Parks & Pediatrics Fit Together
- Conditions
- Pediatric ObesityImplementation
- Interventions
- Behavioral: Fit TogetherBehavioral: Educational materials
- 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
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 400
- Child receives primary care at one of the participating clinics
- Child age 6-11 years old at the time of enrollment in the study
- BMI greater than or equal to 95th percentile for age and sex
- English- or Spanish-speaking
- 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 next 12 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fit Together Fit Together 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. Control Educational materials 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
- 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
Patient Satisfaction at 12 months 12 months Measured by satisfaction survey; Scoring: ranging 5-25, higher scores indicate higher satisfaction
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
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