Creating Healthy Environments for Chicago Kids
- Conditions
- Childhood Obesity
- Interventions
- Behavioral: Family-based pediatric obesity treatment
- Registration Number
- NCT03195790
- Lead Sponsor
- Rush University Medical Center
- Brief Summary
Pediatric obesity interventions for low-income populations are increasingly delivered in children's homes, which may make treatment more accessible to families and enhance the potency of the intervention in several ways. This randomized trial will directly test whether delivering family-based behavioral interventions for pediatric overweight/obesity in the home setting improves weight loss outcomes in low-income children relative to medical center-based treatment. The trial will also quantify the cost-effectiveness of home visitation, and explore the mechanisms accounting for observed treatment effects
- Detailed Description
The goal of this project is to systematically evaluate the incremental weight loss benefit and cost-effectiveness of delivering standard family-based treatment for pediatric overweight/obesity in the home setting vs. traditional medical settings. In a randomized controlled trial involving low-income households, 266 children ages 6-12 years will be allocated to 12 months of family-based treatment delivered either in their home or at an urban academic medical center. Both arms will receive the same intervention content and dosage, and differ only in the location of in-person treatment sessions. Aim 1 is to test the hypothesis that home-based treatment produces a greater reduction in child adiposity, reflected in 12-month change in BMI z-score. Aim 2 is to compare the cost-effectiveness of home-based treatment to medical center-based treatment, and calculate the added cost of the incremental weight loss benefit associated with home visitation. These data will inform efforts to disseminate home-based interventions for low-income populations by public health agencies and third-party payers. Aim 3 is to explore specific mechanisms through which home visitation may improve weight loss outcomes.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 269
- Family includes at least one child who is 6 to 12 years old, and is overweight or obese (has a body mass index at or above the 85th percentile for age and sex)
- Child's household has an income-to-poverty ratio ≤ 2.0
- Child or caregiver(s) are not fluent in English
- Unwilling to attend and complete either home-based or clinic-based treatment, or to complete any aspect of the study assessment battery
- Medical contraindication or barrier to weight loss treatment
- Caregiver has a major medical or psychiatric condition likely to interfere with treatment
- Plans to relocate outside the Chicago area in the next 12 months, or living in temporary or group housing with other families
- Resides more than 15 miles from the Illinois Medical District (study site)
- Conditions in or around the home that jeopardize staff/interventionist safety
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Medical center treatment arm Family-based pediatric obesity treatment Family-based pediatric obesity treatment delivered at an urban medical center. Home treatment arm Family-based pediatric obesity treatment Family-based pediatric obesity treatment delivered in the family's home.
- Primary Outcome Measures
Name Time Method Child adiposity 12 months Change from baseline in child body mass index z-score (zBMI)
- Secondary Outcome Measures
Name Time Method Clinically significant weight loss 12 months Proportion of children achieving adiposity reduction of at least 0.25 zBMI
Cost-effectiveness 12 months Incremental cost-effectiveness ratio of home-based vs medical center treatment, calculated from societal perspective.
Trial Locations
- Locations (1)
Rush University Medical Center
🇺🇸Chicago, Illinois, United States