A Trial of an Integrated Clinic-community Intervention in Children and Adolescents With Obesity (Hearts and Parks)
- Conditions
- Childhood ObesityPediatric ObesityCardiovascular Risk FactorQuality of Life
- Interventions
- Behavioral: Hearts & Parks
- Registration Number
- NCT03339440
- Lead Sponsor
- Duke University
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 327
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Intervention Group Hearts & Parks Patients in this group will be receiving the Hearts and Parks intervention.
- Primary Outcome Measures
Name Time Method Number of subjects enrolled versus number of subjects who meet min. participation criteria 12 months As measured by enrollment logs
Change in z-BMI Baseline, 6 months Change in molecular pathways dysregulated in pediatric obesity Baseline, 6 months Stool and blood samples
Physical activity Up to 12 months child physical activity; objectively tracked with fitness tracker
Change in child fitness baseline, 3 months, 12 months 3 minute bench stepping test
Change in Child Quality of Life baseline, 3 months, 12 months Composite score of Sizing Me Up Questionnaires
Change in Body Appreciation baseline, 3 months, 12 months Body appreciation scale 13-item questionnaire (1. Never, 2. Seldom, 3. Sometimes, 4. Often, 5. Always)
Change in heart rate baseline, 12 months Change in FLASHE Food and Activity Screener Scores Baseline, 6 months, 12 months Questionnaire about child and parent nutrition and activity habits
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) baseline, 3 months, 12 months PROMIS Questionnaire (not composite score)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- 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