRISK: Australian type 2 diabetes risk assessment tool FBG: fasting blood glucose FTE: Full-Time Equivalent GP: General Practitioner HbA1c: Haemoglobin A1c LGA: Local Government Area NDSS: National Diabetes Services Scheme PHN: Primary Health Network PICF: Participant Information Sheet and Consent Form RCT: Randomised control trial RACGP: The Royal Australian College of General Practitioners SAC HREC: Southern Adelaide Clinical Human Research Ethics Committee Declarations Ethics approval and consent to participate: The study protocol was approved by the Southern Adelaide Clinical Human Research Ethics Committee (SAC HREC), ethics approval number 344.18-HREC/18/SAC/416. The PICF was available online for potential participants to read prior to completing the screening questionnaire. Eligible individuals (see Additional File 1 for criteria) were emailed a copy of the PICF by the Trial team. Individuals were then called to ensure that they understood the expectations of being a trial participant and to give them the opportunity to ask questions. Individuals were instructed to complete and return (via email) all the forms. Consent for publication Not applicable Availability of data and materials Data sharing is not applicable to this article, as no datasets were generated or analysed during the current study. Competing interests The authors declare that they have no conflicts of interest. Funding Authors HA, CP, SU and PW received support from Diabetes SA for evaluating the trial outcomes. Authors' contributions All the authors were involved in the planning stages of the trial design. AK, NLM and FB led the analysis and wrote the manuscript. HA, CP, SU and PW interpreted the data for the outcomes presented in this paper. All the authors read and approved the final manuscript. Acknowledgements The authors would like to acknowledge Diabetes SA for funding the trial and the support of the Adelaide Primary Health Network, who assisted with the identification of GP clinics within the trial areas. We also thank all the general practice staff who assisted us in our recruitment phase and the individuals who expressed interest in and contributed to this research.We would also like to thank Dr. Amy Hutchison (University of Adelaide, Australia) for screening their existing participant databases andemailing trial information to those who may be eligible. References G. B. D. Diabetes Collaborators. Global, regional, and national burden of diabetes from 1990 to 2021, with projections of prevalence to 2050: a systematic analysis for the Global Burden of Disease Study 2021. Lancet. 2023;402:10397:203-34. Parker ED, Lin J, Mahoney T, Ume N, Yang G, Gabbay RA, et al. Economic Costs of Diabetes in the U.S. in 2022. Diabetes Care. 2023;47:1:26-43. Diabetes Australia. State of the Nation Report 2024. The Diabetes Epidemic in Australia. 2024. Accessed. https://www.diabetesaustralia.com.au/wp-content/uploads/State-of-the-Nation-2024-Diabetes-Australia.pdf. Lindström J, Peltonen M, Eriksson J, Ilanne-Parikka P, Aunola S, Keinänen-Kiukaanniemi S, et al. Improved lifestyle and decreased diabetes risk over 13 years: long-term follow-up of the randomised Finnish Diabetes Prevention Study (DPS). Diabetologia. 2013;56:2:284-93. Knowler WC, Fowler SE, Hamman RF, Christophi CA, Hoffman HJ, Diabetes Prevention Program Research G. 10-year follow-up of diabetes incidence and weight loss in the Diabetes Prevention Program Outcomes Study. 2009;374:1677-86. Hemmingsen B, Gimenez-Perez G, Mauricio D, Roque IFM, Metzendorf MI, Richter B. Diet, physical activity or both for prevention or delay of type 2 diabetes mellitus and its associated complications in people at increased risk of developing type 2 diabetes mellitus. The Cochrane database of systematic reviews. 2017;12:Cd003054. Laatikainen T, Dunbar JA, Chapman A, Kilkkinen A, Vartiainen E, Heistaro S, et al. Prevention of type 2 diabetes by lifestyle intervention in an Australian primary health care setting: Greater Green Triangle (GGT) Diabetes Prevention Project. BMC Public Health. 2007;7:249. Ackermann RT, O’Brien MJ. Evidence and Challenges for Translation and Population Impact of the Diabetes Prevention Program. Current Diabetes Reports. 2020;20:3. Ely EK, Gruss SM, Luman ET, Gregg EW, Ali MK, Nhim K, et al. A National Effort to Prevent Type 2 Diabetes: Participant-Level Evaluation of CDC’s National Diabetes Prevention Program. Diabetes Care. 2017;40:10:1331-41. Dunbar JA. Diabetes Prevention in Australia: 10 Years Results and Experience. Diabetes Metab J. 2017;41:3:160-7. Delahanty LM, Nathan DM. Implications of the diabetes prevention program and Look AHEAD clinical trials for lifestyle interventions. J Am Diet Assoc. 2008;108:4 Suppl 1:S66-72. Alsan M, Finkelstein AN. Beyond Causality: Additional Benefits of Randomized Controlled Trials for Improving Health Care Delivery. Milbank Q. 2021;99:4:864-81. National Health and Medical Research Council. A guide to the development, implementation and evaluation of clinical practice guidelines. 1999. Accessed 07 February 2025. https://www.nhmrc.gov.au/sites/default/files/images/a-guide-to-the-development-and-evaluation-of-clinical-practice-guidelines.pdf. Willson ML SA, Aberoumand M, Williams JG, Hunter KE, Barba A, Webster AC, Askie LM, Simes RJ. Latest update of the clinical trials landscape in Australia 2006 – 2020. 2022. Accessed 11 July 2024. https://doi.org/10.25910/t9n1-bm45. McDonald AM, Knight RC, Campbell MK, Entwistle VA, Grant AM, Cook JA, et al. What influences recruitment to randomised controlled trials? A review of trials funded by two UK funding agencies. Trials. 2006;7:9. Robinson JL, Fuerch JH, Winiewicz DD, Salvy SJ, Roemmich JN, Epstein LH. Cost effectiveness of recruitment methods in an obesity prevention trial for young children. Preventive Medicine. 2007;44:6:499-503. Bessell E, Markovic TP, Caterson ID, Hendy C, Burk J, Picone T, et al. Cost-effectiveness analysis of recruitment strategies in a large diabetes prevention trial conducted across two sites in Sydney, Australia. Contemporary Clinical Trials. 2024;137:107421. Hsu MS, Harper C, Gibson AA, Sweeting AN, McBride J, Markovic TP, et al. Recruitment strategies for a randomised controlled trial comparing fast versus slow weight loss in postmenopausal women with obesity—The tempo diet trial. Healthcare. 2018;6:3:76. Miller EG, Nowson CA, Dunstan DW, Kerr DA, Solah V, Menzies D, et al. Recruitment of older adults with type 2 diabetes into a community-based exercise and nutrition randomised controlled trial. Trials. 2016;17:1:467. Parker S, Tran A, Saito S, McNamara C, Denney-Wilson E, Nutbeam D, et al. Exploring organisational readiness to implement a preventive intervention in Australian general practice for overweight and obese patients: key learnings from the HeLP-GP trial. Australian Journal of Primary Health. 2024;30:1. Barnett AG, Glasziou P. Target and actual sample sizes for studies from two trial registries from 1999 to 2020: an observational study. BMJ Open. 2021;11:12:e053377. Afzali HHA, Karnon J, Beilby J, Gray J, Holton C, Banham D. Practice nurse involvement in general practice clinical care: policy and funding issues need resolution. Australian Health Review. 2014;38:3:301-5. Afzali HHA, Karnon J, Gray J, Beilby J. A model-based evaluation of collaborative care in management of patients with type 2 diabetes in Australia: an initial report. Australian Health Review. 2012;36:3:258-63. Department of Health. Australian type 2 diabetes risk assessment tool (AUSDRISK) 2016; Accessed 20 July 2018. http://www.health.gov.au/preventionoftype2diabetes. Diabetes SA. AUS2PREVENT Trial 2021; Accessed 15 November 2021. https://www.diabetessa.com.au/Web/AUS2PREVENT. The Royal Australian College of General Practitioners. Practice Incentives Program Quality Improvement Incentive (PIP QI) fact sheet. 2020. Accessed 23 June 2020. The Royal Australian College of General Practitioners. Management of type 2 diabetes: A handbook for general practice. Defining and diagnosing type 2 diabetes 2024; Accessed 11 October 2024. https://www.racgp.org.au/clinical-resources/clinical-guidelines/key-racgp-guidelines/view-all-racgp-guidelines/diabetes/defining-and-diagnosing-type-2-diabetes. O'Hara BJ, Eggins D, Phongsavan P, Milat AJ, Bauman AE, Wiggers J. Piloting proactive marketing to recruit disadvantaged adults to a community-wide obesity prevention program. Public Health Res Pract. 2015;25:e2521521. KPMG. Effectiveness Review of General Practice Incentives. Sydney, New South Wales. 2024. Accessed 04 April 2025. Griffith University My health for life Evaluation Team. My health for life Program Evaluation Report. Evaluation findings from inception to 31 December 2019. 2020. Accessed 06 November 2024. Victorian government, Diabetes Victoria. Life! Program Evaluation Overview 2022–2023. Victoria, Australia: Department of Health. 2024. Accessed 09 February 2021. Fletcher B, Gheorghe A, Moore D, Wilson S, Damery S. Improving the recruitment activity of clinicians in randomised controlled trials: a systematic review. BMJ Open. 2012;2:1:e000496. Alva ML, Chakkalakal RJ, Moin T, Galaviz KI. The Diabetes Prevention Gap And Opportunities To Increase Participation In Effective Interventions. Health Aff (Millwood). 2022;41:7:971-9. Stokes J, Gellatly J, Bower P, Meacock R, Cotterill S, Sutton M, et al. Implementing a national diabetes prevention programme in England: lessons learned. BMC health services research. 2019;19:1:991-. Halley MC, Petersen J, Nasrallah C, Szwerinski N, Romanelli R, Azar KMJ. Barriers and Facilitators to Real-world Implementation of the Diabetes Prevention Program in Large Healthcare Systems: Lifestyle Coach Perspectives. Journal of General Internal Medicine. 2020;35:6:1684-92. Nhim K, Khan T, Gruss S, Wozniak G, Kirley K, Schumacher P, et al. Facilitators to referrals to CDC's National Diabetes Prevention Program in primary care practices and pharmacies: DocStyles 2016–2017. Preventive Medicine. 2021;149:106614. Tseng E, Greer RC, O'Rourke P, Yeh HC, McGuire MM, Albright AL, et al. National Survey of Primary Care Physicians' Knowledge, Practices, and Perceptions of Prediabetes. J Gen Intern Med. 2019;34:11:2475-81. The Royal Australian College of General Practitioners. Views and attitudes towards physical activity and nutrition counselling in general practice: National survey report 2019. 2019. Terry D, Hills D, Bradley C, Govan L. Nurse‐led clinics in primary health care: A scoping review of contemporary definitions, implementation enablers and barriers and their health impact. Journal of clinical nursing. 2024;33:5:1724-38. Moffat KR, Shi W, Cannon P, Sullivan F. Factors associated with recruitment to randomised controlled trials in general practice: a systematic mixed studies review. Trials. 