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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03339440
Other study ID # Pro00086684
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 10, 2018
Est. completion date June 30, 2021

Study information

Verified date October 2021
Source Duke University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Completed
Enrollment 327
Est. completion date June 30, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 5 Years to 18 Years
Eligibility 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.

Study Design


Intervention

Behavioral:
Hearts & Parks
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.

Locations

Country Name City State
United States 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

Sponsors (1)

Lead Sponsor Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

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