Active Recreation Through Community-Healthcare Engagement Study

Quality of Life Clinical Trial

— ARCHES  

Official title:

Active Recreation Through Community-Healthcare Engagement Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03246763
• Other study ID #: Pro00084070
• Status: Completed
• Phase: N/A
• Start date: June 7, 2018
• Est. completion date: May 1, 2020

Study information

• Verified date: August 2020
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: May 1, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

Sampling:

• Patients enrolled by their physician in the clinic-community program

Inclusion:

• Child aged 2-17 years

• Child with age- and gender-specific BMI = 85th percentile

Exclusion:

• Inability to read and write in English or Spanish

• Parent with severe medical or mental health condition limiting ability to attend appointments

• Child with severe medical or mental health condition limiting ability to attend appointments or participate in behavioral therapies

• Parent and child live greater than 50 miles from the clinic and community center

• Plan to move out of state in the next 6 months, or plan to live in another state for 2 months or longer within the next 6 months (ex., summer vacation).

• Child with medical condition as cause of obesity (e.g., hypothyroidism, Cushing's Syndrome, Prader-Willi Syndrome, drug-induced obesity)

Related Conditions & MeSH terms

• Childhood Obesity
• Pediatric Obesity
• Quality of Life

Intervention

Behavioral:
• Integrated community-healthcare childhood obesity treatment
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.

Locations

Country	Name	City	State
United States	First Health	Biscoe	North Carolina
United States	Duke Healthy Lifestyles	Durham	North Carolina
United States	East Durham Children's Initiative	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

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eligibility	Number of eligible patients	Baseline
Primary	Referral	Number of referred patients	Baseline
Primary	Enrollment	Number of patients referred who enroll	Baseline
Primary	Attendance	Number of participants present at each activity session	Through study completion, average of 1 year
Primary	Fidelity	Measured by program post-session evaluation survey	Through study completion, average of 1 year
Primary	Change in quality of life	Measured by Sizing me Up survey	Baseline, 6 months, 12 months
Primary	Change in height		0 months, 3 months, 6 months, 12 months
Primary	Change in nutrition habits (self report)		0 months, 3 months, 6 months, 12 months
Primary	Food insecurity	Measured by The Hunger Vital Sign food insecurity assessment	Baseline
Primary	Change in cardiovascular fitness		0 months, 3 months, 6 months
Primary	Patient satisfaction	Measured by patient satisfaction survey	6 months
Primary	Change in social cohesion	Measured by social cohesion questionnaire	3 months, 6 months
Primary	Change in weight		0 months, 3 months, 6 months, 12 months
Primary	Change in activity (self report)		0 months, 3 months, 6 months, 12 months