2023;24:1:90. Hunt CJ, Shepherd LM, Andrews G. Do doctors know best? Comments on a failed trial. Med J Aust. 2001;174:3:144-6. Lockery JE, Collyer TA, Abhayaratna WP, Fitzgerald SM, McNeil JJ, Nelson MR, et al. Recruiting general practice patients for large clinical trials: lessons from the Aspirin in Reducing Events in the Elderly (ASPREE) study. Medical Journal of Australia. 2019;210:4:168-73. Diabetes.co.uk: the global diabetes community. GPs incentivised for referrals following low Diabetes Prevention Programme enrolment 2017; Accessed 01 November 2024. https://www.diabetes.co.uk/news/2017/aug/gps-incentivised-for-referrals-following-low-diabetes-prevention-programme-enrolment-97146663.html. Table Table 1 Cost and reach of the recruitment channels used in the AUS2PREVENT trial. Recruitment Channel & Cost (excludes personnel costs) Per Recruitment Channel Number of times used Reach Individual expressions of interest (N) Screened eligible at Stage 1 (N) Screened eligible at Stage 2 (N) Randomised (N) Radio: $39,033 4 >543,000 individuals 283 84 32 21 ABC Radio - Yielded a total of 4 expressions of interest and 2 individuals who were eligible at Stage 1. Triple M and SAFM - Yielded a total of 49 (i.e. 28+21) expressions of interest and a total of 14 (6+8) individuals who were eligible at Stage 1. Radio Italia - Yielded a total of 0 expressions of interest but some may not have stated this channel. Not stated - Yielded a total of 230 expressions of interest and a total of 68 individuals who were eligible at Stage 1. Email: $0 ~7 Estimated to have reached >10,000 individuals 151 61 25 23 Diabetes SA ‘e-News’ - Yielded a total of 21 expressions of interest and a total of 10 individuals who were eligible at Stage 1. National Diabetes Services Scheme (NDSS) email - Yielded a total of 29 expressions of interest and a total of 10 individuals who were eligible at Stage 1. Existing databases - Yielded a total of 12 expressions of interest and a total of 8 individuals who were eligible at Stage 1. Not stated - Yielded a total of 89 expressions of interest and a total of 33 individuals who were eligible at Stage 1. Online media (e.g., Facebook, Instagram, webpages): $1,029 ~16 Estimated to have reached few hundred individuals 91 23 12 11 Webpage - Yielded a total of 21 expressions of interest and a total of 7 individuals who were eligible at Stage 1. Social media - Yielded a total of 30 expressions of interest and a total of 9 individuals who were eligible at Stage 1. Not stated - Yielded a total of 40 expressions of interest and a total of 7 individuals who were eligible at Stage 1. Unsure: $ unknown Unknown Unknown 14 4 4 3 Referral pathway not stated as individuals could not remember how they heard about the trial or did not want to specify where they heard about it. Family member / colleague/ Friend: $0 Continuous Unknown 15 7 5 3 Indirect referral from someone in the individual’s life who received information about the trial through one of the alternate referral sources. Newspaper: $0 2 Unknown 13 6 3 3 Boomer section of The Advertiser - Yielded a total of 2 expressions of interest and a total of 1 individual who was eligible at Stage 1. Independent Lifestyle section of The Sunday Mail - Yielded a total of 6 expressions of interest and a total of 3 individuals who were eligible at Stage 1. Not stated - Yielded a total of 5 expressions of interest and a total of 2 individuals who were eligible at Stage 1. Diabetes SA: $0 >5 Estimated to have reached over a few hundred individuals 12 3 1 1 World Diabetes Day - Yielded a total of 1 expression of interest and a total of 0 individuals who were eligible at Stage 1. Clinical delivery - Yielded a total of 1 expression of interest and a total of 1 individual who was eligible at Stage 1. MyLife Magazine - Yielded a total of 0 expressions of interest but some may not have stated this channel. Miscellaneous - Yielded a total of 10 expressions of interest and a total of 2 individuals who were eligible at Stage 1. GP Clinics: $647 Continuous Estimated to have reached >25,000 patients with prediabetes from across 279 clinics in the targeted LGAs. 4 2 1 1 A total of GP 279 clinics in the trial areas were contacted by one of the Trial team. Of these, 252 clinics were provided with information on the trial including referral pathways and the criteria for eligible individuals. Newsletter/ noticeboard: $165 >3 times Estimated to have reached over a few hundred individuals 2 1 1 0 Adelaide PHN - Yielded a total of 0 expressions of interest but some may not have stated this channel. GPEx - Yielded a total of 0 expressions of interest but some may not have stated this channel. The Royal Australian College of General Practitioners - Yielded a total of 0 expressions of interest but some may not have stated this channel. Community noticeboard/newsletter - Yielded a total of 2 expressions of interest and a total of 1 individual who was eligible at Stage 1. Supplementary Files Kaimetal.BMCPilotFeasibilityStudAdditionalFile2.docx Kaimetal.BMCPilotFeasibilityStudAdditionalFile1.docx Kaimetal.BMCPilotFeasibilityStudAdditionalFile3.docx Kaimetal.BMCPilotFeasibilityStudAdditionalFile4.doc Cite Share Download PDF Status: Published Journal Publication published 17 Jan, 2026 Read the published version in Pilot and Feasibility Studies → Version 1 posted Reviewers invited by journal 21 May, 2025 Editor assigned by journal 22 Apr, 2025 First submitted to journal 18 Apr, 2025 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-6482322","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":459989639,"identity":"59ff6ae6-1b27-4080-ac66-835664aae3ca","order_by":0,"name":"Amy Kaim","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAABDUlEQVRIie3PMUvDQBTA8RcCqUPUNSXS+wrvCNQlmq9yx0G6tCA4dA04uJS6ifkWAeHmlBu6FFwLt8TFyaFZJEOgHnYTT+rmcP/hhrv7cfcAXK7/mQ+AMAIFwd9IciDsaALAi/pYcv64SbC7kZPl2n9r2i7NyH3t7dopEKx/JpGeJnyBelaq4JI+sZxXG+YPSwm0shAwpA4NqRSM45AphsAC/1SCZyPEkFWPeoJq8BH3bJ+Rh+aLZDaChgjzCkMVjmNgtVdsD69wG6E6v00uUNNShXO6yAWvtq93ZpZIlBYy0uJ5+N5rcvaylk2XXpuPidWulenV0jY+nOD3Ha8wS2S7bxo0vxy6XC6Xy/QJPJ5gk+2W3WIAAAAASUVORK5CYII=","orcid":"","institution":"Diabetes SA","correspondingAuthor":true,"prefix":"","firstName":"Amy","middleName":"","lastName":"Kaim","suffix":""},{"id":459989640,"identity":"da87a504-ec7d-4e00-b783-2ea55903a2c9","order_by":1,"name":"Fiona Benton","email":"","orcid":"","institution":"Diabetes SA","correspondingAuthor":false,"prefix":"","firstName":"Fiona","middleName":"","lastName":"Benton","suffix":""},{"id":459989641,"identity":"ead41879-afab-421d-9c4e-80c22302b737","order_by":2,"name":"Hossein Haji Ali Afzali","email":"","orcid":"","institution":"Flinders University","correspondingAuthor":false,"prefix":"","firstName":"Hossein","middleName":"Haji Ali","lastName":"Afzali","suffix":""},{"id":459989642,"identity":"f1cb2c03-2fce-487e-8d70-6f6161d1bce4","order_by":3,"name":"Shahid Ullah","email":"","orcid":"","institution":"Flinders University","correspondingAuthor":false,"prefix":"","firstName":"Shahid","middleName":"","lastName":"Ullah","suffix":""},{"id":459989643,"identity":"80b3aa92-6a93-4871-ad9f-36e6064f131d","order_by":4,"name":"Clarabelle Pham","email":"","orcid":"","institution":"Flinders University","correspondingAuthor":false,"prefix":"","firstName":"Clarabelle","middleName":"","lastName":"Pham","suffix":""},{"id":459989644,"identity":"ae62443b-db15-49d2-9262-e99defc926b3","order_by":5,"name":"Paul Ward","email":"","orcid":"","institution":"Torrens University Australia","correspondingAuthor":false,"prefix":"","firstName":"Paul","middleName":"","lastName":"Ward","suffix":""},{"id":459989645,"identity":"e2b5dd9b-2c23-4bc3-9500-16b18e250cb9","order_by":6,"name":"Natalie Luscombe-Marsh","email":"","orcid":"https://orcid.org/0000-0001-9690-4722","institution":"Diabetes SA","correspondingAuthor":false,"prefix":"","firstName":"Natalie","middleName":"","lastName":"Luscombe-Marsh","suffix":""}],"badges":[],"createdAt":"2025-04-19 04:28:41","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-6482322/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-6482322/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1186/s40814-025-01759-6","type":"published","date":"2026-01-17T16:30:03+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":83542984,"identity":"556d1231-b6cd-489f-aa67-58726deced9c","added_by":"auto","created_at":"2025-05-28 08:37:45","extension":"jpg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":65835,"visible":true,"origin":"","legend":"\u003cp\u003eKey recruitment milestones for the AUS2PREVENT trial\u003c/p\u003e","description":"","filename":"1.jpg","url":"https://assets-eu.researchsquare.com/files/rs-6482322/v1/df839ef731ce279ffac7497a.jpg"},{"id":83542990,"identity":"985d5445-9470-4ec9-849e-a0e3e902b97c","added_by":"auto","created_at":"2025-05-28 08:37:45","extension":"jpg","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":93585,"visible":true,"origin":"","legend":"\u003cp\u003eThe flow of individuals through the two staged screening process\u003c/p\u003e","description":"","filename":"2.jpg","url":"https://assets-eu.researchsquare.com/files/rs-6482322/v1/f8668a974eaa19c59d7390d9.jpg"},{"id":100616206,"identity":"c867f0fa-db19-47f7-ab37-70d4f11b9a6d","added_by":"auto","created_at":"2026-01-19 17:41:23","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1479638,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-6482322/v1/3cd5211a-add7-4b7d-bee1-51a81d3ce685.pdf"},{"id":83542988,"identity":"cff05ef5-0256-41da-892e-38d92272b9d3","added_by":"auto","created_at":"2025-05-28 08:37:45","extension":"docx","order_by":3,"title":"","display":"","copyAsset":false,"role":"supplement","size":24383,"visible":true,"origin":"","legend":"","description":"","filename":"Kaimetal.BMCPilotFeasibilityStudAdditionalFile2.docx","url":"https://assets-eu.researchsquare.com/files/rs-6482322/v1/fe3bba8df92bbb643abe1f09.docx"},{"id":83542989,"identity":"17c8a911-e2bb-4700-9f7d-bc5f8b86eec8","added_by":"auto","created_at":"2025-05-28 08:37:45","extension":"docx","order_by":3,"title":"","display":"","copyAsset":false,"role":"supplement","size":350009,"visible":true,"origin":"","legend":"","description":"","filename":"Kaimetal.BMCPilotFeasibilityStudAdditionalFile1.docx","url":"https://assets-eu.researchsquare.com/files/rs-6482322/v1/ca42b3b4b72a2c72cef6b7a3.docx"},{"id":83542985,"identity":"2c2334f7-93ca-4998-8f16-ea50e68eeb82","added_by":"auto","created_at":"2025-05-28 08:37:45","extension":"docx","order_by":4,"title":"","display":"","copyAsset":false,"role":"supplement","size":25737,"visible":true,"origin":"","legend":"","description":"","filename":"Kaimetal.BMCPilotFeasibilityStudAdditionalFile3.docx","url":"https://assets-eu.researchsquare.com/files/rs-6482322/v1/aedd4ef59ad77f24e9c7e1aa.docx"},{"id":83542992,"identity":"f6a9e0bd-df16-4bee-8f9c-77b9d5c4ff66","added_by":"auto","created_at":"2025-05-28 08:37:45","extension":"doc","order_by":5,"title":"","display":"","copyAsset":false,"role":"supplement","size":227840,"visible":true,"origin":"","legend":"","description":"","filename":"Kaimetal.BMCPilotFeasibilityStudAdditionalFile4.doc","url":"https://assets-eu.researchsquare.com/files/rs-6482322/v1/e50d3b732592a4f4cfb5014a.doc"}],"financialInterests":"","formattedTitle":"Recruitment of individuals into a type 2 diabetes prevention program: key barriers and enablers identified from the randomised control trial testing an Australian Lifestyle Change Program (AUS2PREVENT)","fulltext":[{"header":"Key messages regarding feasibility","content":"\u003cp\u003e\u003cstrong\u003eWhat uncertainties existed regarding the feasibility?