A Trial of an Integrated Clinic-community Intervention in Children and Adolescents With Obesity (Hearts and Parks)
NCT ID: NCT03339440
Last Updated: 2021-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
327 participants
INTERVENTIONAL
2018-01-10
2021-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Intervention Group
Patients in this group will be receiving the Hearts and Parks intervention.
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.
Control Group
Patients in this group will continue receiving standard of care.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
5 Years
18 Years
ALL
Yes
Sponsors
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Duke University
OTHER
Responsible Party
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Principal Investigators
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Sarah Armstrong, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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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, United States
Countries
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References
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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.
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.
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.
Other Identifiers
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Pro00086684
Identifier Type: -
Identifier Source: org_study_id