Active Recreation Through Community-Healthcare Engagement Study
| Status: | Recruiting |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 2 - 18 |
| Updated: | 11/8/2018 |
| Start Date: | June 7, 2018 |
| End Date: | December 2019 |
| Contact: | Sarah Armstrong, MD |
| Email: | sarah.c.armstrong@duke.edu |
| Phone: | 919-620-5374 |
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.
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.
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.
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.
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)
We found this trial at
6
sites
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