\u003c/strong\u003e\u003c/p\u003e\n\u003cul\u003e\n \u003cli\u003eThe feasibility of recruiting enough participants in a 1-year timeline.\u003c/li\u003e\n \u003cli\u003eThe feasibility of recruiting people at risk of type 2 diabetes predominantly through general practice clinics that were engaged to support the trial.\u003c/li\u003e\n \u003cli\u003eThe feasibility of individuals completing all stages of the recruitment \u0026amp; screening process.\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e\u003cstrong\u003eWhat are the key feasibility findings?\u003c/strong\u003e\u003c/p\u003e\n\u003cul\u003e\n \u003cli\u003ePromoting prevention interventions/programs through GP clinics is challenging.\u003c/li\u003e\n \u003cli\u003eThe effort and cost of recruiting individuals through GP clinics were disproportionately higher than recruitment of individuals through\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003eradio, email and online media strategies.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eWhat are the implications of the feasibility findings for the design of the main study?\u003c/strong\u003e\u003c/p\u003e\n\u003cul\u003e\n \u003cli\u003eThe findings of this study provide important information about the feasibility of engaging and recruiting high risk people into preventive health interventions.\u003c/li\u003e\n\u003c/ul\u003e"},{"header":"Background","content":"\u003cp\u003eDiabetes is a major public health issue, causing premature death and imposing a significant disease burden globally. The Global Burden of Disease study forecasts a 3.3% annual increase in diabetes prevalence worldwide, with type 2 diabetes accounting for more than 90% of all cases (1). In the United States, the total annual cost of type 2 diabetes (including direct and indirect costs, loss of productivity and premature mortality) in 2022 was estimated to be $412.9 billion\u0026nbsp;(2). Within Australia, projections estimate that\u0026nbsp;more than\u0026nbsp;3.1 million individuals will have type 2 diabetes by 2050, and the total annual cost of\u0026nbsp;this\u0026nbsp;condition will be approximately $45 billion (3).\u003c/p\u003e\n\u003cp\u003eOver the last two decades, international (4-6)\u0026nbsp;and national (7) clinical research has established that sustained changes in lifestyle factors, including nutrition and exercise, can prevent up to 58% of type 2 diabetes cases or delay their onset by up to 14 years, particularly for individuals with prediabetes whose body weight is reduced by ≥5%. However, scaling up effective prevention health programs for reducing type 2 diabetes and/or obesity remains challenging, thereby limiting the programs reach and impact (8-11). Data from the United States show that despite massive collaborative effort of around 1,500 organisations, only about 0.4% of Americans at high risk of developing type 2 diabetes have joined a diabetes prevention program (8).\u003c/p\u003e\n\u003cp\u003eGovernments worldwide, including Australia, consider randomised controlled trials (RCTs) the accepted gold standard design for evaluating healthcare interventions, with the findings ultimately guiding clinical practice (12, 13). Irrespective of the chronic condition being targeted, data from the Australian New Zealand Clinical Trials Registry (ANZCTR) indicate that only 42% of all clinical trials are ever completed (14).The median sample size of public health trials conducted in 2020 was approximately 120 participants (interquartile range 58 to 755 participants), whereas the median sample size of all registered clinical trials was approximately 80 (interquartile range 33 to 200 participants) (14). These results underscore that even RCTs dedicated to developing efficient participant recruitment strategies face considerable challenges in quickly enrolling a few hundred participants to inform the scalability of a program (15, 16).\u003c/p\u003e\n\u003cp\u003eAlthough most of the information about the logistics, effectiveness and cost of various strategies used to recruit individuals into RCTs evaluating the feasibility and effectiveness of obesity and diabetes prevention programs comes from the U.S. (8, 9), some information comes from other countries, including Australia (17-19). For example, Bessell and colleagues (17) provided substantial detail on the logistics and costs of various strategies used to recruit Australian adults with prediabetes into a type 2 diabetes prevention RCT. Radio advertising followed by promoting the trial through healthcare networks were the most effective and cost-effective (i.e., low-effort high-yield) recruitment strategies, with each contributing 46% and 19%, respectively, to the final number of participants who were ultimately randomised. However, other RCTs that have recruited patients through healthcare networks, including General Practitioner (GP) clinics, have reported rates of success varying between ~10% and ~30% (7, 17, 19-21). Several factors that have been associated with higher referral rates from GP clinics include ensuring that the clinics have good awareness of the RCTs they are being asked to support, ensuring that they are aware of government-funded financial incentives aimed at supporting high-quality healthcare (e.g., for Australia, the Australian Government Quality Improvement Practice Incentive Program and the Practice Nurse Incentive Program) and that clinics use a streamlined patient management record system to assist in identifying eligible individuals (8, 20, 22, 23).\u003c/p\u003e\n\u003cp\u003eThis study aimed to build on the limited information that is currently available by characterising the relative effectiveness and cost of different strategies used to recruit high-risk individuals into a randomised control trial of an Australian Lifestyle Change Program (AUS2PREVENT) to prevent or delay type 2 diabetes in South Australia. We hypothesised that recruitment from GP clinics would be the most successful recruitment strategy.\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003e\u003cstrong\u003e\u003cem\u003eTrial design\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eA two-arm, parallel, stratified block-randomised controlled, community-based trial was used to evaluate the feasibility, acceptability, and the clinical and cost effectiveness of the ‘AUS2PREVENT program’ compared with ‘Usual Care’ to prevent or delay type 2 diabetes in South Australian’s, aged 18+ years, at high-risk of type 2 diabetes (i.e., scores of 12 or greater on the AUSDRISK (24)), and have at least one additional cardiometabolic risk marker (e.g., overweight/obese, high blood pressure, high lipids). Individuals who were already: diagnosed with type 1 or 2 diabetes or any other serious medical condition; pregnant or planning to become pregnant within the next 12 months; currently involved in a regular and vigorous exercise regime (e.g., training for competitive sport); receiving treatment to lower blood glucose levels; and who were unable or unwilling to give consent, were excluded from the trial. The trial comprised a recruitment phase via a two-staged screening process, followed by a 12-month intervention phase and a 12-month follow-up phase; \u003cstrong\u003eAdditional\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003eFile\u003c/strong\u003e\u003cstrong\u003e\u0026nbsp;1\u0026nbsp;\u003c/strong\u003edepicts the trial design, including the full inclusion and exclusion criteria.\u003c/p\u003e\n\u003cp\u003eThe trial protocol was approved by the\u0026nbsp;Southern Adelaide Clinical\u0026nbsp;Human Research Ethics Committee (SAC HREC); the ethics approval number is 344.18-HREC/18/SAC/416, and the trial is available at the Australian New Zealand Clinical Trials Registry (ANZCTR), Universal Trial Number U1111-1220-5636.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eRecruitment strategies\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eIndividuals living, working or attending a GP clinic in four Local Government Areas (LGAs) in metropolitan Adelaide were targeted through various strategies to find up to 600 eligible participants for the trial. It was planned that recruitment would take up to 12 months.\u0026nbsp;The demographic profile of the populations within the selected cities\u0026nbsp;was largely representative of\u0026nbsp;the broader South Australian profile (\u003cstrong\u003esee Additional File 2\u003c/strong\u003e).\u003c/p\u003e\n\u003cp\u003eRecruitment commenced November 16, 2021, and was concluded on December 22, 2022; the phasing of each recruitment strategy is depicted in \u003cstrong\u003eFigure 1\u003c/strong\u003e.\u003c/p\u003e\n\u003cp\u003eThe primary recruitment strategy was through GP clinics identified by the Adelaide Primary Health Network (PHN) and Diabetes SA stakeholder databases. Prior to engaging with any of the GP clinics, the Adelaide PHN incorporated electronic trial referral forms into patient management systems (i.e., Medical Director, Best Practice and Zedmed), which GPs were able to download, complete and forward to Diabetes SA. To inform the GP clinic staff about the trial, all identified clinics were contacted via email, fax, telephone or face-to-face visits by a member of the research team or a PHN practice facilitator. Recruitment posters and flyers were distributed to clinics that received a face-to-face visit to promote the trial in their waiting and consult rooms. All the recruitment material directed interested health professionals to the Trial Co-ordinator and/or the AUS2PREVENT Trial website (25). The website contained a recorded presentation about the trial, how GPs could refer potential participants, and links to the relevant participant information sheet and consent form (PICF).\u003c/p\u003e\n\u003cp\u003eGPs were not reimbursed by the research team for referring patients to the trial; however, they were eligible for reimbursement related to performing type 2 diabetes screening clinical tests through the Australian Government’s Quality Improvement Practice Incentive Program (26).\u003c/p\u003e\n\u003cp\u003eTo facilitate self-referrals, additional channels were used across the 12-month recruitment period, including radio, online media (e.g., Facebook, Instagram, and webpages), newsletters/noticeboards, newspaper articles, and emails or member-orientated magazines to individuals through health and community organisations within Diabetes SA’s collaborative networks.