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

Primary Purpose

Childhood Obesity, Pediatric Obesity, Quality of Life

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Hearts & Parks

About this trial

This is an interventional treatment trial for Childhood Obesity

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Duke Children's Primary Care Roxboro Street
Durham Pediatrics at North Duke Street
Regional Pediatrics - North Durham

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

Patients in this group will be receiving the Hearts and Parks intervention.

Patients in this group will continue receiving standard of care.

Outcomes

Primary Outcome Measures

Change in z-BMI

Change in heart rate

Number of subjects enrolled versus number of subjects who meet min. participation criteria

As measured by enrollment logs

Change in molecular pathways dysregulated in pediatric obesity

Stool and blood samples

Physical activity

child physical activity; objectively tracked with fitness tracker

Change in child fitness

3 minute bench stepping test

Change in Child Quality of Life

Composite score of Sizing Me Up Questionnaires

Change in Body Appreciation

Body appreciation scale 13-item questionnaire (1. Never, 2. Seldom, 3. Sometimes, 4. Often, 5. Always)

Change in FLASHE Food and Activity Screener Scores

Questionnaire about child and parent nutrition and activity habits

Change in fasting lipid profile

Change in fasting glucose

Change in alanine aminotransferase (A1)

Change in child quality of life (2)

PROMIS Questionnaire (not composite score)

Secondary Outcome Measures

Full Information

NCT ID

NCT03339440

First Posted

October 30, 2017

Last Updated

November 3, 2021

Sponsor

Duke University

1. Study Identification

Unique Protocol Identification Number

NCT03339440

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Completed

Study Start Date

January 10, 2018 (Actual)

Primary Completion Date

June 30, 2021 (Actual)

Study Completion Date

June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

The investigators will use a two-arm, randomized crossover controlled trial to compare routine primary care management of childhood obesity versus a novel clinic/family/community partnership program to treat childhood obesity. This design will allow for a randomized comparison of Group 1 (6-month standard control) to Group 2 (immediate 6-month intervention program) and to Group 3 (delayed crossover intervention on the standard control group). The design will also allow the investigators to observe intervention effects at 3 months in both intervention groups (Groups 2 and 3), and to track Group 2 for 6 additional months after active intervention to assess whether health benefits seen at 6 months were sustained to 12 months.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

327 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention Group

Arm Type

Experimental

Arm Description

Patients in this group will be receiving the Hearts and Parks intervention.

Arm Title

Control Group

Arm Type

No Intervention

Arm Description

Patients in this group will continue receiving standard of care.

Intervention Type

Behavioral

Intervention Name(s)

Hearts & Parks

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in z-BMI

Time Frame

Baseline, 6 months

Title

Change in heart rate

Time Frame

baseline, 12 months

Title

Number of subjects enrolled versus number of subjects who meet min. participation criteria

Description

As measured by enrollment logs

Time Frame

12 months

Title

Change in molecular pathways dysregulated in pediatric obesity

Description

Stool and blood samples

Time Frame

Baseline, 6 months

Title

Physical activity

Description

child physical activity; objectively tracked with fitness tracker

Time Frame

Up to 12 months

Title

Change in child fitness

Description

3 minute bench stepping test

Time Frame

baseline, 3 months, 12 months

Title

Change in Child Quality of Life

Description

Composite score of Sizing Me Up Questionnaires

Time Frame

baseline, 3 months, 12 months

Title

Change in Body Appreciation

Description

Body appreciation scale 13-item questionnaire (1. Never, 2. Seldom, 3. Sometimes, 4. Often, 5. Always)

Time Frame

baseline, 3 months, 12 months

Title

Change in FLASHE Food and Activity Screener Scores

Description

Questionnaire about child and parent nutrition and activity habits

Time Frame

Baseline, 6 months, 12 months

Title

Change in fasting lipid profile

Time Frame

Baseline, 6 months, 12 months

Title

Change in fasting glucose

Time Frame

Baseline, 6 months, 12 months

Title

Change in alanine aminotransferase (A1)

Time Frame

Baseline, 6 months, 12 months

Title

Change in child quality of life (2)

Description

PROMIS Questionnaire (not composite score)

Time Frame

baseline, 3 months, 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sarah Armstrong, MD

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Duke Children's Primary Care Roxboro Street

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27704

Country

United States

Facility Name

Durham Pediatrics at North Duke Street

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27704

Country

United States

Facility Name

Regional Pediatrics - North Durham

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27704

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33902326

Citation

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.

Results Reference

derived

PubMed Identifier

32590958

Citation

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.

Results Reference

derived

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

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