Active Recreation Through Community-Healthcare Engagement Study
Condition: Childhood Obesity; Quality of Life
MeSH terms: Pediatric Obesity
Study type: Interventional

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.
    

Intervention name(s): Integrated community-healthcare childhood obesity treatment
Intervention type(s): Behavioral
Intervention description(s): The intervention will include nutrition and fitness programming at a local community center. The program will be open at least two sessions per week, each session lasting at least 1 hour. The program coordinator will run the programming, which will consist of wellness activities. Each session will include at least 60 minutes of exercise and/or active play, and each session will have an additional special "theme." For example, one session might include a cardio focused class, and one session might include a yoga class. The number and which sessions the participants attend each week is voluntary; clinic staff will recommend participation in as many sessions per week as possible. Participation is voluntary, and patients may opt-out at any time. Participants will be told that they can indicate to their provider or the program coordinator at any time either by phone or during the clinic appointment that they wish to opt-out of the study and its assessments.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: The investigators will conduct a mixed-methods study using focus groups and interviews to explore the facilitators and barriers to program implementation, and a time-series analysis to examine program engagement and individual health outcomes. This study design will be repeated at each of the four sites. Aim 1 will consent and enroll program providers to obtain qualitative feedback on program design and implementation; Aim 2 will collect de-identified program-level data on attendance and program components; Aim 3 will consent patients for individual-level baseline and outcomes data.Subjects will be enrolled at our community sites. A research assistant will conduct all the enrollment, consent, and data collection. Where needed, the investigators will report or obtain required IRB authorization agreements for each site, including Federal Wide Assurances, Data Transfer Agreements, or other documents as required by federal regulation.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: childhood obesity