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

Completed · Not applicable

Conditions studied: Childhood Obesity, Pediatric Obesity, Quality of Life, Cardiovascular Risk Factor

In brief

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.

Key facts

Study ID

NCT03339440

Run by

Duke University

People needed

327

Starts

2018-01-10

Expected to finish

2021-06-30

Last updated by the study team

2021-11-04

Who can join

Age: 5 and older, up to 18. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Duke Children's Primary Care Roxboro Street — Durham, North Carolina, United States
• Durham Pediatrics at North Duke Street — Durham, North Carolina, United States
• Regional Pediatrics - North Durham — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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