A Randomized Trial of an Integrated Clinic-community Intervention in Children and Adolescents With Obesity
Sponsor study identifier
interventional
327
1 country
3
Study Start
January 10, 2018
Actual (reported)Primary Completion
June 30, 2021
Actual (reported)Study Completion
June 30, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 30, 2017
Actual (reported)November 13, 2017
Actual (reported)January 10, 2018
Actual (reported)June 30, 2021
Actual (reported)June 30, 2021
Actual (reported)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
Patients in this group will be receiving the Hearts and Parks intervention.
Patients in this group will continue receiving standard of care.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Duke Children's Primary Care Roxboro Street
Durham, North Carolina, 27704, United States
Durham Pediatrics at North Duke Street
Durham, North Carolina, 27704, United States
Regional Pediatrics - North Durham
Durham, North Carolina, 27704, United States
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.
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.
Sarah Armstrong, MD
Duke University
327 participants (actual enrollment reported by the registry).
First Submitted
October 30, 2017
Group Telehealth Weight Management Visits for Adolescents With Obesity
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
Contact the study team to confirm eligibility.
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.
First Posted
November 13, 2017
Study Start
January 10, 2018
Actual (reported)Primary Completion
June 30, 2021
Actual (reported)Study Completion
June 30, 2021
Actual (reported)Last Updated
November 4, 2021
Record last verified: 2021-10
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Source: ClinicalTrials.gov.
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