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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Behavioral: Hearts & Parks


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: The investigators will use a two-arm, randomized crossover controlled trial to compare routine primary care management of childhood obesity versus a novel clinic/family/community partnership program to treat childhood obesity. This design will allow for a randomized comparison of Group 1 (6-month standard control) to Group 2 (immediate 6-month intervention program) and to Group 3 (delayed crossover intervention on the standard control group). The design will also allow the investigators to observe intervention effects at 3 months in both intervention groups (Groups 2 and 3), and to track Group 2 for 6 additional months after active intervention to assess whether health benefits seen at 6 months were sustained to 12 months.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Patients in this group will be receiving the Hearts and Parks intervention. | Behavioral: Hearts & Parks<br>* 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.<br>|
| No Intervention: Control Group<br>Patients in this group will continue receiving standard of care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in z-BMI |  | Baseline, 6 months | 
| Change in heart rate |  | baseline, 12 months | 
| Number of subjects enrolled versus number of subjects who meet min. participation criteria | As measured by enrollment logs | 12 months | 
| Change in molecular pathways dysregulated in pediatric obesity | Stool and blood samples | Baseline, 6 months | 
| Physical activity | child physical activity; objectively tracked with fitness tracker | Up to 12 months | 
| Change in child fitness | 3 minute bench stepping test | baseline, 3 months, 12 months | 
| Change in Child Quality of Life | Composite score of Sizing Me Up Questionnaires | 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) | baseline, 3 months, 12 months | 
| Change in FLASHE Food and Activity Screener Scores | Questionnaire about child and parent nutrition and activity habits | Baseline, 6 months, 12 months | 
| Change in fasting lipid profile |  | Baseline, 6 months, 12 months | 
| Change in fasting glucose |  | Baseline, 6 months, 12 months | 
| Change in alanine aminotransferase (A1) |  | Baseline, 6 months, 12 months | 
| Change in child quality of life (2) | PROMIS Questionnaire (not composite score) | baseline, 3 months, 12 months |