NCT03488212

Online Obesity Treatment in Primary Care (Rhode Island, USA)

Pragmatic Trial of Technology-Supported Behavioral Obesity Treatment in the Primary Care Setting: A Multiphase Effectiveness and Implementation Hybrid Design

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: The Miriam Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Behavioral obesity treatment produces clinically significant weight loss; for the greatest impact, it should be made available in the primary care setting where it can reach the many patients with overweight/obesity. The investigators developed a 3-month automated online behavioral weight loss program, Rx Weight Loss (RxWL), and showed that it produces clinically significant weight losses among primary care patients. The investigators' early efforts at pragmatic implementation of RxWL have been promising, and have shed light on challenges associated with implementation, and the need to study longer-term effectiveness. The investigators will therefore conduct a pragmatic study to improve the implementation and effectiveness of this behavioral obesity intervention delivered in routine and representative healthcare settings. The investigators are partnering with the Rhode Island Primary Care Physicians Corporation (RIPCPC), a large primary care network of 58 practices with 100 physicians and 16 nurse care managers. Using the framework for Effectiveness-Implementation Hybrid Designs, the investigators will simultaneously target effectiveness and implementation to maximize the public health impact of the research. Half of the 16 nurse care managers, and the practices they serve, will be randomized to either Basic Implementation (alerts generated using the electronic medical record \[EMR\] to direct eligible patients to RxWL), or to the Enhanced Implementation (alerts, clinician skills training to motivate and support weight loss, clinician dashboard with reports on patient progress and tools to facilitate patient engagement and behavior change). The investigators will test the hypothesis that the Enhanced Implementation will increase the proportion of patients directed to, enrolling, and completing the weight loss program. Because maintenance of weight loss is a critical problem, this project will also involve randomization of 600 patients with overweight/obesity and type 2 diabetes, hypertension, and/or hypercholesterolemia to the 3 month RxWL intervention followed by one of three maintenance conditions: (a) Control- 9 monthly online education sessions; (b) Monthly Lessons and Feedback- 9 monthly online video lessons teaching self-regulation with automated feedback on the self-monitoring record; (c) Refresher Campaigns- 9 monthly on-line video sessions, teaching self-regulation and providing two 4-week courses with novel strategies and behavioral challenges to improve long-term outcomes. The investigators will test the hypothesis that 12-month weight losses are better with Refresher Campaigns than Monthly Lessons and Feedback, and both are better than Control. Secondary outcomes include changes in weight, CVD risk factors, and medication use over a full 24 months. The project is significant and innovative because: it uses an empirically validated approach to obesity treatment that is integrated into the primary care setting, leveraging existing staff and EMR capabilities; it has a dual focus on improving effectiveness and implementation; it has a pragmatic design in partnership with a large primary care network that treats a diverse patient population; and it has potential to it provides a scalable, sustainable approach that can serve as a model for broader dissemination of obesity treatment intervention.

Conditions

• Overweight and Obesity

Interventions

Type	Name	Description
BEHAVIORAL	Training to Identify Eligible Patients and Direct them to Online Obesity Treatment Program	Primary care clinic staff are trained to identify patients who meet study inclusion and exclusion criteria. They are then trained to provide patients with the information necessary to enroll in the study and access the online behavioral obesity treatment.
BEHAVIORAL	Training to Motivate and Support Patients' Weight Loss	Primary care clinic staff are trained in psychological and behavioral strategies for: talking to patients about weight and weight loss in a way that patients find acceptable and helpful, increasing motivation for weight loss, overcoming common barriers to weight loss, and persevering with a weight loss attempt. They are trained in strategies to provide this support by telephone in addition to during clinic visits.
BEHAVIORAL	Online Behavioral Weight Loss Intervention	For 3 months, participants receive: a weekly online lessons for training in behavioral skills for losing weight; online self-monitoring of daily weight, diet, and physical activity; weekly feedback on the self-monitoring record.
BEHAVIORAL	Control Intervention for Weight Loss Maintenance and Weight Gain Prevention	After completing the 3-month Online Behavioral Weight Loss Intervention, participants receive 9 months of: monthly online newsletters with educational information pertaining to healthy weight, diet, and physical activity habits.
BEHAVIORAL	Monthly Lessons and Feedback Intervention for Weight Loss Maintenance and Weight Gain Prevention	After completing the 3-month Online Behavioral Weight Loss Intervention, participants receive 9 months of: monthly online lessons for training in behavioral skills for maintaining weight loss and preventing weight gain; online self-monitoring of daily weight, diet, and physical activity; monthly feedback on the self-monitoring record.
BEHAVIORAL	Refresher Courses for Weight Loss Maintenance and Weight Gain Prevention	After completing the 3-month Online Behavioral Weight Loss Intervention, participants receive two month-long refresher courses with weekly online lessons for training in behavioral skills for maintaining weight loss and preventing weight gain; online self-monitoring of daily weight, diet, and physical activity; weekly feedback on the self-monitoring record; weekly challenges focuses on specific behavior change and weight loss goals.

Timeline

• Start date: 2018-05-31
• Primary completion: 2021-04-30
• Completion: 2021-04-30
• First posted: 2018-04-04
• Last updated: 2020-02-20

Locations

1 site across 1 country: United States