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

Duke University327 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

327

Conditions

Childhood Obesity Pediatric Obesity Quality of Life Cardiovascular Risk Factor

Interventions

Hearts & ParksBEHAVIORAL

The Hearts \& Parks intervention will be looking to evaluate how different types of physical activity and nutrition education and support (in addition to normal clinical care) through attendance and participation in the Duke Healthy Lifestyles/Bull City Fit clinic/community program, affect children's health. The investigators will be looking at changes in BMI, physical activity, nutrition and overall health.

Eligibility

Sex: ALLMin age: 5 YearsMax age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (3)

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

Outcomes

Primary Outcomes

Change in z-BMI

Time frame: Baseline, 6 months

Change in heart rate

Time frame: baseline, 12 months

Number of subjects enrolled versus number of subjects who meet min. participation criteria

As measured by enrollment logs

Time frame: 12 months

Change in molecular pathways dysregulated in pediatric obesity

Stool and blood samples

Time frame: Baseline, 6 months

Physical activity

child physical activity; objectively tracked with fitness tracker

Time frame: Up to 12 months

Change in child fitness

3 minute bench stepping test

Time frame: baseline, 3 months, 12 months

Change in Child Quality of Life

Composite score of Sizing Me Up Questionnaires

Time frame: baseline, 3 months, 12 months

Change in Body Appreciation

Body appreciation scale 13-item questionnaire (1. Never, 2. Seldom, 3. Sometimes, 4. Often, 5. Always)

Time frame: baseline, 3 months, 12 months

Change in FLASHE Food and Activity Screener Scores

Questionnaire about child and parent nutrition and activity habits

Time frame: Baseline, 6 months, 12 months

Change in fasting lipid profile

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.