- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03488212
Online Obesity Treatment in Primary Care (Rhode Island, USA)
February 18, 2020 updated by: John Graham Thomas, The Miriam Hospital
Pragmatic Trial of Technology-Supported Behavioral Obesity Treatment in the Primary Care Setting: A Multiphase Effectiveness and Implementation Hybrid Design
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
- Behavioral: Training to Identify Eligible Patients and Direct them to Online Obesity Treatment Program
- Behavioral: Training to Motivate and Support Patients' Weight Loss
- Behavioral: Online Behavioral Weight Loss Intervention
- Behavioral: Control Intervention for Weight Loss Maintenance and Weight Gain Prevention
- Behavioral: Monthly Lessons and Feedback Intervention for Weight Loss Maintenance and Weight Gain Prevention
- Behavioral: Refresher Courses for Weight Loss Maintenance and Weight Gain Prevention
Study Type
Interventional
Enrollment (Anticipated)
600
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rhode Island
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Providence, Rhode Island, United States, 02903
- Weight Control and Diabetes Resarch Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Basic Implementation Intervention
|
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.
|
Experimental: Enhanced Implementation Intervention
|
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.
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.
|
Active Comparator: Online Treatment; Control Maintenance 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.
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.
|
Experimental: Online Treatment; Monthly Lessons & Feedback for Maintenance
|
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.
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.
|
Experimental: Online Treatment; Refresher Courses for Maintenance
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Weight
Time Frame: 12 months after study enrollment
|
12 months after study enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Weight
Time Frame: 24 months after study enrollment
|
24 months after study enrollment
|
|
Proportion of Patients Achieving a Weight Loss of ≥5% of Initial Body Weight
Time Frame: 12 and 24 months after study enrollment
|
12 and 24 months after study enrollment
|
|
Patient Satisfaction with the Treatment Program
Time Frame: 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).
|
3 and 12 months after study enrollment
|
Provider Satisfaction with the Treatment Program
Time Frame: 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).
|
12 months after study enrollment
|
Proportion of Patients Deemed Eligible by the Electronic Medical Record Who are Directed to the Online Treatment Program
Time Frame: 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.
|
24 months after study initiation
|
Proportion of Patients That Enroll After Being Directed to the Online Treatment Program
Time Frame: 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.
|
24 months after study initiation
|
Proportion of Enrolled Patients who Complete the Online Treatment Program
Time Frame: 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.
|
24 months after study initiation
|
Clinician Contact with Patients Directed to the Online Treatment Program
Time Frame: 24 months after study initiation
|
Number and type of clinician contact with patients (e.g., clinic visits, phone calls).
|
24 months after study initiation
|
Patient Engagement and Adherence to the Online Intervention.
Time Frame: 12 months after study enrollment
|
The online treatment platform automatically records all aspects of use including logins, lessons viewed, and self-monitoring records submitted.
|
12 months after study enrollment
|
Clinician Engagement with the Online Treatment Platform
Time Frame: 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.
|
24 months after study initiation
|
Change in Low-density Lipoprotein (mg/dL)
Time Frame: 12 and 24 months after study enrollment
|
12 and 24 months after study enrollment
|
|
Change in High-density Lipoprotein (mg/dL)
Time Frame: 12 and 24 months after study enrollment
|
12 and 24 months after study enrollment
|
|
Change in Triglycerides (mg/dL)
Time Frame: 12 and 24 months after study enrollment
|
12 and 24 months after study enrollment
|
|
Change in Blood Glucose (mg/dL)
Time Frame: 12 and 24 months after study enrollment
|
12 and 24 months after study enrollment
|
|
Change in Glycated Haemoglobin (HbA1c)
Time Frame: 12 and 24 months after study enrollment
|
12 and 24 months after study enrollment
|
|
Change in Systolic Blood Pressure (mmHG)
Time Frame: 12 and 24 months after study enrollment
|
12 and 24 months after study enrollment
|
|
Change in Diastolic Blood Pressure (mmHG)
Time Frame: 12 and 24 months after study enrollment
|
12 and 24 months after study enrollment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Graham Thomas, PhD, The Miriam Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 31, 2018
Primary Completion (Anticipated)
April 30, 2021
Study Completion (Anticipated)
April 30, 2021
Study Registration Dates
First Submitted
March 22, 2018
First Submitted That Met QC Criteria
March 28, 2018
First Posted (Actual)
April 4, 2018
Study Record Updates
Last Update Posted (Actual)
February 20, 2020
Last Update Submitted That Met QC Criteria
February 18, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R18DK114715 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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