Family Weight Management Study
Condition: Obesity; Diabetes
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to address the Healthy People 2010 obesity prevention objective.
      This study will test the effects of a comprehensive family weight management program on the
      BMI z-score of 7-12 year-old children with a BMI > 85th percentile who receive primary care
      in a large municipal Bronx hospital. The intervention framework will draw on social marketing
      theory and the transtheoretical model of behavioral change to incorporate successful obesity
      prevention strategies. A two-arm randomized controlled clinical trial (RCT), which will
      enroll (n =506) 7-12 year old children with a > 85th BMI percentile, will compare the
      Experimental Intensive Intervention to a Standard (Control) Intervention. The Standard
      Intervention will receive: 1) an initial consult, which includes an overview of lifestyle
      goals, 2)quarterly follow-up, 3) and a monthly newsletter. The Intensive Intervention will
      add: 1)12 core group modules for parents (to address roles and skills) and for children (to
      enhance motivation and skills and to provide physical activity), 3) Tailored support using a
      "toolbox" approach from community health workers as extensions of the Family Weight
      Management professional education staff, and 4) monthly after-core follow-up groups. The
      study will determine if children randomized to the Experimental Intensive Intervention will
      have greater improvement in BMI change (z-scores) than those randomized to the Control
      Standard Intervention. The study will also evaluate the effects on the Experimental
      Intervention on lifestyle variables and assess intervention costs. The RE-AIM evaluation will
      address: Reach: How many of the eligible children/ families were referred and how many of
      those referred actually enrolled? We will use BMI data in the computerized medical records to
      evaluate the proportion and the appropriateness of the referrals. Efficacy/Effectiveness: How
      did the Experimental intervention affect BMI (changes in z-score), and key biomarkers when
      followed as planned? Adoption: How acceptable were the intervention(s) to the primary care
      medical team and the children/families in the pediatric clinics etc? (from process measures
      and post intervention surveys) Implementation: How many of the intervention activities were
      provided as planned? Quality control measures will be used to evaluate the integrity of the
      intervention(s). Maintenance: How much of the intervention effect is sustainable? Individual
      effects will be evaluated based on the 24 month follow data. Institutional effects evaluation
      will include the potential to maintain services using third-party coverage.
    


Intervention name(s): Intensive lifestyle; Standard intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The intensive lifestyle intervention will include the standard intervention plus 1)12 core group modules for parents (to address roles and skills) and for children (to enhance motivation and skills and to provide physical activity), 3) Tailored support using a "toolbox" approach from community health workers as extensions of the Family Weight Management professional education staff, and 4) monthly after-core follow-up groups.; The Standard Intervention will receive: 1) an initial consult, which includes an overview of lifestyle goals, 2) quarterly follow-up, 3) and a monthly newsletter.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: children; obesity; weight loss; prevention; diabetes risk; cardiometabolic