Parks & Pediatrics Fit Together

Duke University

Status: Enrolling

Conditions: Implementation; Pediatric Obesity

Treatments: Behavioral: Educational materials; Behavioral: Fit Together

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05455190

Pro00106453

1R01HD100417-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 5 to 12 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 3 patient groups

Fit Together

Experimental group

Description:

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.

Treatment:

Behavioral: Fit Together

Control

Active Comparator group

Description:

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

Treatment:

Behavioral: Educational materials

Fit Together - BCF Cohort

Experimental group

Description:

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

Treatment:

Behavioral: Fit Together