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eScreening processes\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSt\u003c/strong\u003e\u003cstrong\u003eage 1 pre-screening\u003c/strong\u003e: Individuals interested in or referred to the trial were directed to an online pre-screening survey (via the Qualtrics platform), which took ~15 minutes to complete. Individuals who completed the survey were emailed a copy of the PICF by the Trial team. Individuals were then called to ensure that they understood the expectations of being a trial participant and to give them the opportunity to ask questions. Individuals were instructed to complete and return (via email) all the forms.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStage 2 screening\u003c/strong\u003e: Consenting individuals who met the Stage 1 screening criteria were sent a referral letter to see their GP for clinical investigations to confirm their eligibility. A copy of the signed consent was forwarded to the individual’s GP (or clinic) and was accompanied by a letter outlining their patient’s expression of interest in the trial. The letter also outlined the specific observations the trial team required to determine eligibility. Once results from a GP were received, the individual’s full eligibility was confirmed.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eData collection and analysis\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eStaff involved in all aspects of recruitment were asked to calculate the time they spent (note that some calculations are based on best estimates of time spent) doing each of the following activities: development of recruitment collateral, organising promotional strategies, and moving each individual through the screening process. For each individual who expressed interest in the trial and commenced the screening process, interactions via email and phone (including attempts at contacting them via phone) were recorded in a purpose-built database. The reasons individuals provided for withdrawing from the trial were also recorded. Individuals who did not officially withdraw but who did not complete all screening stages were recorded as lost to follow-up.\u003c/p\u003e\n\u003cp\u003eThe pre-screening survey included a question asking individuals to report where they had heard about the trial.\u003c/p\u003e\n\u003cp\u003eFor each recruitment strategy, the number of expressions of interest, the number of people booked for an onsite screening, and the number of randomised participants were collated. The direct cost of implementing each recruitment strategy was recorded. The time spent by staff per recruitment channel was not calculated, but the time spent by staff to perform all aspects of the recruitment and screening process was calculated based on their records of time spent per recruitment activity. Importantly, any costs associated with the Adelaide PHN staff who supported our recruitment from GP clinics were not included in our results.\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003e\u003cstrong\u003e\u003cem\u003eProtocol amendments as a result of process evaluation during the screening process\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAs a result of slower than desired recruitment, two protocol amendments were sought and approved by the SAC HREC during the recruitment period. In brief, the first amendment (May 24, 2022) related to the expansion of the participant catchment area from the original four LGAs to a total of 11 LGAs. The first amendment was sought because 82 individuals who met most of the inclusion criteria during Stage 1 of the screening process lived or worked in suburbs surrounding the original four LGAs. This amendment increased the total pool of potentially eligible individuals from 1,625 (i.e., those identified from the 76 GP clinics in the original four LGAs) to approximately 25,000.\u003c/p\u003e\n\u003cp\u003eThe second amendment (October 25, 2022) related to lowering the prediabetes inclusion criteria because many individuals had HbA1c and/or fasting blood glucose values slightly lower than the current lower cut-off values recommended by the Australian Clinical Guidelines for the diagnosis of prediabetes (i.e., ≥6.0 to ≤6.4% for HbA1c and ≥6.1 to ≤6.9 mmol/L for FBG) (27). Hence, the decision was made to amend the prediabetes criteria to those recommended by the American Diabetes Association (ADA) guidelines (i.e., ≥5.7% to ≤6.4% for HbA1c and ≥5.6 to ≤6.9 mmol/L for FBG) (23). These cut-off values are also in line with the prediabetes cut-off values recommended by the International Expert Committee (IEC) and Australian diabetes experts (24-26). This enabled 22 individuals who were ineligible at the end of screening Stage 2 to be considered for randomisation.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eNumber and characteristics of individuals recruited and screened\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe flow of individuals through the two staged screening process is depicted in\u003cstrong\u003e\u0026nbsp;Figure 2\u003c/strong\u003e.\u003c/p\u003e\n\u003cp\u003eReasons for survey non-completion (N=796) were not reported. Individuals who completed Stage 1 screening were predominantly female (68%), on average (±SD) aged 48±12 years, had a body mass index of 33.1±7.2 kg/m\u003csup\u003e2\u003c/sup\u003e, an AUSDRISK score of 16.6±5.3, and 1.2±2.1 chronic medical conditions. Reported reasons for withdrawing at Stage 1 included time restraints related to work or personal commitments (n=18), changes in mind (n=37), recent blood results, other health conditions, or starting a new medication that excluded them from the trial (n=8). The reasons for withdrawing at Stage 2 included no longer having time (n=5), no longer being interested in the trial (n=1), unexpected surgery (n=1), and starting treatment with another health professional (n=2).\u003c/p\u003e\n\u003cp\u003eThe 85 individuals who were eligible after completing Stage 2 screening were predominantly female (68%), were aged 54±12 years, had a body mass index of 33.2±6.5 kg/m\u003csup\u003e2\u003c/sup\u003e, an AUSDRISK score of 19.8±4.5, 1.5±2.1 chronic medical conditions, an HbA1c of 5.8±0.3%, a fasting blood glucose of 5.8±0.4 mmol/L, a fasting total cholesterol of 5.1±1.0 mmol/L, a fasting triglyceride of 1.7±1.4 mmol/L, a fasting low-density lipoprotein of 3.0±0.9 mmol/L, and a fasting high-density lipoprotein of 1.3±0.3 mmol/L. However, 7 of the eligible individuals withdrew interest because of a change in personal commitments, which they felt would prevent them from abiding by the trial protocol (n=5), or because of a delay in commencing the intervention phase (n=2).\u003c/p\u003e\n\u003cp\u003eA total of 67 individuals were enrolled in the intervention phase of the trial and randomised into usual care (n=35) or lifestyle change (n=32); this represents approximately 11% of the 587 who completed Stage 1 screening, 39% of the 171 who completed Stage 2 screening, and 4% of everyone who expressed interest in the trial.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eRelative effectiveness of the various recruitment channels\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable 1\u003c/strong\u003e summarisesthe relative effectiveness of the various channels used to recruit participants.\u0026nbsp;A more detailed version of this table can be found in \u003cstrong\u003eAdditional File 3\u003c/strong\u003e.\u0026nbsp;Among\u0026nbsp;the 587 individuals who reported which recruitment channel they had come through, the greatest percentage came from\u0026nbsp;the\u0026nbsp;radio, followed by email and then online media (i.e., 48% vs 26% vs 16%,\u0026nbsp;respectively). The same three channels also yielded the greatest number of individuals who were eventually enrolled and randomised (i.e.,\u0026nbsp;21% vs 23% vs 11%, respectively). Only 4 individuals reported being referred by their GP or learning from flyers/messages in GP clinics.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eStaff time spent on the various recruitment channels\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eTable 1 includes the direct cost of promoting the trial via the different recruitment strategies; personnel and indirect business costs are excluded. The total direct cost of promoting the trial was $40,874. In terms of cost per promotion channel (excluding staff time), many channels had low or no costs, as they were digital – i.e., emails, digital articles, and word of mouth. In contrast, the cost of promotion was greatest for radio, followed by online media, GPs/GP clinics, and then flyers distributed to public councils and placed on other public noticeboards.\u003c/p\u003e\n\u003cp\u003eRegarding direct costs associated with staff, approximately 1 full-time equivalent (FTE) over a period of approximately 2.5 years was required to develop recruitment collateral, organise promotional strategies, and move individuals through the two-staged screening process; this was determined from a mixture of recorded and estimated time per activity. Of this 1 FTE, approximately 0.15 FTE related to the creation of promotional material and conversations with GPs and/or Practice Nurses, 0.01 FTE related to the development of promotional collateral for radio and targeted emails, and the remaining 0.8 FTE related to moving individuals through the two screening stages to determine their eligibility.\u003c/p\u003e\n\u003cp\u003e[Table 1 should be inserted here]\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eAfter 12 months of recruiting, 67 high-risk South Australians were screened as eligible for enrolment in this community-based randomised control trial testing an evidence-based type 2 diabetes prevention program. This figure represents 4% of all individuals who expressed interest in the trial, 11% of the 587 who completed Stage 1 screening, and 39% of the 171 who completed Stage 2 screening. Radio, followed by email and online media, were the key recruitment strategies that generated the greatest interest in the trial and accounted for the 67 individuals who were ultimately enrolled and randomised into one of the two trial treatments.\u0026nbsp;Despite the trial team engaging with the local Adelaide PHN and 279 GP clinics across metropolitan South Australia, only four participants came from GP or health professional referrals. With respect to the costs associated with recruitment, direct costs related to staff were the most expensive aspect of recruitment, but these costs were similar across the different strategies. Excluding staff costs,\u0026nbsp;the greatest expenditure was related to\u0026nbsp;promotional collateral used for radio,\u0026nbsp;followed by online media\u0026nbsp;and GP clinics.