NCT03339440

A Trial of an Integrated Clinic-community Intervention in Children and Adolescents With Obesity (Hearts and Parks)

A Randomized Trial of an Integrated Clinic-community Intervention in Children and Adolescents With Obesity

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 327 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 5 Years – 18 Years
• Healthy volunteers: Accepted

Summary

The investigators propose a randomized controlled effectiveness trial to evaluate the integrated clinic-community model of child obesity treatment as compared with routine primary care.

Detailed description

The purpose of this study is to evaluate how different types of physical activity and nutrition education and support (in addition to normal clinical care) affect children's health. The investigators will be looking at changes in child BMI, physical activity, nutrition, and overall health. The investigators also hope to better understand biological differences in metabolism and the microbiome (the bacteria that grows normally on and in the body) in children with high BMI who are making lifestyle changes.

Conditions

• Childhood Obesity
• Pediatric Obesity
• Quality of Life
• Cardiovascular Risk Factor

Interventions

Type	Name	Description
BEHAVIORAL	Hearts & Parks	The Hearts \& Parks intervention will be looking to evaluate how different types of physical activity and nutrition education and support (in addition to normal clinical care) through attendance and participation in the Duke Healthy Lifestyles/Bull City Fit clinic/community program, affect children's health. The investigators will be looking at changes in BMI, physical activity, nutrition and overall health.

Timeline

• Start date: 2018-01-10
• Primary completion: 2021-06-30
• Completion: 2021-06-30
• First posted: 2017-11-13
• Last updated: 2021-11-04

Locations

3 sites across 1 country: United States