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New program combines doctor visits and park activities to fight childhood obesity

NCT ID NCT05455190

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 18, 2026 · Updated 5 times

Summary

This study tests a program called Fit Together that combines standard medical care with community activity sessions for children with obesity. About 400 children aged 5-12 will receive a referral to local park programs offering exercise, sports, and nutrition activities. Researchers will measure changes in BMI and physical activity to see if this partnership model works.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Fit Together program (behavioral intervention: clinic care plus community activity sessions)
What this could lead to
If successful, this could provide a practical model for treating childhood obesity through clinic-community partnerships.
What could go wrong
This is an implementation study, not a test of a new drug. Results may vary by location and participation may be inconsistent.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

209 people

The number who actually took part.

Started

Dec 2022

Finished

Jul 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

5 to 12 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Motor Activity obesity disorder Pediatric Obesity

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Duke University

    Durham, North Carolina, 27710, United States

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

    Charlotte, North Carolina, 28208, United States

  • Waughtown Pediatrics (NHFMCF)

    Winston-Salem, North Carolina, 27107, United States

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