Parks & Pediatrics Fit Together
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Fit Together Participants in the intervention arm will receive standard of care obesity treatment from their provider and be able to participate in the Fit Together program and attend activity sessions throughout the duration of their 12 month participation. |
Behavioral: Fit Together
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.
|
| Active Comparator: Control Participants in the control arm will receive standard of care obesity treatment from their provider and a healthy cooking magazine mailed to them at a regular interval throughout the duration of their 12 month participation |
Behavioral: Educational materials
Participants will receive a child-friendly cooking magazine mailed quarterly and a local Parks and Recreation program guide.
|
Outcome Measures
Primary Outcome Measures
- Change in percent of the 95th percentile for BMI Collected from clinic records. [Baseline, 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
- Proportion of children with 26 hours or more of intervention contact [Up to 12 months]
Measured by program attendance
- Change in number of combined minutes per day of moderate and vigorous physical activity, as measured by Garmin vivofit4 fitness tracker [Baseline up to 12 months]
Change in physical activity measured by Garmin vivofit4 fitness tracker
Secondary Outcome Measures
- Change in self-report physical activity [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
- Change in quality of life [Baseline, 6 months, and 12 months]
Measured by Sizing Them Up; Scoring: range 0-100, higher scores indicate better health-related quality of life
- Unintended Consequences as measured by adverse events [Up to 12 months]
Measured by collecting adverse events throughout participation
- Patient Satisfaction at 6 months [6 months]
Measured by satisfaction survey; Scoring: ranging 5-25, higher scores indicate higher satisfaction
- Patient Satisfaction at 12 months [12 months]
Measured by satisfaction survey; Scoring: ranging 5-25, higher scores indicate higher satisfaction
- Change in diet quality [Baseline, 6 months, 12 months]
Measured by the Dietary Screener Questionnaire (DSQ)
- Healthcare utilization [Up to 12 months]
Measured by electronic health records
- Cost effects [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.
Other Outcome Measures
- Fidelity [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)
- Implementation characteristics [Throughout program implementation duration (approx. 30 months)]
Barriers and facilitators to implementation collected via survey and qualitative interviews with stakeholders
- Assessment of harms related to the program [Up through 12 months]
Measured by assessment of harms survey; Scoring: ranging 5-25, higher scores indicate higher harms
- Change in mental health [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
- Change in blood pressure [Baseline, 6 months, 12 months]
Obtained from medical records
- Proportion of eligible children referred to the intervention [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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Child receives primary care at one of the participating clinics
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Child age 6-11 years old at the time of enrollment in the study
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BMI greater than or equal to 95th percentile for age and sex
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English- or Spanish-speaking
Exclusion Criteria:
- BMI above 160% of 95th percentile
Inclusion criteria for caregivers:
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Age 18 or older
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English or Spanish-speaking
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Caregiver has smartphone and is willing to download app(s) used in the study
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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)
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Does not have plans to leave the area during the next 12 months
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Duke University
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Pro00106453
- 1R01HD100417-01A1