Clinical Trials Directory

Trials / Completed

CompletedNCT03195790

Creating Healthy Environments for Chicago Kids

Value and Mechanisms of Home Visitation in Obesity Interventions for Low-income Children

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
269 (actual)
Sponsor
Rush University Medical Center · Academic / Other
Sex
All
Age
6 Years – 12 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALFamily-based pediatric obesity treatmentFamilies 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.

Timeline

Start date
2017-08-08
Primary completion
2022-09-19
Completion
2022-09-19
First posted
2017-06-22
Last updated
2024-11-04

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03195790. Inclusion in this directory is not an endorsement.