\u003c/p\u003e\n\u003cp\u003eThe current trial recruited only 11% of the targeted 600 individuals over 12 months. Importantly, we did not extend the recruitment period to minimise the risk of 85 eligible participants withdrawing before starting the intervention. Closing the recruitment on time proved to be a wise decision, as we observed further attrition of 18 individuals who could not be contacted or withdrew due to other commitments (i.e., work or travel). Despite not achieving our original target, our sample size was comparable with the median sample size reported in the 2020 ANZCTR for all public health trials, which is 80 participants (14). More importantly, our findings show that direct spending of approximately $40,874 to promote a type 2 prevention trial via eight different recruitment channels, coupled with the direct and indirect business costs of employing 1 full-time equivalent (FTE) over a period of approximately 2.5 years, ultimately identified 67 eligible South Australians. While we considered calculating and comparing the costs of recruitment at the per participant randomised level (as has been previously reported by others (17, 19))\u0026nbsp;doing so can lead to misleading conclusions because RCTs have used different designs, and the costs (especially staff direct and indirect costs) related to recruitment tend to differ considerably between organisations. What is critically important is that organisations planning to implement scalable prevention programs understand the program features and logistics that are cost-effective.\u003c/p\u003e\n\u003cp\u003eConsistent with our findings, previous preventive health trials reported that the absolute number of people referred from GPs was lower than those referred from other strategies (18, 19, 28). While we hoped that notifying GP clinics about the Australian Government Quality Improvement Practice Incentive Program would help support GP clinics to refer individuals into our trial, financial incentives appear to be underutilised across Australia for a variety of reasons, including a lack of awareness of all available practice incentives and issues related to organisational readiness to support the delivery of interventions (29). Insights from the implementation research of community preventive health programs suggest that GP/health professional referrals are highest when there is widespread public awareness about a program and its benefits, and the program is well integrated into multiple systems within the primary healthcare setting; achieving this usually takes several years (28, 30-34).\u003c/p\u003e\n\u003cp\u003eData from the US (33, 35-37), the UK (32, 34) and Australia (10, 38, 39) also indicate that the views and attitudes of GPs or GP clinic staff contribute to the level at which individuals are referred to trials evaluating preventive health interventions. Some health professionals may lack knowledge about health conditions, others may not perceive the evidence base behind the intervention as credible, and some may not believe that the intervention is tailored enough to their patients’ needs (38). Some GPs may be reluctant to refer their patients to a public health trial because of ethical concerns with the randomisation process, even if both the new treatment and usual care can benefit a participant (32, 40-42). Others consider promoting preventive health trials or referring individuals into them as not their primary role (40) and others may find it challenging to have conversations for a variety of reasons (38). In addition, structural barriers that shape GP workloads can also prevent GPs from referring individuals to preventive health interventions (32). These barriers may include a lack of time due to already heavy workloads (43); a lack of clear processes in how to coordinate the referral of high-risk individuals to such programs; a lack of demand or buy in from potentially eligible patients they have on their clinic database (39); fluctuating volumes of individuals coming to see the GP and, when they do see their GP, attending for a specific reason; a lack of high-quality promotional material that can be placed within clinic waiting rooms or used for direct messaging to inform individuals of the importance of detection and early intervention of type 2 diabetes; and financial incentives that do not recoup the true cost (including oncosts) of supporting referrals (39).\u003c/p\u003e\n\u003cp\u003eA major limitation of the current trial was that, regardless of the recruitment strategy, many individuals did not complete Stage 1 of screening (i.e., the online pre-screening survey). Unfortunately, neither we nor others (16-18) have been able to confirm why high numbers of individuals self-determine that they are not eligible for clinical trials. For future implementation of preventive health interventions, understanding the reasons that individuals express interest but then drop out of a program is critical, as it will assist with tailoring messages to effectively engage a high number of the target audience that will benefit the most.\u003c/p\u003e"},{"header":"Conclusions","content":"\u003cp\u003eThese findings demonstrate that timely and cost-effective recruitment of people into a trial testing a preventive health program requires a recruitment strategy that is adaptive, multi-channelled, location-specific and appropriate for the population being targeted and the trial design being used. A high level of co-ordination between key health organisations, time to build awareness and trust, and a significant trial marketing and communication budget are essential to engage high-risk individuals in prevention programs to reduce type 2 diabetes or other related chronic conditions. Further research is needed to understand the experiences and perspectives of individuals who engage in preventive health interventions compared with those who do not. In addition, understanding the perspectives of GPs, GP clinic managers and other staff within the Primary Health Network regarding the barriers they experience in referring high-risk individuals to gold-standard randomised control trials is needed, as these trials are important for determining the most clinical and cost-effective preventive health interventions.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003e\u003cstrong\u003e\u003cem\u003eANZCTR;\u003c/em\u003e\u003c/strong\u003e Australian New Zealand Clinical Trial Register\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eAUSDRISK:\u003c/em\u003e\u003c/strong\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003eAustralian type 2 diabetes risk assessment tool\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eFBG:\u003c/em\u003e\u003c/strong\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003efasting blood glucose\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eFTE:\u003c/em\u003e\u003c/strong\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003eFull-Time Equivalent\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eGP:\u003c/em\u003e\u003c/strong\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003eGeneral Practitioner\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eHbA1c:\u003c/em\u003e\u003c/strong\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003eHaemoglobin A1c\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eLGA:\u003c/em\u003e\u003c/strong\u003e Local Government Area\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eNDSS:\u0026nbsp;\u003c/em\u003e\u003c/strong\u003eNational Diabetes Services Scheme\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003ePHN:\u003c/em\u003e\u003c/strong\u003e Primary Health Network\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003ePICF:\u003c/em\u003e\u003c/strong\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003eParticipant Information Sheet and Consent Form\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eRCT:\u0026nbsp;\u003c/em\u003e\u003c/strong\u003eRandomised control trial\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eRACGP:\u003c/em\u003e\u003c/strong\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003eThe Royal Australian College of General Practitioners\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eSAC HREC:\u003c/em\u003e\u003c/strong\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003eSouthern Adelaide Clinical Human Research Ethics Committee\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe study protocol was approved by the Southern Adelaide Clinical Human Research Ethics Committee (SAC HREC), ethics approval number 344.18-HREC/18/SAC/416. The PICF was available online for potential participants to read prior to completing the screening questionnaire. Eligible individuals (see\u0026nbsp;\u003cstrong\u003eAdditional File\u003c/strong\u003e\u003cstrong\u003e\u0026nbsp;1\u003c/strong\u003e for criteria) were emailed a copy of the PICF by the Trial team. Individuals were then called to ensure that they understood the expectations of being a trial participant and to give them the opportunity to ask questions. Individuals were instructed to complete and return (via email) all the forms.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eData sharing is not applicable to this article, as no datasets were generated or analysed during the current study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare that they have no conflicts of interest.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAuthors HA, CP, SU and PW received support from Diabetes SA for evaluating the trial outcomes.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors' contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll the authors were involved in the planning stages of the trial design. AK, NLM and FB led the analysis and wrote the manuscript. HA, CP, SU and PW interpreted the data for the outcomes presented in this paper. All the authors read and approved the final manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors would like to acknowledge Diabetes SA for funding the trial and the support of the Adelaide Primary Health Network, who assisted with the identification of GP clinics within the trial areas. We also thank all the general practice staff who assisted us in our recruitment phase and the individuals who expressed interest in and contributed to this research.We would also like to thank Dr.\u0026nbsp;Amy Hutchison (University of Adelaide, Australia) for\u0026nbsp;screening their existing participant databases andemailing trial information to those who may be eligible.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eG. B. D. Diabetes Collaborators. Global, regional, and national burden of diabetes from 1990 to 2021, with projections of prevalence to 2050: a systematic analysis for the Global Burden of Disease Study 2021. Lancet. 2023;402:10397:203-34.\u003c/li\u003e\n\u003cli\u003eParker ED, Lin J, Mahoney T, Ume N, Yang G, Gabbay RA, et al. Economic Costs of Diabetes in the U.S. in 2022. Diabetes Care. 2023;47:1:26-43.