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

Not Applicable

• Conditions: Overweight and Obesity

• Registration Number: NCT03488212
• Lead Sponsor: The Miriam Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-22
• Study First Submitted QC: 2018-03-28
• Study First Posted: 2018-04-04
• Study Start: 2018-05-31
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-18
• Last Update Posted: 2020-02-20
• Primary Completion: 2021-04-30
• Study Completion: 2021-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• Body mass index (BMI) between 25-45 kg/meters-squared
• one or more cardiovascular risk factor (type 2 diabetes, hypercholesterolemia, or hypertension)

Exclusion Criteria

• currently in another active weight loss program
• taking weight loss medication
• currently pregnant, lactating
• <6 months post-partum
• plan to become pregnant during the next 12 months
• a medical condition that would affect the safety of participating in unsupervised physical activity
• inability to walk 2 blocks without stopping

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Weight	12 months after study enrollment

Secondary Outcome Measures

Name	Time	Method
Proportion of Patients Achieving a Weight Loss of ≥5% of Initial Body Weight	12 and 24 months after study enrollment
Change in Low-density Lipoprotein (mg/dL)	12 and 24 months after study enrollment
Change in Weight	24 months after study enrollment
Provider Satisfaction with the Treatment Program	12 months after study enrollment	Using a questionnaire developed for this study, providers are asked to rate their overall satisfaction with the treatment program, and specific components of the treatment program, on a 5-point Likert scale ranging from 1 (Low) to 5 (High).
Proportion of Patients Deemed Eligible by the Electronic Medical Record Who are Directed to the Online Treatment Program	24 months after study initiation	The proportion of patients who approached by clinic staff for potential participation in the study, out of the patients who are deemed potentially eligible in reports generated using the electronic medical record.
Proportion of Enrolled Patients who Complete the Online Treatment Program	24 months after study initiation	The proportion of patients who complete the initial 3-month weight loss treatment and following 9-month weight loss maintenance and weight gain prevention program, out of those that enroll.
Patient Satisfaction with the Treatment Program	3 and 12 months after study enrollment	Using a questionnaire developed for this study, patients are asked to rate their overall satisfaction with the treatment program, specific components of the treatment program, and the likelihood that they would recommend the program to family and friends, on a 5-point Likert scale ranging from 1 (Low) to 5 (High).
Clinician Contact with Patients Directed to the Online Treatment Program	24 months after study initiation	Number and type of clinician contact with patients (e.g., clinic visits, phone calls).
Patient Engagement and Adherence to the Online Intervention.	12 months after study enrollment	The online treatment platform automatically records all aspects of use including logins, lessons viewed, and self-monitoring records submitted.
Proportion of Patients That Enroll After Being Directed to the Online Treatment Program	24 months after study initiation	The proportion of patients who enroll in the study out of the patients who are approached by clinic staff for potential participation in the study.
Clinician Engagement with the Online Treatment Platform	24 months after study initiation	Frequency and type of use (e.g., viewing patients progress metrics) of the online platform for tracking patient progress in the online treatment.
Change in High-density Lipoprotein (mg/dL)	12 and 24 months after study enrollment
Change in Triglycerides (mg/dL)	12 and 24 months after study enrollment
Change in Systolic Blood Pressure (mmHG)	12 and 24 months after study enrollment
Change in Blood Glucose (mg/dL)	12 and 24 months after study enrollment
Change in Glycated Haemoglobin (HbA1c)	12 and 24 months after study enrollment
Change in Diastolic Blood Pressure (mmHG)	12 and 24 months after study enrollment

Trial Locations

Locations (1)

Weight Control and Diabetes Resarch Center; 🇺🇸 Providence, Rhode Island, United States