Active Recreation Through Community-Healthcare Engagement Study
- Conditions
- Childhood ObesityQuality of Life
- Registration Number
- NCT03246763
- Lead Sponsor
- Duke University
- Brief Summary
Current obesity treatment guidelines recommend 26 or more hours of behavior treatment, delivered over a 6-month period in a multidisciplinary weight management clinic. However, this guideline is not feasible in real-world clinic settings where medical visits are costly and poorly reimbursed, and attrition is high, particularly among the most vulnerable children. The National Collaborative on Child Obesity Research has issued a call for research investigating healthcare-community partnerships to improve the effectiveness of child obesity treatment. The World Health Organization supports this approach, and in 2015 modified the chronic disease model to include healthcare-community integration. ARCHES is a three-year project that will develop and evaluate an effective, engaging, and scalable community-healthcare treatment option for low-income and racially diverse children. The project engages four communities in North Carolina and facilitates a local clinic-community partnership, supports the development of an integrated childhood obesity treatment program, and evaluates the feasibility of the integrated program model. The effectiveness of the integrated model will also be evaluated, as we will monitor patient outcomes associated with participation. Participation among teens (ages 11-18) will be incentivized where teen/caregiver dyads will be randomized to a gain or loss frame group at the beginning of the study and have the opportunity to receive and redeem points for attending sessions. Patient and process outcomes associated with participation in the integrated model with and without financial incentives will be evaluated.
- Detailed Description
The investigators propose a three-year project to evaluate the implementation feasibility and effectiveness of an integrated clinic-community model of child obesity treatment. The investigators will engage four communities in North Carolina, facilitate a local clinic-community partnership, support the development of an integrated child obesity treatment program, and monitor outcomes. To evaluate implementation feasibility the investigators will measure fidelity, reach, acceptability, uptake and cost. To evaluate the program model the investigators will conduct a classical program evaluation by monitoring aggregate referral, enrollment and attendance data, as well as safety and patient satisfaction. To report patient outcomes associated with participation in the integrated model, the investigators will measure participant-level outcomes over a 6-month period, including changes in nutrition and physical activity behaviors, quality of life, cardiovascular fitness, and body mass index.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 202
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Referral Baseline Number of referred patients
Enrollment Baseline Number of patients referred who enroll
Change in height 0 months, 3 months, 6 months, 12 months Change in social cohesion 3 months, 6 months Measured by social cohesion questionnaire
Change in weight 0 months, 3 months, 6 months, 12 months Eligibility Baseline Number of eligible patients
Patient satisfaction 6 months Measured by patient satisfaction survey
Change in activity (self report) 0 months, 3 months, 6 months, 12 months Attendance Through study completion, average of 1 year Number of participants present at each activity session
Fidelity Through study completion, average of 1 year Measured by program post-session evaluation survey
Change in nutrition habits (self report) 0 months, 3 months, 6 months, 12 months Change in cardiovascular fitness 0 months, 3 months, 6 months Change in quality of life Baseline, 6 months, 12 months Measured by Sizing me Up survey
Food insecurity Baseline Measured by The Hunger Vital Sign food insecurity assessment
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (7)
First Health
🇺🇸Biscoe, North Carolina, United States
East Durham Children's Initiative
🇺🇸Durham, North Carolina, United States
Duke Healthy Lifestyles
🇺🇸Durham, North Carolina, United States
Better Health
🇺🇸Fayetteville, North Carolina, United States
Goldsboro Parks and Recreation
🇺🇸Goldsboro, North Carolina, United States
Wake Med
🇺🇸Raleigh, North Carolina, United States
Healthy Rowan
🇺🇸Salisbury, North Carolina, United States
First Health🇺🇸Biscoe, North Carolina, United States