\u003c/li\u003e\n\u003cli\u003eDiabetes Australia. State of the Nation Report 2024. The Diabetes Epidemic in Australia. 2024. Accessed. https://www.diabetesaustralia.com.au/wp-content/uploads/State-of-the-Nation-2024-Diabetes-Australia.pdf.\u003c/li\u003e\n\u003cli\u003eLindstr\u0026ouml;m J, Peltonen M, Eriksson J, Ilanne-Parikka P, Aunola S, Kein\u0026auml;nen-Kiukaanniemi S, et al. Improved lifestyle and decreased diabetes risk over 13 years: long-term follow-up of the randomised Finnish Diabetes Prevention Study (DPS). Diabetologia. 2013;56:2:284-93.\u003c/li\u003e\n\u003cli\u003eKnowler WC, Fowler SE, Hamman RF, Christophi CA, Hoffman HJ, Diabetes Prevention Program Research G. 10-year follow-up of diabetes incidence and weight loss in the Diabetes Prevention Program Outcomes Study. 2009;374:1677-86.\u003c/li\u003e\n\u003cli\u003eHemmingsen B, Gimenez-Perez G, Mauricio D, Roque IFM, Metzendorf MI, Richter B. Diet, physical activity or both for prevention or delay of type 2 diabetes mellitus and its associated complications in people at increased risk of developing type 2 diabetes mellitus. The Cochrane database of systematic reviews. 2017;12:Cd003054.\u003c/li\u003e\n\u003cli\u003eLaatikainen T, Dunbar JA, Chapman A, Kilkkinen A, Vartiainen E, Heistaro S, et al. Prevention of type 2 diabetes by lifestyle intervention in an Australian primary health care setting: Greater Green Triangle (GGT) Diabetes Prevention Project. BMC Public Health. 2007;7:249.\u003c/li\u003e\n\u003cli\u003eAckermann RT, O\u0026rsquo;Brien MJ. Evidence and Challenges for Translation and Population Impact of the Diabetes Prevention Program. Current Diabetes Reports. 2020;20:3.\u003c/li\u003e\n\u003cli\u003eEly EK, Gruss SM, Luman ET, Gregg EW, Ali MK, Nhim K, et al. A National Effort to Prevent Type 2 Diabetes: Participant-Level Evaluation of CDC\u0026rsquo;s National Diabetes Prevention Program. Diabetes Care. 2017;40:10:1331-41.\u003c/li\u003e\n\u003cli\u003eDunbar JA. Diabetes Prevention in Australia: 10 Years Results and Experience. Diabetes Metab J. 2017;41:3:160-7.\u003c/li\u003e\n\u003cli\u003eDelahanty LM, Nathan DM. Implications of the diabetes prevention program and Look AHEAD clinical trials for lifestyle interventions. J Am Diet Assoc. 2008;108:4 Suppl 1:S66-72.\u003c/li\u003e\n\u003cli\u003eAlsan M, Finkelstein AN. Beyond Causality: Additional Benefits of Randomized Controlled Trials for Improving Health Care Delivery. Milbank Q. 2021;99:4:864-81.\u003c/li\u003e\n\u003cli\u003eNational Health and Medical Research Council. A guide to the development, implementation and evaluation of clinical practice guidelines. 1999. Accessed 07 February 2025. https://www.nhmrc.gov.au/sites/default/files/images/a-guide-to-the-development-and-evaluation-of-clinical-practice-guidelines.pdf.\u003c/li\u003e\n\u003cli\u003eWillson ML SA, Aberoumand M, Williams JG, Hunter KE, Barba A, Webster AC, Askie LM, Simes RJ. Latest update of the clinical trials landscape in Australia 2006 \u0026ndash; 2020. 2022. Accessed 11 July 2024. https://doi.org/10.25910/t9n1-bm45.\u003c/li\u003e\n\u003cli\u003eMcDonald AM, Knight RC, Campbell MK, Entwistle VA, Grant AM, Cook JA, et al. What influences recruitment to randomised controlled trials? A review of trials funded by two UK funding agencies. Trials. 2006;7:9.\u003c/li\u003e\n\u003cli\u003eRobinson JL, Fuerch JH, Winiewicz DD, Salvy SJ, Roemmich JN, Epstein LH. Cost effectiveness of recruitment methods in an obesity prevention trial for young children. Preventive Medicine. 2007;44:6:499-503.\u003c/li\u003e\n\u003cli\u003eBessell E, Markovic TP, Caterson ID, Hendy C, Burk J, Picone T, et al. Cost-effectiveness analysis of recruitment strategies in a large diabetes prevention trial conducted across two sites in Sydney, Australia. Contemporary Clinical Trials. 2024;137:107421.\u003c/li\u003e\n\u003cli\u003eHsu MS, Harper C, Gibson AA, Sweeting AN, McBride J, Markovic TP, et al. Recruitment strategies for a randomised controlled trial comparing fast versus slow weight loss in postmenopausal women with obesity\u0026mdash;The tempo diet trial. Healthcare. 2018;6:3:76.\u003c/li\u003e\n\u003cli\u003eMiller EG, Nowson CA, Dunstan DW, Kerr DA, Solah V, Menzies D, et al. Recruitment of older adults with type 2 diabetes into a community-based exercise and nutrition randomised controlled trial. Trials. 2016;17:1:467.\u003c/li\u003e\n\u003cli\u003eParker S, Tran A, Saito S, McNamara C, Denney-Wilson E, Nutbeam D, et al. Exploring organisational readiness to implement a preventive intervention in Australian general practice for overweight and obese patients: key learnings from the HeLP-GP trial. Australian Journal of Primary Health. 2024;30:1.\u003c/li\u003e\n\u003cli\u003eBarnett AG, Glasziou P. Target and actual sample sizes for studies from two trial registries from 1999 to 2020: an observational study. BMJ Open. 2021;11:12:e053377.\u003c/li\u003e\n\u003cli\u003eAfzali HHA, Karnon J, Beilby J, Gray J, Holton C, Banham D. Practice nurse involvement in general practice clinical care: policy and funding issues need resolution. Australian Health Review. 2014;38:3:301-5.\u003c/li\u003e\n\u003cli\u003eAfzali HHA, Karnon J, Gray J, Beilby J. A model-based evaluation of collaborative care in management of patients with type 2 diabetes in Australia: an initial report. Australian Health Review. 2012;36:3:258-63.\u003c/li\u003e\n\u003cli\u003eDepartment of Health. Australian type 2 diabetes risk assessment tool (AUSDRISK) 2016; Accessed 20 July 2018. http://www.health.gov.au/preventionoftype2diabetes.\u003c/li\u003e\n\u003cli\u003eDiabetes SA. AUS2PREVENT Trial 2021; Accessed 15 November 2021. https://www.diabetessa.com.au/Web/AUS2PREVENT.\u003c/li\u003e\n\u003cli\u003eThe Royal Australian College of General Practitioners. Practice Incentives Program Quality Improvement Incentive (PIP QI) fact sheet. 2020. Accessed 23 June 2020.\u003c/li\u003e\n\u003cli\u003eThe Royal Australian College of General Practitioners. Management of type 2 diabetes: A handbook for general practice. Defining and diagnosing type 2 diabetes 2024; Accessed 11 October 2024. https://www.racgp.org.au/clinical-resources/clinical-guidelines/key-racgp-guidelines/view-all-racgp-guidelines/diabetes/defining-and-diagnosing-type-2-diabetes.\u003c/li\u003e\n\u003cli\u003eO\u0026apos;Hara BJ, Eggins D, Phongsavan P, Milat AJ, Bauman AE, Wiggers J. Piloting proactive marketing to recruit disadvantaged adults to a community-wide obesity prevention program. Public Health Res Pract. 2015;25:e2521521.\u003c/li\u003e\n\u003cli\u003eKPMG. Effectiveness Review of General Practice Incentives. Sydney, New South Wales. 2024. Accessed 04 April 2025.\u003c/li\u003e\n\u003cli\u003eGriffith University My health for life Evaluation Team. My health for life Program Evaluation Report. Evaluation findings from inception to 31 December 2019. 2020. Accessed 06 November 2024.\u003c/li\u003e\n\u003cli\u003eVictorian government, Diabetes Victoria. Life! Program Evaluation Overview 2022\u0026ndash;2023. Victoria, Australia: Department of Health. 2024. Accessed 09 February 2021.\u003c/li\u003e\n\u003cli\u003eFletcher B, Gheorghe A, Moore D, Wilson S, Damery S. Improving the recruitment activity of clinicians in randomised controlled trials: a systematic review. BMJ Open. 2012;2:1:e000496.\u003c/li\u003e\n\u003cli\u003eAlva ML, Chakkalakal RJ, Moin T, Galaviz KI. The Diabetes Prevention Gap And Opportunities To Increase Participation In Effective Interventions. Health Aff (Millwood). 2022;41:7:971-9.\u003c/li\u003e\n\u003cli\u003eStokes J, Gellatly J, Bower P, Meacock R, Cotterill S, Sutton M, et al. Implementing a national diabetes prevention programme in England: lessons learned. BMC health services research. 2019;19:1:991-.\u003c/li\u003e\n\u003cli\u003eHalley MC, Petersen J, Nasrallah C, Szwerinski N, Romanelli R, Azar KMJ. Barriers and Facilitators to Real-world Implementation of the Diabetes Prevention Program in Large Healthcare Systems: Lifestyle Coach Perspectives. Journal of General Internal Medicine. 2020;35:6:1684-92.\u003c/li\u003e\n\u003cli\u003eNhim K, Khan T, Gruss S, Wozniak G, Kirley K, Schumacher P, et al. Facilitators to referrals to CDC\u0026apos;s National Diabetes Prevention Program in primary care practices and pharmacies: DocStyles 2016\u0026ndash;2017. Preventive Medicine. 2021;149:106614.\u003c/li\u003e\n\u003cli\u003eTseng E, Greer RC, O\u0026apos;Rourke P, Yeh HC, McGuire MM, Albright AL, et al. National Survey of Primary Care Physicians\u0026apos; Knowledge, Practices, and Perceptions of Prediabetes. J Gen Intern Med. 2019;34:11:2475-81.\u003c/li\u003e\n\u003cli\u003eThe Royal Australian College of General Practitioners. Views and attitudes towards physical activity and nutrition counselling in general practice: National survey report 2019. 2019.\u003c/li\u003e\n\u003cli\u003eTerry D, Hills D, Bradley C, Govan L. Nurse‐led clinics in primary health care: A scoping review of contemporary definitions, implementation enablers and barriers and their health impact. Journal of clinical nursing. 2024;33:5:1724-38.\u003c/li\u003e\n\u003cli\u003eMoffat KR, Shi W, Cannon P, Sullivan F. Factors associated with recruitment to randomised controlled trials in general practice: a systematic mixed studies review. Trials. 2023;24:1:90.\u003c/li\u003e\n\u003cli\u003eHunt CJ, Shepherd LM, Andrews G. Do doctors know best? Comments on a failed trial. Med J Aust. 2001;174:3:144-6.\u003c/li\u003e\n\u003cli\u003eLockery JE, Collyer TA, Abhayaratna WP, Fitzgerald SM, McNeil JJ, Nelson MR, et al. Recruiting general practice patients for large clinical trials: lessons from the Aspirin in Reducing Events in the Elderly (ASPREE) study. Medical Journal of Australia. 2019;210:4:168-73.\u003c/li\u003e\n\u003cli\u003eDiabetes.co.uk: the global diabetes community. GPs incentivised for referrals following low Diabetes Prevention Programme enrolment 2017; Accessed 01 November 2024. https://www.diabetes.co.uk/news/2017/aug/gps-incentivised-for-referrals-following-low-diabetes-prevention-programme-enrolment-97146663.html.\u003c/li\u003e\n\u003c/ol\u003e"},{"header":"Table","content":"\u003cp\u003e\u003cstrong\u003eTable\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003e1\u003c/strong\u003e Cost and reach of the recruitment channels used in the AUS2PREVENT trial.