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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03339440
• Other study ID #: Pro00086684
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Cardiovascular Risk Factor
• Childhood Obesity
• Obesity
• Pediatric Obesity
• Quality of Life

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