A Randomized Trial of an Integrated Clinic-community Intervention in Children and Adolescents With Obesity
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Childhood Obesity
- Sponsor
- Duke University
- Enrollment
- 327
- Locations
- 3
- Primary Endpoint
- Number of subjects enrolled versus number of subjects who meet min. participation criteria
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Number of subjects enrolled versus number of subjects who meet min. participation criteria
Time Frame: 12 months
As measured by enrollment logs
Change in z-BMI
Time Frame: Baseline, 6 months
Change in molecular pathways dysregulated in pediatric obesity
Time Frame: Baseline, 6 months
Stool and blood samples
Physical activity
Time Frame: Up to 12 months
child physical activity; objectively tracked with fitness tracker
Change in child fitness
Time Frame: baseline, 3 months, 12 months
3 minute bench stepping test
Change in Child Quality of Life
Time Frame: baseline, 3 months, 12 months
Composite score of Sizing Me Up Questionnaires
Change in Body Appreciation
Time Frame: 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
Time Frame: baseline, 12 months
Change in FLASHE Food and Activity Screener Scores
Time Frame: Baseline, 6 months, 12 months
Questionnaire about child and parent nutrition and activity habits
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)
Time Frame: baseline, 3 months, 12 months
PROMIS Questionnaire (not composite score)