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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Weight Control and Diabetes Resarch Center

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Basic Implementation Intervention
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.
Experimental: Enhanced Implementation Intervention
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.
Active Comparator: Online Treatment; Control Maintenance Intervention
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.
Experimental: Online Treatment; Monthly Lessons & Feedback for Maintenance
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: 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.
Experimental: Online Treatment; Refresher Courses for Maintenance
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: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in Weight
Time Frame: 12 months after study enrollment
12 months after study enrollment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Miriam Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 31, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 22, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 20, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on Overweight and Obesity

Clinical Trials on Training to Identify Eligible Patients and Direct them to Online Obesity Treatment Program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings