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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Patients in this group will be receiving the Hearts and Parks intervention. |
|
| Control Group | No Intervention | Patients in this group will continue receiving standard of care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Armstrong, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Children's Primary Care Roxboro Street | Durham | North Carolina | 27704 | United States | ||
| Durham Pediatrics at North Duke Street |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41903777 | Derived | 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. | |
| 38493216 | Derived |
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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.
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|
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 |
| Durham |
| North Carolina |
| 27704 |
| United States |
| Regional Pediatrics - North Durham | Durham | North Carolina | 27704 | United States |
| 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. |
| 37790374 | 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. |
| 33902326 | 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. |
| 32590958 | 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. |
| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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