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



Status:Recruiting
Conditions:Obesity Weight Loss, Peripheral Vascular Disease
Therapuetic Areas:Cardiology / Vascular Diseases, Endocrinology
Healthy:No
Age Range:5 - 18
Updated:4/17/2018
Start Date:January 10, 2018
End Date:December 2021
Contact:Sophie Ravanbakht
Email:sophie.ravanbakht@duke.edu
Phone:919-620-4732

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

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.

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.

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.
We found this trial at
3
sites
Durham, North Carolina 27704
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Durham, NC
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Durham, North Carolina 27704
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from
Durham, NC
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Durham, North Carolina 27704
?
mi
from
Durham, NC
Click here to add this to my saved trials