Parks & Pediatrics Fit Together

Pediatric Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05455190
• Other study ID #: Pro00106453
• Secondary ID: 1R01HD100417-01A
• Status: Recruiting
• Phase: N/A
• Start date: December 15, 2022
• Est. completion date: December 1, 2025

Study information

• Verified date: May 2023
• Source: Duke University
• Contact: Valery R Arevalo
• Phone: 9198668089
• Email: valery.arevalo[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Implementation
• Obesity
• Pediatric Obesity

Intervention

Behavioral:
• 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.
• Educational materials
Participants will receive a child-friendly cooking magazine mailed quarterly and a local Parks and Recreation program guide.

Locations

Country	Name	City	State
United States	Michael Jordan Family Medical Clinic (Freedom Drive Location) (NHPMCF)	Charlotte	North Carolina
United States	Waughtown Pediatrics (NHFMCF)	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fidelity	Degree to which the program was implemented as intended. Collected via structured observations of program sessions using System for Observing Play and Leisure Activity in Youth (SOPLAY)	Throughout program implementation duration (approx. 30 months)
Other	Implementation characteristics	Barriers and facilitators to implementation collected via survey and qualitative interviews with stakeholders	Throughout program implementation duration (approx. 30 months)
Other	Assessment of harms related to the program	Measured by assessment of harms survey; Scoring: ranging 5-25, higher scores indicate higher harms	Up through 12 months
Other	Change in mental health	Measured by Pediatric Symptom Checklist (PSC-17); Scoring: range 0-34, higher scores can indicate increased likelihood of behavioral health disorder	Baseline, 6 months, 12 months
Other	Change in blood pressure	Obtained from medical records	Baseline, 6 months, 12 months
Other	Proportion of eligible children referred to the intervention	Proportion of eligible children who are referred to the intervention, collected via program tracking materials/referrals received and EHR	Up through end of enrollment period (approx. 18 months)
Primary	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
Primary	Proportion of children with 26 hours or more of intervention contact	Measured by program attendance	Up to 12 months
Primary	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	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
Secondary	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
Secondary	Unintended Consequences as measured by adverse events	Measured by collecting adverse events throughout participation	Up to 12 months
Secondary	Patient Satisfaction at 6 months	Measured by satisfaction survey; Scoring: ranging 5-25, higher scores indicate higher satisfaction	6 months
Secondary	Patient Satisfaction at 12 months	Measured by satisfaction survey; Scoring: ranging 5-25, higher scores indicate higher satisfaction	12 months
Secondary	Change in diet quality	Measured by the Dietary Screener Questionnaire (DSQ)	Baseline, 6 months, 12 months
Secondary	Healthcare utilization	Measured by electronic health records	Up to 12 months
Secondary	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)