A Primary Care Behavioral Approach for Addressing Childhood Overweight
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether participation in a group-based health
      education curriculum is superior to receipt of standardized health educational materials for
      children who are overweight or at risk for overweight with regard to achievement of a
      healthier body weight and improvement of key eating and physical activity behaviors.
    

Detailed description: 
      In the United States, childhood obesity has tripled since 1970 such that 15% of those 6 to 19
      years of age are obese, with higher observed prevalences for African-American and Hispanic
      children. Childhood obesity has significant short- and long-term health consequences. To
      avoid future morbidity, children who are obese or at risk for obesity must be identified and
      treated at an early stage. The primary care setting, where most children receive health care
      and where BMI should be tracked, may represent an early opportunity for identifying and
      treating childhood obesity. However, translational research is needed to test whether
      existing strategies for childhood obesity can be adapted for delivery via the primary care
      setting

      The ultimate purpose of this work is to help overweight children, particularly those who are
      African-American, optimize their lifespan and quality of health through achievement of a
      healthier body mass index (BMI). Specific aims are to perform outcome and process evaluations
      to determine whether the intervention results in improvement in BMI percentile or habitual
      healthy eating and physical activity behaviors, and whether the intervention is feasible. The
      outcome evaluation component involves a randomized controlled trial, in which overweight
      children (BMI for age percentile >=95th) and children at risk for overweight (BMI for age
      percentile 85-94th)together with a parent/caregiver receive the primary care-based
      intervention or health education materials only. The intervention will focus on four main
      behavioral changes: decreasing consumption of key calorie-dense foods, increasing consumption
      of fruits and vegetables to ≥ 5 a day, reducing targeted sedentary behaviors to < 15 hrs per
      week, and increasing moderate and vigorous physical activity to 60 minutes or more daily. We
      will assess change in BMI percentile, number of servings of calorie-dense foods daily, and
      percent of time spent in sedentary and physical activities at 6-, 12-, and 18-months using
      mixed-model ANCOVA for repeated measures.
    

Intervention name(s): Group-based behavioral intervention
Intervention type(s): Behavioral
Intervention description(s): The group-based behavioral intervention targets eating behaviors, physical activity, and "screen time", and is delivered to participating children and their parent/caregiver over the course of 4 weeks. Maintenance sessions occur every 3 months thereafter.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Behavioral/Social; Obesity; Pediatrics; Preventive Medicine