Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Childhood Obesity
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Randomized controlled trialMasking: Double (Investigator, Outcomes Assessor)Masking Description: Outcomes assessors, PI, and some co-investigators will be blinded to group assignment.Primary Purpose: Treatment

Participation Requirements

Age
Between 6 years and 11 years
Gender
Both males and females

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...

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.

Tracking Information

NCT #
NCT03195790
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Not Provided