Texas Childhood Obesity Research Demonstration (TX CORD) Project
Condition: Childhood Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      A systems approach emphasizes the linkage between individual behavior change strategies and
      social and physical environmental changes, which act synergistically to facilitate (or
      inhibit) healthy eating and active living. The hypothesis of this study is that among
      low-income, ethnically diverse overweight and obese children, aged 2-12 years, a systems
      approach to child obesity will reduce body mass index (BMI) compared to primary prevention
      alone.
    

Detailed description: 
      The goal of this project is to develop, implement and evaluate an integrated,
      systems-oriented obesity model for underserved, ethnically diverse children aged 2-12 years.
      The first step will include conducting an assets-based community assessment in low-income
      neighborhood catchment areas in Austin and Houston, TX with input and data-sharing from
      existing partnerships. Results from this assessment will inform and facilitate the
      implementation of both primary and secondary prevention efforts across multiple sectors
      (healthcare, school, and childcare). The demonstration project will include secondary
      prevention programs embedded within community primary prevention efforts. For primary
      prevention, a quasi-experimental approach will be used, where existing obesity prevention
      efforts are reinforced and optimized in healthcare clinics, Head Start Centers and schools in
      the catchment areas (NOTE: the primary prevention intervention study is further described in
      ClinicalTrials.gov at Texas Childhood Obesity Research Demonstration project Primary
      Prevention Intervention {TXCORDPRIM) under a different protocol & record). Secondary
      prevention includes integration of the investigative team's evidence-based portfolio of
      family and community interventions, specifically the MEND/CATCH programs. For secondary
      prevention, a randomized controlled trial design will be used in which individual
      overweight/obese children are randomized to a 12-month community-centered, family-based
      obesity program or to primary prevention alone.

      The hypothesis of this study is that among low-income, ethnically diverse overweight and
      obese children, aged 2-12 years, a systems approach to child obesity will reduce body mass
      index (BMI, expressed as %95th percentile) compared to primary prevention alone. The specific
      aims of the grant are as follows (see below).

      Aim 1: To implement and evaluate the efficacy of a systems approach to child obesity on
      reducing BMI (expressed as %95th percentile) by embedding a 12-month family-based secondary
      prevention program within a community primary prevention program. The secondary prevention
      weight management program will target overweight/obese children and their families in the
      primary prevention catchment areas in Austin and Houston. Overweight/obese children (total
      n=576), aged 2-12 years, will be randomly assigned to either the 12-month secondary
      prevention program (experimental) or the community primary prevention program alone
      (control), in equal age subgroups (2-5, 6-8, and 9-12 years). Analyses will be conducted by
      age group, and outcomes will include BMI as expressed as %95th percentile), obesity-related
      behaviors, quality of life, and program use indicators.

      Aim 2: To quantify the incremental cost-effectiveness of the 12-month family-based secondary
      prevention program relative to primary prevention alone for child obesity. Activity Based
      Costing methods will be used to quantify the incremental cost of delivering the secondary
      prevention program relative to optimized healthcare. These costs will then be combined with
      the effectiveness data to quantify the incremental cost-effectiveness of the community-based
      intervention.

      All project activities will be coordinated with input from Demonstration Project Research
      Network Committee (CDC and the Evaluation Center).
    

Intervention name(s): BMI screening; Next Steps brief clinical intervention; MEND/CATCH; MEND/CATCH Transition Phase; Next Steps Self-Paced Booklet
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Physician screening of patients to identify patients who are overweight or obese.; This intervention included identification of children who were overweight or obese, and Next Steps brief counseling materials for the healthcare provider (prior to enrollment in the intervention).; MEND 2-5 and MEND/CATCH 6-12 programs are multi-component interventions including behavioral, nutrition, and physical activity sessions. In the intensive (first 3 months) phase, MEND 2-5 entailed nine weekly sessions and MEND 6-12 entailed 18 twice weekly sessions.; The transition phase (next 9 months of the 12-month program) included monthly 90-minute sessions for parents and children included MEND reviews, cooking classes, Being Well book, CATCH activities and MEND World activities. Children were enrolled in YMCA sports teams or programs offered twice weekly to encourage physical activity. Weekly text messages were sent to parents to reinforce behavioral objectives of the intervention.; Next Steps booklet for parents and children to work on nutrition and physical activity targets in a self-directed manner. Families were encouraged to seek repeated clinical visits to address child obesity as a follow up to the self-paced booklet.
Other intervention name(s): Body Mass Index (BMI) Screening; Next Steps; Mind Exercise Nutrition Do it! (MEND); Coordinated Approach To Child Health (CATCH); Next Steps Workbook
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: child obesity; primary prevention; primary care; weight management; child overweight; BMI