title: The EPIC Kids Study: a randomized family-focused YMCA-based intervention to prevent type 2 diabetes in at-risk youth.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov, NCT02421198 on April 15, 2015.
authors.affiliation: Department of Nutritional Sciences, The University of Arizona, 1177 E 4th St, Shantz Bldg, Room 328, Tucson, AZ, 85721, USA. hinglem@email.arizona.edu.
authors.forename: Melanie D
authors.initials: MD
authors.lastname: Hingle
authors.affiliation: Department of Nutritional Sciences, The University of Arizona, 1177 E 4th St, Shantz Bldg, Room 328, Tucson, AZ, 85721, USA. tamiturner@email.arizona.edu.
authors.forename: Tami
authors.initials: T
authors.lastname: Turner
authors.affiliation: Department of Family & Community Medicine, The University of Arizona, Faculty Office Building #220, Tucson, AZ, USA. rkutob@email.arizona.edu.
authors.forename: Randa
authors.initials: R
authors.lastname: Kutob
authors.affiliation: Arizona Research Laboratories, The University of Arizona, TW Keating Bioresearch Bldg. #240, Tucson, AZ, USA. nirav@email.arizona.edu.
authors.forename: Nirav
authors.initials: N
authors.lastname: Merchant
authors.affiliation: Mel & Enid Zuckerman College of Public Health, The University of Arizona, Leon Levy Cancer Center #222, Tucson, AZ, USA. droe@email.arizona.edu.
authors.forename: Denise J
authors.initials: DJ
authors.lastname: Roe
authors.affiliation: Department of Medicine, The University of Arizona, AHSC #05099, Tucson, AZ, USA. stumpc@email.arizona.edu.|Southern Arizona VA Health Care System, Tucson, AZ, USA. stumpc@email.arizona.edu.
authors.forename: Craig
authors.initials: C
authors.lastname: Stump
authors.affiliation: Department of Nutritional Sciences, The University of Arizona, 1177 E 4th St, Shantz Bldg, Room 328, Tucson, AZ, 85721, USA. going@email.arizona.edu.
authors.forename: Scott B
authors.initials: SB
authors.lastname: Going
mesh_terms: D001521:Behavior Therapy; D002648:Child; D003924:Diabetes Mellitus, Type 2 / Q000517:prevention & control*; D005190:Family; D005260:Female; D006293:Health Promotion / Q000458:organization & administration*; D006801:Humans; D008019:Life Style; D008297:Male; D009765:Obesity / Q000517:prevention & control; D050177:Overweight; D015397:Program Evaluation; D012107:Research Design; D012111:Residence Characteristics; D012307:Risk Factors