Parks & Pediatrics Fit Together

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-15

Study Completion Date

2026-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pediatric Obesity Implementation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fit Together - BCF Cohort

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

Group Type EXPERIMENTAL

Fit Together

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Fit Together

Intervention Type 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.

Control

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

Group Type ACTIVE_COMPARATOR

Educational materials

Intervention Type BEHAVIORAL

Participants will receive a child-friendly cooking magazine mailed quarterly and a local Parks and Recreation program guide.

Interventions

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Fit Together

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.

Intervention Type BEHAVIORAL

Educational materials

Participants will receive a child-friendly cooking magazine mailed quarterly and a local Parks and Recreation program guide.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

* 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)