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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HD100417-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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The proposed project will test an implementation strategy (the "TrailGuide") for delivering an existing model of pediatric obesity treatment ("Fit Together") that has demonstrated ability to meet published recommendations for improving health outcomes of children with obesity.
Evidence-based treatment for childhood obesity exists, yet a fundamental knowledge-to-action gap has significantly limited the uptake of recommendations into clinical practice, particularly in low-income settings. Persistence of this gap represents a large-scale public health threat, as the earliest generation of children living through the obesity epidemic now enters adulthood, they are the first in US history to have a shorter life expectancy than their parents, mainly due to rising rates of obesity-related cancers and cardiovascular disease. A central challenge in delivering recommended treatment is the intensity; ≥26 hours of face-to-face contact are necessary to achieve health benefits and risk reduction. The objective of the proposed project is to develop and test an implementation strategy that pairs primary care pediatric clinics with the municipal Parks and Recreation (P&R) centers to deliver the current treatment recommendations with high fidelity, while allowing while allowing crucial adaptations for the local and cultural context. Using the Fit Together model, the clinical partner provides standard medical treatment for pediatric obesity, while the community partner (typically parks and recreation) provides space facilitating the activity/nutrition sessions specifically for children referred from the clinic, along with their families. Fit Together will be implemented in two new communities in North Carolina, and investigators will study implementation outcomes as well as 12-month patient outcomes. A local cohort has been added in Durham, North Carolina, where their local Fit Together model has re-started their community activity program, and investigators will look at 6-month patient outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fit Together | Experimental | Participants in the intervention arm will receive standard of care obesity treatment from their provider and be able to participate in the Fit Together program and attend activity sessions throughout the duration of their 12 month participation. |
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| Control | Active Comparator | Participants in the control arm will receive standard of care obesity treatment from their provider and a healthy cooking magazine mailed to them at a regular interval throughout the duration of their 12 month participation |
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| Fit Together - BCF Cohort | Experimental | Participants in the Fit Together - BCF Cohort arm will receive standard of care obesity treatment at the Duke Healthy Lifestyles clinic and attend Bull City Fit throughout the duration of their 6 month participation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fit Together | Behavioral | Fit Together intervention follows a clinic and community partnership model for childhood obesity treatment. Children with obesity will receive standard of care obesity treatment from their usual provider and will also receive a referral to an activity program run out of the local community center. Each session delivers a combination of high-intensity individual exercises, sports and games, and unstructured playtime to help children reach the US Physical Activity guidelines of 60min moderate-to-vigorous physical activity daily. There will also be a nutrition activity session offered regularly. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in percent of the 95th percentile for BMI Collected from clinic records. | Change in child's BMI, based on percent of the 95th percentile, measured using height and weight collected from clinic/medical records | Baseline, 3 months, 6 months, and 12 months |
| Proportion of children with 26 hours or more of intervention contact | Measured by program attendance | Up to 12 months |
| Change in number of combined minutes per day of moderate and vigorous physical activity, as measured by Garmin vivofit4 fitness tracker | Change in physical activity measured by Garmin vivofit4 fitness tracker | Baseline up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in self-report physical activity | Measured by the Evaluation of Activity Surveys in Youth (EASY); Scoring: range 0-88, higher scores indicate more activity | Baseline, 6 months, and 12 months |
| Change in quality of life |
| Measure | Description | Time Frame |
|---|---|---|
| Fidelity | Degree to which the program was implemented as intended. Collected via structured observations of program sessions using System for Observing Play and Leisure Activity in Youth (SOPLAY) | Throughout program implementation duration (approx. 30 months) |
| Implementation characteristics |
Winston-Salem & Charlotte Cohorts:
Inclusion Criteria:
Exclusion Criteria:
Inclusion criteria for caregivers:
Durham Cohort:
Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Michael Jordan Family Medical Clinic (Freedom Drive Location) (NHPMCF) | Charlotte | North Carolina | 28208 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37898741 | Derived | D'Agostino EM, Rosenberg LM, Richmond A, Damman A, Brown-Lowery C, Abbot-Grimes P, Siddiqui S, Fadika T, Ward M, Cooper M, Sutton S, Kenton L, Spaziano B, Kasper J, Barnes N, Hornik C. You & Me: Test and Treat study protocol for promoting COVID-19 test and treatment access to underserved populations. BMC Public Health. 2023 Oct 28;23(1):2121. doi: 10.1186/s12889-023-16960-6. | |
| 36829237 | Derived | Neshteruk CD, Skinner AC, Counts J, D'Agostino EM, Frerichs L, Howard J, Story M, Armstrong SC. Translating knowledge into action for child obesity treatment in partnership with Parks and Recreation: study protocol for a hybrid type II trial. Implement Sci. 2023 Feb 24;18(1):6. doi: 10.1186/s13012-023-01264-5. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Nov 13, 2025 | Mar 16, 2026 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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|
| Educational materials | Behavioral | Participants will receive a child-friendly cooking magazine mailed quarterly and a local Parks and Recreation program guide. |
|
Measured by Sizing Them Up; Scoring: range 0-100, higher scores indicate better health-related quality of life
| Baseline, 6 months, and 12 months |
| Unintended Consequences as measured by adverse events | Measured by collecting adverse events throughout participation | Up to 12 months |
| Patient Satisfaction at 3 months | Measured by satisfaction survey; Scoring: ranging 5-25, higher scores indicate higher satisfaction | 3 months |
| Patient Satisfaction at 6 months | Measured by satisfaction survey; Scoring: ranging 5-25, higher scores indicate higher satisfaction | 6 months |
| Patient Satisfaction at 12 months | Measured by satisfaction survey; Scoring: ranging 5-25, higher scores indicate higher satisfaction | 12 months |
| Change in diet quality | Measured by the Dietary Screener Questionnaire (DSQ) | Baseline, 6 months, 12 months |
| Physical activity during program sessions measured by accelerometer | Measured by the average number of minutes of moderate to vigorous physical activity (MVPA) per session. | 6 months |
Barriers and facilitators to implementation collected via survey and qualitative interviews with stakeholders |
| Throughout program implementation duration (approx. 30 months) |
| Assessment of harms related to the program | Measured by assessment of harms survey; Scoring: ranging 5-25, higher scores indicate higher harms | Up through 12 months |
| Change in mental health | Measured by Pediatric Symptom Checklist (PSC-17); Scoring: range 0-34, higher scores can indicate increased likelihood of behavioral health disorder | Baseline, 6 months, 12 months |
| Change in blood pressure | Obtained from medical records | Baseline, 3 months, 6 months, 12 months |
| Proportion of eligible children referred to the intervention | Proportion of eligible children who are referred to the intervention, collected via program tracking materials/referrals received and EHR | Up through end of enrollment period (approx. 18 months) |
| Proportion of referred children who attended the intervention at least once | Proportion of children referred to the program who attended at least once, collected via program tracking materials/referrals received and EHR | Up through end of enrollment period (approx. 18 months) |
| Healthcare utilization | Measured by electronic health records | Up to 12 months |
| Cost effects | Cost impact (summative or incremental) to the unit or organization resulting from changes in health care utilization and efficiency. Fixed and variable costs; offsets of the cost of implementation. Collected as project administrative data, surveys with clinics and P&R sites to assess additional costs. | Throughout program implementation duration (approx. 30 months) |
| Duke University |
| Durham |
| North Carolina |
| 27710 |
| United States |
| Waughtown Pediatrics (NHFMCF) | Winston-Salem | North Carolina | 27107 | United States |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |