The authors declare that they have no competing interests.
MH and SBG conceived of the study; MH, SBG, CS, and DR participated in its design; MH and TT contributed to curriculum development; MH, RK, NM and TT participated in the coordination of implementing the intervention; MH was responsible for overall project management; and MH and TT helped to draft the manuscript. MH and TT created the measurement and process evaluation protocols, and participated in data collection. All authors read and approved the final manuscript.
MH (PhD, MPH, RD) is an Assistant Professor in the Department of Nutritional Sciences and project PI; TT (PhD) is a Postdoctoral Research Associate in the Nutritional Sciences Department; RK (MD, MPH) is an Associate Professor of Family and Community Medicine; NV (MS) is Director of Biotechnology and Computing at Arizona Research Laboratories; DR (DrPH) is Professor and Program Director of Biostatistics at the Mel and Enid Zuckerman College of Public Health; CS (MD, PhD) is Associate Professor of Medicine and Endocrinology Division Chief at the Department of Medicine; SBG (PhD) is Professor and Department Head of the Department of Nutritional Sciences.
It is well established that behavioral lifestyle interventions resulting in modest weight reduction in adults can prevent or delay type 2 diabetes mellitus; however in children, successful weight management interventions are rarely found outside of controlled clinical settings. The lack of effective community-based programs is a barrier to reducing obesity prevalence and diabetes risk in children. The objective of our study is to develop and test a group-randomized family-centered community-based type 2 diabetes prevention intervention targeting at-risk children, 9- to 12-years-old.
Using participatory methods, the adult-focused YMCA Diabetes Prevention Program was adapted for families, creating a novel lifestyle behavior change program focused on healthy eating, physical activity, and a supportive home environment. The program will be tested in sixty 9- to 12-year-old children at risk of diabetes and sixty parents over 12 consecutive weeks with two intervention formats randomized by location: a face-to-face instructor-led program, or a hybrid program with alternating face-to-face and mobile technology-delivered content. Anthropometric, behavioral, psychosocial and physiological outcomes will be assessed at baseline, post-intervention (12 weeks), and follow-up (24 weeks). Secondary outcomes are participant acceptability, feasibility, and adherence. The RE-AIM framework (reach, efficacy, adoption, implementation, and maintenance) will guide intervention implementation and evaluation. Changes at 12 weeks will be assessed using a paired t-test combining both delivery formats. Exploratory models using linear regression analysis will estimate the magnitude of the difference between the face-to-face and hybrid format. The sample size of 60 children, informed by a previous YMCA intervention in which −4.3 % change in overweight (SE = 1.1) was observed over 6 months, will give us 80 % power to detect an effect size of this magnitude, assuming a one-sided test at alpha = 0.05.
The proposed study capitalizes on a partnership with the YMCA, a popular and widespread community organization, and uses mobile technologies to extend program reach while potentially reducing burden associated with weekly attendance. The long-term goal is to create a scalable, replicable, and sustainable pediatric “diabesity” prevention program that overcomes existing barriers to the translation of efficacious interventions into effective community programs.
ClinicalTrials.gov, NCT02421198 on April 15, 2015