Parks & Pediatrics Fit Together

N/AActive Not RecruitingNCT05455190

Duke University400 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

400

Conditions

Pediatric Obesity Implementation

Interventions

Fit TogetherBEHAVIORAL

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.

Educational materialsBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 5 YearsMax age: 12 Years

Medical Language ↔ Plain English

Winston-Salem \& Charlotte Cohorts: Inclusion Criteria: * Child receives primary care at one of the participating clinics * 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%ile 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 move out of the area during the duration of the study (12 months) Durham Cohort: Inclusion Criteria: * Child is a Healthy Lifestyles patient and has been referred to Bull City Fit * Child is 5-12 years old at the time of enrollment in the study Child BMI is greater than or equal to the 95th %ile (An exception may be made if BMI is now below the 95th%ile, but was \> 95th%ile at the time they started attending Healthy Lifestyles/Bull City Fit. An exception may also be made if BMI was below the 95th%ile but \> 85th%ile and obesity treatment/program participation is clinically indicated (e.g., provider still referred them to Healthy Lifestyles and their HL provider referred them to BCF)) * Child and parent are English- or Spanish-speaking * Child does not have an injury or disability preventing them for engaging in physical activity -- if a child meets this exclusion criteria at the time of referral but is expected to recover/heal (e.g., sprained ankle), they may enroll once healed and cleared to resume physical activity. * Caregiver age 18 or older * Caregiver anticipates bringing the child to the program the majority of the time and spends significant time with the child outside of program hours * Does not have plans to move out of the area during the next 6 months If multiple siblings from one household are eligible and would like to participate, more than one child may be enrolled.

Locations (3)

Michael Jordan Family Medical Clinic (Freedom Drive Location) (NHPMCF)

Charlotte, North Carolina, United States

Duke University

Durham, North Carolina, United States

Waughtown Pediatrics (NHFMCF)

Winston-Salem, North Carolina, United States

Outcomes

Primary Outcomes

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

Time frame: Baseline, 3 months, 6 months, and 12 months

Proportion of children with 26 hours or more of intervention contact

Measured by program attendance

Time frame: 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

Time frame: Baseline up to 12 months

Secondary Outcomes

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

Time frame: Baseline, 6 months, and 12 months

Change in quality of life

Measured by Sizing Them Up; Scoring: range 0-100, higher scores indicate better health-related quality of life

Time frame: Baseline, 6 months, and 12 months

Unintended Consequences as measured by adverse events

Measured by collecting adverse events throughout participation

Time frame: Up to 12 months

Patient Satisfaction at 3 months

Measured by satisfaction survey; Scoring: ranging 5-25, higher scores indicate higher satisfaction

Data from ClinicalTrials.gov

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