Parks & Pediatrics Fit Together

Not Applicable

Recruiting

• Conditions: Pediatric Obesity; Implementation

• Registration Number: NCT05455190
• Lead Sponsor: Duke University

Brief Summary

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.

Detailed Description

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 we will study implementation outcomes as well as 12-month patient outcomes. We have added a local cohort in Durham, North Carolina, where their local Fit Together model has re-started their community activity program, and we will look at 6-month patient outcomes.

Study Timeline

• Study First Submitted: 2022-07-01
• Study First Submitted QC: 2022-07-07
• Study First Posted: 2022-07-13
• Study Start: 2022-12-15
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-25
• Last Update Posted: 2025-07-29
• Primary Completion: 2026-05-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Child receives primary care at one of the participating clinics or attends Bull City Fit
• Child age 5-12 years old at the time of enrollment in the study
• BMI greater than or equal to 95th percentile for age and sex (or greater than or equal to 85th%iile at the discretion of the provider)
• English- or Spanish-speaking

Exclusion Criteria

• Injuries or disabilities preventing physical activity.

Inclusion criteria for caregivers:

• Age 18 or older
• English or Spanish-speaking
• Caregiver has smartphone and is willing to download app(s) used in the study
• Anticipates bringing the child to the program the majority of the time and spends significant time with the child outside of program hours (necessary in order to accurately answer survey questions about child behavior and child participation in the program, and provide feedback about the program)
• Does not have plans to leave the area during the duration of the study (12 months for Winston Salem/Charlotte participants, 6 months for Bull City Fit cohort)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Proportion of children with 26 hours or more of intervention contact	Up to 12 months	Measured by program attendance
Change in percent of the 95th percentile for BMI Collected from clinic records.	Baseline, 6 months, and 12 months	Change in child's BMI, based on percent of the 95th percentile, measured using height and weight collected from clinic/medical records
Change in number of combined minutes per day of moderate and vigorous physical activity, as measured by Garmin vivofit4 fitness tracker	Baseline up to 12 months	Change in physical activity measured by Garmin vivofit4 fitness tracker

Secondary Outcome Measures

Name	Time	Method
Change in self-report physical activity	Baseline, 6 months, and 12 months	Measured by the Evaluation of Activity Surveys in Youth (EASY); Scoring: range 0-88, higher scores indicate more activity
Unintended Consequences as measured by adverse events	Up to 12 months	Measured by collecting adverse events throughout participation
Change in diet quality	Baseline, 6 months, 12 months	Measured by the Dietary Screener Questionnaire (DSQ)
Healthcare utilization	Up to 12 months	Measured by electronic health records
Change in quality of life	Baseline, 6 months, and 12 months	Measured by Sizing Them Up; Scoring: range 0-100, higher scores indicate better health-related quality of life
Patient Satisfaction at 6 months	6 months	Measured by satisfaction survey; Scoring: ranging 5-25, higher scores indicate higher satisfaction
Patient Satisfaction at 12 months	12 months	Measured by satisfaction survey; Scoring: ranging 5-25, higher scores indicate higher satisfaction
Cost effects	Throughout program implementation duration (approx. 30 months)	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.

Trial Locations

Locations (2)

Michael Jordan Family Medical Clinic (Freedom Drive Location) (NHPMCF); 🇺🇸 Charlotte, North Carolina, United States

Waughtown Pediatrics (NHFMCF); 🇺🇸 Winston-Salem, North Carolina, United States