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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03246763
Other study ID # Pro00084070
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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