Clinical trial NCT05455190: Parks & Pediatrics Fit Together
Official title: Parks & Pediatrics Fit Together: Translating Knowledge Into Action for Child Obesity Treatment in Partnership With Parks and Recreation
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Pediatric Obesity
Implementation
Keywords: Physical Activity
Pediatrics
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2022-07-13
Enrollment: 400
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* Child receives primary care at one of the participating clinics
* Child age 6-11 years old at the time of enrollment in the study
* BMI greater than or equal to 95th percentile for age and sex
* 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 leave the area during the next 12 months

Primary outcomes:
measure: Change in percent of the 95th percentile for BMI Collected from clinic records.
timeFrame: Baseline, 6 months, and 12 months
measure: Proportion of children with 26 hours or more of intervention contact
timeFrame: Up to 12 months
measure: Change in number of combined minutes per day of moderate and vigorous physical activity, as measured by Garmin vivofit4 fitness tracker
timeFrame: Baseline up to 12 months
Secondary outcomes:
measure: Change in self-report physical activity
timeFrame: Baseline, 6 months, and 12 months
measure: Change in quality of life
timeFrame: Baseline, 6 months, and 12 months
measure: Unintended Consequences as measured by adverse events
timeFrame: Up to 12 months
measure: Patient Satisfaction at 6 months
timeFrame: 6 months
measure: Patient Satisfaction at 12 months
timeFrame: 12 months
measure: Change in diet quality
timeFrame: Baseline, 6 months, 12 months
measure: Healthcare utilization
timeFrame: Up to 12 months
measure: Cost effects
timeFrame: Throughout program implementation duration (approx. 30 months)
Other outcomes:
measure: Fidelity
timeFrame: Throughout program implementation duration (approx. 30 months)
measure: Implementation characteristics
timeFrame: Throughout program implementation duration (approx. 30 months)
measure: Assessment of harms related to the program
timeFrame: Up through 12 months
measure: Change in mental health
timeFrame: Baseline, 6 months, 12 months
measure: Change in blood pressure
timeFrame: Baseline, 6 months, 12 months
measure: Proportion of eligible children referred to the intervention
timeFrame: Up through end of enrollment period (approx. 18 months)
Locations:
city: Charlotte
country: United States
facility: Michael Jordan Family Medical Clinic (Freedom Drive Location) (NHPMCF)
state: North Carolina
city: Winston-Salem
country: United States
facility: Waughtown Pediatrics (NHFMCF)
state: North Carolina
Study officials:
References: