NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Parks & Pediatrics Fit Together

CompletedNA

Sponsor: Duke University

Conditions: Pediatric Obesity, Implementation

Interventions: Fit Together, Educational materials

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 5 Years to 12 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (3)

Charlotte, North Carolina, United States
Durham, North Carolina, United States
Winston-Salem, North Carolina, United States