An interventional study of Hearts & Parks in Childhood Obesity, Pediatric Obesity and Quality of Life, sponsored by Duke University. Completed at 3 sites in United States. Open to participants aged 5 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-04.
Sponsored by Duke University · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
Opt-out Criteria
Patients in this group will be receiving the Hearts and Parks intervention.
Behavioral: Hearts & Parks
Patients in this group will continue receiving standard of care.
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.
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
Time frame: Baseline, 6 months, 12 months
Change in fasting glucose
Time frame: Baseline, 6 months, 12 months
Change in alanine aminotransferase (A1)
Time frame: Baseline, 6 months, 12 months
Change in child quality of life (2)
PROMIS Questionnaire (not composite score)
Time frame: baseline, 3 months, 12 months
Plan to share: No
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Duke University