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Childhood ObesityNCT03339440

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

A study testing Hearts & Parks in people with Childhood Obesity and Pediatric Obesity, run by Duke University at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 5 to 18 yearsHealthy volunteers can take part
What is being tested?
Hearts & Parks
Could I receive a placebo?
No, everyone receives an active treatment
How many people
327 participants
Where
3 sitesUnited States
Study dates
10 Jan 2018to 30 Jun 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 9Show fewer
  • 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.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Duke Children's Primary Care Roxboro Street

    Durham, North Carolina, 27704

  • Durham Pediatrics at North Duke Street

    Durham, North Carolina, 27704

  • Regional Pediatrics - North Durham

    Durham, North Carolina, 27704

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Hearts & Parks
Medical subject headings
Pediatric Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hearts & ParksBehavioural

    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.

Study groups in NCT03339440
Study groupRoleWhat they receive
Intervention GroupExperimentalPatients in this group will be receiving the Hearts and Parks intervention.
Receives: Behavioral: Hearts & Parks
Control GroupNo interventionPatients in this group will continue receiving standard of care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in z-BMI

    Measured: Baseline, 6 months

  2. Change in heart rate

    Measured: baseline, 12 months

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

    As measured by enrollment logs

    Measured: 12 months

  4. Change in molecular pathways dysregulated in pediatric obesity

    Stool and blood samples

    Measured: Baseline, 6 months

  5. Physical activity

    child physical activity; objectively tracked with fitness tracker

    Measured: Up to 12 months

  6. Change in child fitness

    3 minute bench stepping test

    Measured: baseline, 3 months, 12 months

  7. Change in Child Quality of Life

    Composite score of Sizing Me Up Questionnaires

    Measured: baseline, 3 months, 12 months

  8. Change in Body Appreciation

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

    Measured: baseline, 3 months, 12 months

  9. Change in FLASHE Food and Activity Screener Scores

    Questionnaire about child and parent nutrition and activity habits

    Measured: Baseline, 6 months, 12 months

  10. Change in fasting lipid profile

    Measured: Baseline, 6 months, 12 months

  11. Change in fasting glucose

    Measured: Baseline, 6 months, 12 months

  12. Change in alanine aminotransferase (A1)

    Measured: Baseline, 6 months, 12 months

  13. Change in child quality of life (2)

    PROMIS Questionnaire (not composite score)

    Measured: baseline, 3 months, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2017
  2. Study start10 Jan 2018
  3. Primary completion30 Jun 2021
  4. Study completion30 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
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)
Enrolment
327 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03339440
Sponsor's protocol ID
Pro00086684
Status last verified
Oct 2021
First submitted
30 Oct 2017
Last updated
4 Nov 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Scott AB, Armstrong S, Windom M, Li JS, Shah SH, Story M, Zucker N, Kraus WE, Zizzi AR, Schwark Ii E, Skinner AC, Neshteruk CD. The Feasibility of Using Best Practice Alerts in Pediatric Primary Care for Obesity Research. Acad Pediatr. 2026 May-Jun;26(4):103310. doi: 10.1016/j.acap.2026.103310. Epub 2026 Mar 26.

    PubMed 41903777

  • 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.

    PubMed 38493216

  • 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.

    PubMed 37790374

  • 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.

    PubMed 33902326

  • 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.

    PubMed 32590958

Questions about this trial

What is this clinical trial studying?

A study testing Hearts & Parks in people with Childhood Obesity and Pediatric Obesity, run by Duke University at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in z-BMI (time frame: Baseline, 6 months). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03339440, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2021.

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