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

NCT03339440 | Completed

• 1 other identifier: Pro00086684
• Study Type: interventional
• Target: 327
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Outcome Measures

Primary Outcomes (13)

• 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

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Behavioral: Hearts & Parks

Control Group

NO INTERVENTION

Patients in this group will continue receiving standard of care.

Interventions

Hearts & Parks BEHAVIORAL

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.

Intervention Group

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead

Study Sites (3)

Duke Children's Primary Care Roxboro Street

Durham, North Carolina, 27704, United States

Location

Durham Pediatrics at North Duke Street

Durham, North Carolina, 27704, United States

Location

Regional Pediatrics - North Durham

Durham, North Carolina, 27704, United States

Location

Related Publications (4)

• Singh K, Armstrong SC, Wagner BE, Counts J, Skinner A, Kay M, Li JS, Shah S, Zucker N, Neshteruk C, Story M, Suarez L, Kraus WE, Zizzi AR, Dunn J. Physical activity and sleep changes among children during the COVID-19 pandemic. NPJ Digit Med. 2024 Mar 16;7(1):70. doi: 10.1038/s41746-024-01041-8.

  PMID: 38493216 DERIVED

• Dunn J, Singh K, Armstrong S, Wagner B, Counts J, Skinner A, Kay M, Li J, Shah S, Zucker N, Neshteruk C, Suarez L, Kraus W, Zizzi A. Physical activity and sleep changes among children with obesity during a period of school closures related to the COVID-19 pandemic. Res Sq [Preprint]. 2023 Sep 13:rs.3.rs-3293474. doi: 10.21203/rs.3.rs-3293474/v1.

  PMID: 37790374 DERIVED

• 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.

  PMID: 33902326 DERIVED

• 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.

  PMID: 32590958 DERIVED

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sarah Armstrong, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 30, 2017
• First Posted: November 13, 2017
• Study Start: January 10, 2018
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: November 4, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)