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OpenTrials
Active, Not Recruiting

NCT Number: NCT05455190

Parks & Pediatrics Fit Together

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Michael Jordan Family Medical Clinic (Freedom Drive Location) (NHPMCF), Charlotte, North Carolina, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Educational materials

Behavioral

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

Primary outcomes

  1. Change in percent of the 95th percentile for BMI Collected from clinic records.

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

    Change in child's BMI, based on percent of the 95th percentile, measured using height and weight collected from clinic/medical records

  2. Proportion of children with 26 hours or more of intervention contact

    Time frame: Up to 12 months

    Measured by program attendance

  3. Change in number of combined minutes per day of moderate and vigorous physical activity, as measured by Garmin vivofit4 fitness tracker

    Time frame: Baseline up to 12 months

    Change in physical activity measured by Garmin vivofit4 fitness tracker

Secondary outcomes

  1. Change in self-report physical activity

    Time frame: Baseline, 6 months, and 12 months

    Measured by the Evaluation of Activity Surveys in Youth (EASY); Scoring: range 0-88, higher scores indicate more activity

  2. Change in quality of life

    Time frame: Baseline, 6 months, and 12 months

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

  3. Unintended Consequences as measured by adverse events

    Time frame: Up to 12 months

    Measured by collecting adverse events throughout participation

  4. Patient Satisfaction at 3 months

    Time frame: 3 months

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

  5. Patient Satisfaction at 6 months

    Time frame: 6 months

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

  6. Patient Satisfaction at 12 months

    Time frame: 12 months

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

  7. Change in diet quality

    Time frame: Baseline, 6 months, 12 months

    Measured by the Dietary Screener Questionnaire (DSQ)

  8. Physical activity during program sessions measured by accelerometer

    Time frame: 6 months

    Measured by the average number of minutes of moderate to vigorous physical activity (MVPA) per session.

Other outcomes

  1. Fidelity

    Time frame: Throughout program implementation duration (approx. 30 months)

    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)

  2. Implementation characteristics

    Time frame: Throughout program implementation duration (approx. 30 months)

    Barriers and facilitators to implementation collected via survey and qualitative interviews with stakeholders

  3. Assessment of harms related to the program

    Time frame: Up through 12 months

    Measured by assessment of harms survey; Scoring: ranging 5-25, higher scores indicate higher harms

  4. Change in mental health

    Time frame: Baseline, 6 months, 12 months

    Measured by Pediatric Symptom Checklist (PSC-17); Scoring: range 0-34, higher scores can indicate increased likelihood of behavioral health disorder

  5. Change in blood pressure

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

    Obtained from medical records

  6. Proportion of eligible children referred to the intervention

    Time frame: Up through end of enrollment period (approx. 18 months)

    Proportion of eligible children who are referred to the intervention, collected via program tracking materials/referrals received and EHR

  7. Proportion of referred children who attended the intervention at least once

    Time frame: Up through end of enrollment period (approx. 18 months)

    Proportion of children referred to the program who attended at least once, collected via program tracking materials/referrals received and EHR

  8. Healthcare utilization

    Time frame: Up to 12 months

    Measured by electronic health records

  9. Cost effects

    Time frame: Throughout program implementation duration (approx. 30 months)

    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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jul 13, 2022
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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