Active Recreation Through Community-Healthcare Engagement Study

Not Applicable

Completed

• Conditions: Childhood Obesity; Quality of Life
• Interventions: Behavioral: Integrated community-healthcare childhood obesity treatment

• 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.

Study Timeline

• Study First Submitted: 2017-08-04
• Study First Submitted QC: 2017-08-08
• Study First Posted: 2017-08-11
• Study Start: 2018-06-07
• Primary Completion: 2020-05-01
• Study Completion: 2020-05-01
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-13
• Last Update Posted: 2020-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 202

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Durham County	Integrated community-healthcare childhood obesity treatment	The intervention will include nutrition and fitness programming at a 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 comprehensive 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.
TBD	Integrated community-healthcare childhood obesity treatment	The intervention will include nutrition and fitness programming at a 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 comprehensive 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.
To be determined	Integrated community-healthcare childhood obesity treatment	The intervention will include nutrition and fitness programming at a 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 comprehensive 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.
Richmond/Montgomery Counties	Integrated community-healthcare childhood obesity treatment	The intervention will include nutrition and fitness programming at a 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 comprehensive 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.

Primary Outcome Measures

Name	Time	Method
Change in weight	0 months, 3 months, 6 months, 12 months
Eligibility	Baseline	Number of eligible patients
Change in social cohesion	3 months, 6 months	Measured by social cohesion questionnaire
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
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

Trial Locations

Locations (7)

Wake Med; 🇺🇸 Raleigh, North Carolina, United States

First Health; 🇺🇸 Biscoe, North Carolina, United States

East Durham Children's Initiative; 🇺🇸 Durham, North Carolina, United States

Healthy Rowan; 🇺🇸 Salisbury, 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