\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"101%\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"2\" valign=\"top\" style=\"width: 15px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eRecruitment Channel \u0026amp; Cost (excludes personnel costs)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"6\" valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003e\u003cstrong\u003ePer Recruitment Channel\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 12px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eNumber of times used\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 21px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eReach\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eIndividual expressions of interest\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e(N)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eScreened eligible at Stage 1\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e(N)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eScreened eligible at Stage 2\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e(N)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eRandomised\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e(N)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 15px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eRadio: $39,033\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12px;\"\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 21px;\"\u003e\n \u003cp\u003e\u0026gt;543,000 individuals\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13px;\"\u003e\n \u003cp\u003e283\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11px;\"\u003e\n \u003cp\u003e84\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11px;\"\u003e\n \u003cp\u003e32\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14px;\"\u003e\n \u003cp\u003e21\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 15px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"6\" valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eABC Radio\u003cem\u003e\u0026nbsp;-\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003cem\u003eYielded a total of 4 expressions of interest and 2 individuals who were eligible at Stage 1.\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"3\" valign=\"top\" style=\"width: 15px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"6\" valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eTriple M and SAFM\u003cem\u003e\u0026nbsp;-\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003cem\u003eYielded a total of 49 (i.e. 28+21) expressions of interest and a total of 14 (6+8) individuals who were eligible at Stage 1.\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"6\" valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eRadio Italia\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003cstrong\u003e\u003cem\u003e-\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003cem\u003eYielded a total of 0 expressions of interest but some may not have stated this channel.\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"6\" valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eNot stated\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003cstrong\u003e\u003cem\u003e-\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003cem\u003eYielded a total of 230 expressions of interest and a total of 68 individuals who were eligible at Stage 1.\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 15px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eEmail: $0\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12px;\"\u003e\n \u003cp\u003e~7\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 21px;\"\u003e\n \u003cp\u003eEstimated to have reached \u0026gt;10,000 individuals\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13px;\"\u003e\n \u003cp\u003e151\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11px;\"\u003e\n \u003cp\u003e61\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11px;\"\u003e\n \u003cp\u003e25\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14px;\"\u003e\n \u003cp\u003e23\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 15px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"6\" valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eDiabetes SA \u0026lsquo;e-News\u0026rsquo;\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003cstrong\u003e\u003cem\u003e-\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003cem\u003eYielded a total of 21 expressions of interest and a total of 10 individuals who were eligible at Stage 1.\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 15px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"6\" valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eNational Diabetes Services Scheme (NDSS) email\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003cstrong\u003e\u003cem\u003e-\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003cem\u003eYielded a total of 29 expressions of interest and a total of 10 individuals who were eligible at Stage 1.\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 15px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"6\" valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eExisting databases\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003cstrong\u003e\u003cem\u003e-\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003cem\u003eYielded a total of 12 expressions of interest and a total of 8 individuals who were eligible at Stage 1.\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 15px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"6\" valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eNot stated\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003cstrong\u003e\u003cem\u003e-\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003cem\u003eYielded a total of 89 expressions of interest and a total of 33 individuals who were eligible at Stage 1.\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 15px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eOnline media (e.g., Facebook, Instagram, webpages):\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003e$1,029\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12px;\"\u003e\n \u003cp\u003e~16\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 21px;\"\u003e\n \u003cp\u003eEstimated to have reached few hundred individuals\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13px;\"\u003e\n \u003cp\u003e91\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11px;\"\u003e\n \u003cp\u003e23\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11px;\"\u003e\n \u003cp\u003e12\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14px;\"\u003e\n \u003cp\u003e11\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 15px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"6\" valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eWebpage\u003c/strong\u003e\u003cstrong\u003e\u003cem\u003e\u0026nbsp;-\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003cem\u003eYielded a total of 21 expressions of interest and a total of 7 individuals who were eligible at Stage 1.\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 15px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"6\" valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eSocial media\u003c/em\u003e\u003c/strong\u003e\u003cstrong\u003e\u003cem\u003e\u0026nbsp;-\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003cem\u003eYielded a total of 30 expressions of interest and a total of 9 individuals who were eligible at Stage 1.\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 15px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"6\" valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eNot stated\u003c/em\u003e\u003c/strong\u003e\u003cstrong\u003e\u003cem\u003e\u0026nbsp;-\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003cem\u003eYielded a total of 40 expressions of interest and a total of 7 individuals who were eligible at Stage 1.\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 15px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eUnsure:\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e$ unknown\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12px;\"\u003e\n \u003cp\u003eUnknown\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 21px;\"\u003e\n \u003cp\u003eUnknown\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13px;\"\u003e\n \u003cp\u003e14\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11px;\"\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11px;\"\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14px;\"\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 15px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"6\" valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003eReferral pathway not stated as individuals could not remember how they heard about the trial or did not want to specify where they heard about it.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 15px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eFamily member\u003c/strong\u003e\u003cstrong\u003e/ colleague/ Friend: $0\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12px;\"\u003e\n \u003cp\u003eContinuous\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 21px;\"\u003e\n \u003cp\u003eUnknown\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13px;\"\u003e\n \u003cp\u003e15\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11px;\"\u003e\n \u003cp\u003e7\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11px;\"\u003e\n \u003cp\u003e5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14px;\"\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 15px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"6\" valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003eIndirect referral from someone in the individual\u0026rsquo;s life who received information about the trial through one of the alternate referral sources.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 15px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eNewspaper: $0\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12px;\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 21px;\"\u003e\n \u003cp\u003eUnknown\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13px;\"\u003e\n \u003cp\u003e13\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11px;\"\u003e\n \u003cp\u003e6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11px;\"\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14px;\"\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 15px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"6\" valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eBoomer section of The Advertiser\u003c/strong\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e-\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003cem\u003eYielded a total of 2 expressions of interest and a total of 1 individual who was eligible at Stage 1.\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 15px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"6\" valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eIndependent Lifestyle section of The Sunday Mail\u003c/strong\u003e\u003cstrong\u003e\u003cem\u003e\u0026nbsp;-\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003cem\u003eYielded a total of 6 expressions of interest and a total of 3 individuals who were eligible at Stage 1.