Family Focused Community Program to Prevent Type 2 Diabetes in Peripubertal Youth
Condition: Pediatric Obesity
MeSH terms: Pediatric Obesity
Study type: Interventional

Summary: 
      Over one-third of children and adolescents are overweight and nearly 1 in 5 of them are
      obese. Metabolic syndrome, a strong predictor of Type 2 diabetes (T2D) and cardiovascular
      disease (CVD), occurs in up to 44% of obese youth, foreshadowing greater prevalence and
      earlier onset of T2D. Without effective interventions, "diabesity" will worsen, T2D
      prevalence will increase, and adults will face its consequences at younger ages. Given the
      strong association between obesity and chronic disease risk factors in youth, the
      investigators contend T2D prevention (and CVD prevention) is akin to weight control and
      obesity prevention. The objective of the proposed project is to develop a family-centered,
      community-based program for T2D prevention in peripubertal (9- to 12-year-old) youth. Using
      participatory methods, the investigators intend to adapt the successful adult-focused YMCA
      Diabetes Prevention Program (YDPP) for youth and families and assess the feasibility,
      participant acceptance of and adherence to the YFDPP using two delivery formats: a 12-week
      YMCA-based face-to-face program and a 12-week combined face-to-face plus mobile device-based
      program. The proposed study will test the investigators premise that delivery with technology
      can reduce participant perceived burden, improve adherence, and lead to improved
      anthropometric (height, weight and BMI and waist circumference), behavioral (diet and
      physical activity) and physiological outcomes (fasting insulin, glucose, lipid, blood
      pressure). The investigators will use the resulting data to design an appropriately powered
      full-scale trial. The importance of the proposed study is underscored both by the statistics
      cited above and the recent call for proposals to translate efficacious clinical interventions
      into effective community programs for youth. The potential impact of the proposed
      intervention is great in that the program will be delivered by paraprofessionals from the
      community without university researchers; significant in that it targets a major public
      health challenge in children and includes assessment of objective behavioral and clinical
      data; and innovative in that it focuses on an at-risk population, takes place at a popular,
      accessible community venue, and uses mobile technologies to extend reach and increase
      engagement of youth and families with intervention content. The long-term goal is to create a
      scalable, replicable, and sustainable program that overcomes existing barriers to
      implementation and dissemination of evidence-based, research-proven diabetes prevention
      programs to youth and families, thereby improving population health.
    

Detailed description: 
      The investigators objective is to develop a family-centered, community-based program for T2D
      prevention in peripubertal (9-12-year-old) youth. Efficacious community programs for youth
      are not available (although promising components exist), and thus the investigators propose
      to adapt the successful adult-focused YMCA Diabetes Prevention Program (YDPP) for youth and
      families, and assess its impact on anthropometric, behavioral and physiological outcomes in
      support of the design (power calculation) of a full-scale trial. The proposed study will
      evaluate the adapted program using two formats (with and without mobile technologies).
      Secondary endpoints will include participant perceived burden, adherence, and program costs.

      Aim 1: Adapt an efficacious diabetes prevention program in adults (the YMCA Diabetes
      Prevention Program, or YDPP) for delivery to overweight peripubertal youth and their
      families, thereby establishing a YMCA Family Diabetes Prevention Program (YFDPP).

      Aim 2: Test the feasibility, participant acceptance (child and parent) and retention rates of
      the YFDPP using two formats, a 12-week YMCA-based face-to-face program and a 12-week program
      with content delivered through a combination of face-to-face and mobile devices.

      Aim 3: Test the impact of the new YFDPP using two formats on anthropometric (height, weight,
      BMI and waist circumference), behavioral (diet and physical activity), and physiological
      (fasting insulin, glucose, lipid) outcomes, using the resulting data to design an
      appropriately powered full-scale trial.
    

Intervention name(s): YMCA Family Diabetes Prevention Program (YFDPP)
Intervention type(s): Behavioral
Intervention description(s): 12 week, group education to promote behavioral change delivered either face-to-face or via a combination of face-to-face and mobile technologies
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Intervention Studies