Parks & Pediatrics Fit Together

Study Overview
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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.

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

Official Title
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Parks & Pediatrics Fit Together: Translating Knowledge Into Action for Child Obesity Treatment in Partnership With Parks and Recreation

Conditions
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Pediatric Obesity, Implementation

Intervention / Treatment
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* Behavioral: Fit Together
* Behavioral: Educational materials


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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 next 12 months

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fit Together<br>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. | Behavioral: Fit Together<br>* 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.<br>|
| Active Comparator: Control<br>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 | Behavioral: Educational materials<br>* Participants will receive a child-friendly cooking magazine mailed quarterly and a local Parks and Recreation program guide.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline, 6 months, and 12 months | 
| Proportion of children with 26 hours or more of intervention contact | Measured by program attendance | 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 | Baseline up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | Baseline, 6 months, and 12 months | 
| Unintended Consequences as measured by adverse events | Measured by collecting adverse events throughout participation | Up to 12 months | 
| Patient Satisfaction at 6 months | Measured by satisfaction survey; Scoring: ranging 5-25, higher scores indicate higher satisfaction | 6 months | 
| Patient Satisfaction at 12 months | Measured by satisfaction survey; Scoring: ranging 5-25, higher scores indicate higher satisfaction | 12 months | 
| Change in diet quality | Measured by the Dietary Screener Questionnaire (DSQ) | Baseline, 6 months, 12 months | 
| Healthcare utilization | Measured by electronic health records | Up to 12 months | 
| Cost effects | 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. | Throughout program implementation duration (approx. 30 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical Activity, Pediatrics