A Trial of an Integrated Clinic-community Intervention in Children and Adolescents With Obesity (Hearts and Parks)
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Child age 5-18 years
- Child body mass index ≥ 95th %ile
- Parent can speak and read in English or Spanish
- Parent ownership of a device that is able to receive and send text messages
Exclusion criteria
- Live farther than a 20-mile radius from the Healthy and Fit program site
- Endogenous or genetic cause of obesity
- Taking a medication that causes weight gain
- Participation in a pediatric weight management program within 12 months
- Parent or child significant health problem that would limit participation
- Enrollment is above the max weekly enrollment of 60 participants/week)
- Reported or planned pregnancy
Opt-out Criteria
• Primary care physician opts patient out of study for reasons including: severe obesity, urgent co-morbidities, parental unwillingness to be contacted by a research assistant, or at physician clinical judgment.
Trial design
Primary purpose
Allocation
Interventional model
Masking
327 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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