\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 15px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"6\" valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eNot stated\u003c/em\u003e\u003c/strong\u003e\u003cstrong\u003e\u003cem\u003e\u0026nbsp;-\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003cem\u003eYielded a total of 5 expressions of interest and a total of 2 individuals who were eligible at Stage 1.\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 15px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eDiabetes SA: $0\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12px;\"\u003e\n \u003cp\u003e\u0026gt;5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 21px;\"\u003e\n \u003cp\u003eEstimated to have reached over a few hundred individuals\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13px;\"\u003e\n \u003cp\u003e12\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11px;\"\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 15px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"6\" valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eWorld Diabetes Day\u003c/strong\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003e\u003cem\u003e-\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003cem\u003eYielded a total of 1 expression of interest and a total of 0 individuals who were eligible at Stage 1.\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 15px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"6\" valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eClinical delivery\u003c/strong\u003e\u003cstrong\u003e\u003cem\u003e\u0026nbsp;-\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003cem\u003eYielded a total of 1 expression of interest and a total of 1 individual who was eligible at Stage 1.\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 15px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"6\" valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eMyLife Magazine\u0026nbsp;\u003c/strong\u003e-\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003cem\u003eYielded a total of 0 expressions of interest but some may not have stated this channel.\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 15px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"6\" valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eMiscellaneous\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003e\u003cem\u003e-\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003cem\u003eYielded a total of 10 expressions of interest and a total of 2 individuals who were eligible at Stage 1.\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 15px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eGP Clinics: $647\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12px;\"\u003e\n \u003cp\u003eContinuous\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 21px;\"\u003e\n \u003cp\u003eEstimated to have reached \u0026gt;25,000 patients with prediabetes from across 279 clinics in the targeted LGAs.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13px;\"\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11px;\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 15px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"6\" valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003eA total of GP 279 clinics in the trial areas were contacted by one of the Trial team. Of these, 252 clinics were provided with information on the trial including referral pathways and the criteria for eligible individuals.\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 15px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eNewsletter/ noticeboard: $165\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12px;\"\u003e\n \u003cp\u003e\u0026gt;3 times\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 21px;\"\u003e\n \u003cp\u003eEstimated to have reached over a few hundred individuals\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13px;\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 15px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"6\" valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eAdelaide PHN\u003c/strong\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e-\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003cem\u003eYielded a total of 0 expressions of interest but some may not have stated this channel.\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 15px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"6\" valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eGPEx\u003c/strong\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e-\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003cem\u003eYielded a total of 0 expressions of interest but some may not have stated this channel.\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 15px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"6\" valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eThe Royal Australian College of General Practitioners\u0026nbsp;\u003c/strong\u003e-\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003cem\u003eYielded a total of 0 expressions of interest but some may not have stated this channel.\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 15px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"6\" valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eCommunity noticeboard/newsletter\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003e\u003cem\u003e-\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003cem\u003eYielded a total of 2 expressions of interest and a total of 1 individual who was eligible at Stage 1.\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\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":"pilot-and-feasibility-studies","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"pafs","sideBox":"Learn more about [Pilot and Feasibility Studies](http://pilotfeasibilitystudies.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/PAFS/default.aspx","title":"Pilot and Feasibility Studies","twitterHandle":"@MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Type 2 diabetes prevention, Lifestyle modification, Randomised control trial, Recruitment strategies, Targeted promotion, General Practice referral, Barriers and enablers.","lastPublishedDoi":"10.21203/rs.3.rs-6482322/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-6482322/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e \u003cp\u003eGovernments worldwide consider randomised controlled trials (RCTs) as the accepted gold standard design to evaluate healthcare interventions. However, enrolling participants into RCTs can be challenging, with recruitment processes serving as a crucial determinant of any clinical trial or program\u0026rsquo;s success. This study aimed to characterise the relative effectiveness and cost of different strategies used to recruit individuals into a randomised control trial of an Australian Lifestyle Change Program (AUS2PREVENT) to prevent or delay type 2 diabetes in South Australia.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eTargeted recruitment over a 12-month period through General Practitioner (GP) clinics was the primary strategy used to recruit individuals at risk of, or with prediabetes. After protocol amendments, around 25,000 individuals were identified as having prediabetes and being potentially eligible for the trial from 279 GP clinics across metropolitan Adelaide. Additional channels used to recruit self-referring, high risk individuals, included radio, online media (e.g., Facebook, Instagram, webpages), email distribution lists, and member-orientated magazines/ newsletters associated with the supporting health and community organisations.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eOf the 1,393 expressions of interest, 587 individuals completed the pre-screening survey and reported the referral channel. Radio, email and online media generated the greatest number of individuals expressing interest in the trial (284 vs 151 vs 91, respectively) and accounted for the final 67 individuals who were enrolled and randomised. Promotion through GP clinics, radio, and online media were the costliest strategies; only 4 individuals reported being referred by their GP.\u003c/p\u003e\u003ch2\u003eConclusions\u003c/h2\u003e \u003cp\u003eTimely and cost-effective recruitment of people into a preventive health program requires a recruitment strategy that is adaptive, multi-channelled, location-specific and appropriate for the population being targeted and the trial design being used. To optimise engagement in such programs, further research is warranted to explore the experiences and perspectives of individuals participating in preventive health interventions. Additionally, gaining deeper insights into the views of GPs, clinic managers, and other staff within the Primary Health Network is vital to understanding their role in referring high-risk individuals to trials evaluating prevention programs.\u003c/p\u003e\u003ch2\u003eTrial Registration:\u003c/h2\u003e \u003cp\u003eThe trial is registered on the Australian New Zealand Clinical Trials Registry (ANZCTR), Universal Trial Number U1111-1220-5636.\u003c/p\u003e","manuscriptTitle":"Recruitment of individuals into a type 2 diabetes prevention program: key barriers and enablers identified from the randomised control trial testing an Australian Lifestyle Change Program (AUS2PREVENT)","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-05-28 08:37:41","doi":"10.21203/rs.3.rs-6482322/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"reviewersInvited","content":"","date":"2025-05-21T15:22:52+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-04-22T05:38:00+00:00","index":"","fulltext":""},{"type":"submitted","content":"Pilot and Feasibility Studies","date":"2025-04-19T00:28:31+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"pilot-and-feasibility-studies","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"pafs","sideBox":"Learn more about [Pilot and Feasibility Studies](http://pilotfeasibilitystudies.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/PAFS/default.aspx","title":"Pilot and Feasibility Studies","twitterHandle":"@MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"89e67bcc-51e5-4d08-9c2a-7149bed0e570","owner":[],"postedDate":"May 28th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2026-01-19T17:05:42+00:00","versionOfRecord":{"articleIdentity":"rs-6482322","link":"https://doi.org/10.1186/s40814-025-01759-6","journal":{"identity":"pilot-and-feasibility-studies","isVorOnly":false,"title":"Pilot and Feasibility Studies"},"publishedOn":"2026-01-17 16:30:03","publishedOnDateReadable":"January 17th, 2026"},"versionCreatedAt":"2025-05-28 08:37:41","video":"","vorDoi":"10.1186/s40814-025-01759-6","vorDoiUrl":"https://doi.org/10.1186/s40814-025-01759-6","workflowStages":[]},"version":"v1","identity":"rs-6482322","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-6482322","identity":"rs-6482322","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}