Clinical trial NCT03488212: Online Obesity Treatment in Primary Care (Rhode Island, USA)
Official title: Pragmatic Trial of Technology-Supported Behavioral Obesity Treatment in the Primary Care Setting: A Multiphase Effectiveness and Implementation Hybrid Design
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Overweight and Obesity
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2018-04-04
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Weight
timeFrame: 12 months after study enrollment
Secondary outcomes:
measure: Change in Weight
timeFrame: 24 months after study enrollment
measure: Proportion of Patients Achieving a Weight Loss of ≥5% of Initial Body Weight
timeFrame: 12 and 24 months after study enrollment
measure: Patient Satisfaction with the Treatment Program
timeFrame: 3 and 12 months after study enrollment
measure: Provider Satisfaction with the Treatment Program
timeFrame: 12 months after study enrollment
measure: Proportion of Patients Deemed Eligible by the Electronic Medical Record Who are Directed to the Online Treatment Program
timeFrame: 24 months after study initiation
measure: Proportion of Patients That Enroll After Being Directed to the Online Treatment Program
timeFrame: 24 months after study initiation
measure: Proportion of Enrolled Patients who Complete the Online Treatment Program
timeFrame: 24 months after study initiation
measure: Clinician Contact with Patients Directed to the Online Treatment Program
timeFrame: 24 months after study initiation
measure: Patient Engagement and Adherence to the Online Intervention.
timeFrame: 12 months after study enrollment
measure: Clinician Engagement with the Online Treatment Platform
timeFrame: 24 months after study initiation
measure: Change in Low-density Lipoprotein (mg/dL)
timeFrame: 12 and 24 months after study enrollment
measure: Change in High-density Lipoprotein (mg/dL)
timeFrame: 12 and 24 months after study enrollment
measure: Change in Triglycerides (mg/dL)
timeFrame: 12 and 24 months after study enrollment
measure: Change in Blood Glucose (mg/dL)
timeFrame: 12 and 24 months after study enrollment
measure: Change in Glycated Haemoglobin (HbA1c)
timeFrame: 12 and 24 months after study enrollment
measure: Change in Systolic Blood Pressure (mmHG)
timeFrame: 12 and 24 months after study enrollment
measure: Change in Diastolic Blood Pressure (mmHG)
timeFrame: 12 and 24 months after study enrollment
Other outcomes:
Locations:
city: Providence
country: United States
facility: Weight Control and Diabetes Resarch Center
state: Rhode Island
Study officials:
affiliation: The Miriam Hospital
name: Graham Thomas, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Miriam Hospital
name: Rena R Wing, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thomas JG, Panza E, Espel-Huynh HM, Goldstein CM, O'Leary K, Benedict N, Puerini AJ, Wing RR. Pragmatic implementation of a fully automated online obesity treatment in primary care. Obesity (Silver Spring). 2022 Aug;30(8):1621-1628. doi: 10.1002/oby.23502.