Clinical trial NCT03246763: Active Recreation Through Community-Healthcare Engagement Study
Official title: Active Recreation Through Community-Healthcare Engagement Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity
Quality of Life
Keywords: childhood obesity
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2017-08-11
Enrollment: 202
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Eligibility
timeFrame: Baseline
measure: Referral
timeFrame: Baseline
measure: Enrollment
timeFrame: Baseline
measure: Attendance
timeFrame: Through study completion, average of 1 year
measure: Fidelity
timeFrame: Through study completion, average of 1 year
measure: Change in quality of life
timeFrame: Baseline, 6 months, 12 months
measure: Change in height
timeFrame: 0 months, 3 months, 6 months, 12 months
measure: Change in nutrition habits (self report)
timeFrame: 0 months, 3 months, 6 months, 12 months
measure: Food insecurity
timeFrame: Baseline
measure: Change in cardiovascular fitness
timeFrame: 0 months, 3 months, 6 months
measure: Patient satisfaction
timeFrame: 6 months
measure: Change in social cohesion
timeFrame: 3 months, 6 months
measure: Change in weight
timeFrame: 0 months, 3 months, 6 months, 12 months
measure: Change in activity (self report)
timeFrame: 0 months, 3 months, 6 months, 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Biscoe
country: United States
facility: First Health
state: North Carolina
city: Durham
country: United States
facility: East Durham Children's Initiative
state: North Carolina
city: Durham
country: United States
facility: Duke Healthy Lifestyles
state: North Carolina
city: Fayetteville
country: United States
facility: Better Health
state: North Carolina
city: Goldsboro
country: United States
facility: Goldsboro Parks and Recreation
state: North Carolina
city: Raleigh
country: United States
facility: Wake Med
state: North Carolina
city: Salisbury
country: United States
facility: Healthy Rowan
state: North Carolina
Study officials:
References:
citation: Alexander E, Skinner A, Gaskin K, Jones J, Wong C, Loflin C, Fleming R, Howard J, Armstrong S, Neshteruk C. A Mixed-Methods Examination of Referral Processes to Clinic-Community Partnership Programs for the Treatment of Childhood Obesity. Child Obes. 2021 Dec;17(8):516-524. doi: 10.1089/chi.2020.0361. Epub 2021 Jul 5.