Status:
COMPLETED
A Trial of an Integrated Clinic-community Intervention in Children and Adolescents With Obesity (Hearts and Parks)
Lead Sponsor:
Duke University
Conditions:
Childhood Obesity
Pediatric Obesity
Eligibility:
All Genders
5-18 years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2021
Estimated Enrollment :
327 Patients enrolled
Trial Details
Trial ID
NCT03339440
Start Date
January 10 2018
End Date
June 30 2021
Last Update
November 4 2021
Active Locations (3)
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1
Duke Children's Primary Care Roxboro Street
Durham, North Carolina, United States, 27704
2
Durham Pediatrics at North Duke Street
Durham, North Carolina, United States, 27704
3
Regional Pediatrics - North Durham
Durham, North Carolina, United States, 27704