Parks & Pediatrics Fit Together (NCT05455190) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Parks & Pediatrics Fit Together
United States400 participantsStarted 2022-12-15
Plain-language 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.
Who can participate
Age range
5 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 cli…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in percent of the 95th percentile for BMI Collected from clinic records.
Timeframe: Baseline, 3 months, 6 months, and 12 months
2
Proportion of children with 26 hours or more of intervention contact
Timeframe: Up to 12 months
3
Change in number of combined minutes per day of moderate and vigorous physical activity, as measured by Garmin vivofit4 fitness tracker