Parks & Pediatrics Fit Together

NCT05455190 | Active Not Recruiting

• 2 other identifiers: Pro001064531R01HD100417-01A1
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Pediatric Obesity; Implementation

Keywords

Physical Activity; Pediatrics

Outcome Measures

Primary Outcomes (3)

• 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

• 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 Outcomes (8)

• Change in self-report physical activity

  Baseline, 6 months, and 12 months

• Change in quality of life

  Baseline, 6 months, and 12 months

• Unintended Consequences as measured by adverse events

  Up to 12 months

• Patient Satisfaction at 3 months

  3 months

• Patient Satisfaction at 6 months

  6 months

Other Outcomes (9)

• Fidelity

  Throughout program implementation duration (approx. 30 months)

• Implementation characteristics

  Throughout program implementation duration (approx. 30 months)

• Assessment of harms related to the program

  Up through 12 months

Study Arms (3)

Fit Together

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

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

Fit Together - BCF Cohort

EXPERIMENTAL

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

Interventions

Fit Together BEHAVIORAL

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.

Fit Together; Fit Together - BCF Cohort

Educational materials BEHAVIORAL

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

Control

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Injuries or disabilities preventing physical activity.
• 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:
• 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
• 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.

Sponsors & Collaborators

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

Study Sites (3)

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

Charlotte, North Carolina, 28208, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Waughtown Pediatrics (NHFMCF)

Winston-Salem, North Carolina, 27107, United States

Location

Related Publications (2)

• 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.

  PMID: 37898741 DERIVED

• 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.

  PMID: 36829237 DERIVED

MeSH Terms

Conditions

Pediatric Obesity; Motor Activity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2022
• First Posted: July 13, 2022
• Study Start: December 15, 2022
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)