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
Full Title of Study: “Value and Mechanisms of Home Visitation in Obesity Interventions for Low-income Children”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Double (Investigator, Outcomes Assessor)
- Study Primary Completion Date: May 2021
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 6-11 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.
- Behavioral: Family-based pediatric obesity treatment
- Families with at least one overweight/obese child between ages 6 and 11 years will receive 12-months of family-based pediatric obesity treatment that emphasizes healthy changes to the home environment and family routines. The intervention targets dietary intake, physical activity, and consistent sleep.
Arms, Groups and Cohorts
- Active Comparator: Medical center treatment arm
- Family-based pediatric obesity treatment delivered at an urban medical center.
- Experimental: Home treatment arm
- Family-based pediatric obesity treatment delivered in the family’s home.
Clinical Trial Outcome Measures
- Child adiposity
- Time Frame: 12 months
- Change from baseline in child body mass index z-score (zBMI)
- Clinically significant weight loss
- Time Frame: 12 months
- Proportion of children achieving adiposity reduction of at least 0.25 zBMI
- Time Frame: 12 months
- Incremental cost-effectiveness ratio of home-based vs medical center treatment, calculated from societal perspective.
Participating in This Clinical Trial
- Family includes at least one child who is 6 to 11 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 ≤ 1.85 Exclusion Criteria:
- 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
Gender Eligibility: All
Minimum Age: 6 Years
Maximum Age: 11 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Rush University Medical Center
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Provider of Information About this Clinical Study
- Overall Contact(s)
- Bradley M Appelhans, PhD, 312-942-3477, email@example.com
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