Parks & Pediatrics Fit Together

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pediatric Obesity; Implementation
• Intervention / Treatment: Behavioral: Fit Together; Behavioral: Educational materials

Detailed 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 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
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28208
      • Michael Jordan Family Medical Clinic (Freedom Drive Location) (NHPMCF)
    • Durham, North Carolina, United States, 27710
      • Duke University
    • Winston-Salem, North Carolina, United States, 27107
      • Waughtown Pediatrics (NHFMCF)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 11 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: 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	Behavioral: Educational materials; Participants will receive a child-friendly cooking magazine mailed quarterly and a local Parks and Recreation program guide.
Experimental: 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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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, 3 months, 6 months, and 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
Patient Satisfaction at 3 months	Measured by satisfaction survey; Scoring: ranging 5-25, higher scores indicate higher satisfaction	3 months
Physical activity during program sessions measured by accelerometer	Measured by the average number of minutes of moderate to vigorous physical activity (MVPA) per session.	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
Implementation characteristics	Barriers and facilitators to implementation collected via survey and qualitative interviews with stakeholders	Throughout program implementation duration (approx. 30 months)
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
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
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)
Change in blood pressure	Obtained from medical records	Baseline, 3 months, 6 months, 12 months
Proportion of referred children who attended the intervention at least once	Proportion of children referred to the program who attended at least once, collected via program tracking materials/referrals received and EHR	Up through end of enrollment period (approx. 18 months)

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Publications and helpful links

General Publications

• D'Agostino EM, Rosenberg LM, Richmond A, Damman A, Brown-Lowery C, Abbot-Grimes P, Siddiqui S, Fadika T, Ward M, Cooper M, Sutton S, Kenton L, Spaziano B, Kasper J, Barnes N, Hornik C. You & Me: Test and Treat study protocol for promoting COVID-19 test and treatment access to underserved populations. BMC Public Health. 2023 Oct 28;23(1):2121. doi: 10.1186/s12889-023-16960-6.
• Neshteruk CD, Skinner AC, Counts J, D'Agostino EM, Frerichs L, Howard J, Story M, Armstrong SC. Translating knowledge into action for child obesity treatment in partnership with Parks and Recreation: study protocol for a hybrid type II trial. Implement Sci. 2023 Feb 24;18(1):6. doi: 10.1186/s13012-023-01264-5.

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2022
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: July 1, 2022
• First Submitted That Met QC Criteria: July 7, 2022
• First Posted (Actual): July 13, 2022

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Physical Activity; Pediatrics
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Pathological Conditions, Signs and Symptoms; Behavior; Nutritional and Metabolic Diseases; Signs and Symptoms; Pediatric Obesity; Motor Activity
• Other Study ID Numbers: Pro00106453; 1R01HD100417-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No