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

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

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Pediatric Obesity; Childhood Obesity; Cardiovascular Risk Factor
• Intervention / Treatment: Behavioral: Hearts & Parks

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.

• Study Type: Interventional
• Enrollment (Actual): 327
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27704
      • Duke Children's Primary Care Roxboro Street
    • Durham, North Carolina, United States, 27704
      • Durham Pediatrics at North Duke Street
    • Durham, North Carolina, United States, 27704
      • Regional Pediatrics - North Durham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention Group; Patients in this group will be receiving the Hearts and Parks 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.
NO_INTERVENTION: Control Group; Patients in this group will continue receiving standard of care.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Sarah Armstrong, MD, Duke University

Publications and helpful links

General Publications

• Neshteruk CD, Zizzi A, Suarez L, Erickson E, Kraus WE, Li JS, Skinner AC, Story M, Zucker N, Armstrong SC. Weight-Related Behaviors of Children with Obesity during the COVID-19 Pandemic. Child Obes. 2021 Sep;17(6):371-378. doi: 10.1089/chi.2021.0038. Epub 2021 Apr 26.
• Armstrong SC, Windom M, Bihlmeyer NA, Li JS, Shah SH, Story M, Zucker N, Kraus WE, Pagidipati N, Peterson E, Wong C, Wiedemeier M, Sibley L, Berchuck SI, Merrill P, Zizzi A, Sarria C, Dressman HK, Rawls JF, Skinner AC. Rationale and design of "Hearts & Parks": study protocol for a pragmatic randomized clinical trial of an integrated clinic-community intervention to treat pediatric obesity. BMC Pediatr. 2020 Jun 26;20(1):308. doi: 10.1186/s12887-020-02190-x.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 10, 2018
• Primary Completion (ACTUAL): June 30, 2021
• Study Completion (ACTUAL): June 30, 2021

Study Registration Dates

• First Submitted: October 30, 2017
• First Submitted That Met QC Criteria: November 8, 2017
• First Posted (ACTUAL): November 13, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 4, 2021
• Last Update Submitted That Met QC Criteria: November 3, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: Pro00086684

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No