A Trial of an Integrated Clinic-community Intervention in Children and Adolescents With Obesity (Hearts and Parks)
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 350
Summary
- Conditions
- Cardiovascular Risk Factor
- Childhood Obesity
- Pediatric Obesity
- Quality of Life
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: The investigators will use a two-arm, randomized crossover controlled trial to compare routine primary care management of childhood obesity versus a novel clinic/family/community partnership program to treat childhood obesity. This design will allow for a randomized comparison of Group 1 (6-month standard control) to Group 2 (immediate 6-month intervention program) and to Group 3 (delayed crossover intervention on the standard control group). The design will also allow the investigators to observe intervention effects at 3 months in both intervention groups (Groups 2 and 3), and to track Group 2 for 6 additional months after active intervention to assess whether health benefits seen at 6 months were sustained to 12 months.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 5 years and 18 years
- Gender
- Both males and females
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 inves...
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.
Tracking Information
- NCT #
- NCT03339440
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Sarah Armstrong, MD Duke University
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