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Overweight and ObesityNCT03488212

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

A study testing Training to Identify Eligible Patients and Direct them to Online Obesity Treatment Program, Training to Motivate and Support Patients' Weight Loss and Online Behavioral Weight Loss Intervention in people with Overweight and Obesity, run by The Miriam Hospital at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Overweight and Obesity
What is being tested?
Training to Identify Eligible Patients and Direct them to Online Obesity Treatment Program, Training to Motivate and Support Patients' Weight Loss and Online Behavioral Weight Loss Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
1 siteUnited States
Study dates
31 May 2018to 30 Apr 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Weight Control and Diabetes Resarch Center

    Providence, Rhode Island, 02903

Other trials in United States

About this study

Official title: 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.

Being tested
Training to Identify Eligible Patients and Direct them to Online Obesity Treatment Program, Training to Motivate and Support Patients' Weight Loss, Online Behavioral Weight Loss Intervention, Control Intervention for Weight Loss Maintenance and Weight Gain Prevention, Monthly Lessons and Feedback Intervention for Weight Loss Maintenance and Weight Gain Prevention
Medical subject headings
Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Training to Identify Eligible Patients and Direct them to Online Obesity Treatment ProgramBehavioural

    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.

  • Training to Motivate and Support Patients' Weight LossBehavioural

    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.

  • Online Behavioral Weight Loss InterventionBehavioural

    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.

  • Control Intervention for Weight Loss Maintenance and Weight Gain PreventionBehavioural

    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.

  • Monthly Lessons and Feedback Intervention for Weight Loss Maintenance and Weight Gain PreventionBehavioural

    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.

  • Refresher Courses for Weight Loss Maintenance and Weight Gain PreventionBehavioural

    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.

Study groups in NCT03488212
Study groupRoleWhat they receive
Basic Implementation InterventionActive comparatorNot described
Receives: Behavioral: Training to Identify Eligible Patients and Direct them to Online Obesity Treatment Program
Enhanced Implementation InterventionExperimentalNot described
Receives: Behavioral: Training to Identify Eligible Patients and Direct them to Online Obesity Treatment Program; Behavioral: Training to Motivate and Support Patients' Weight Loss
Online Treatment; Control Maintenance InterventionActive comparatorNot described
Receives: Behavioral: Online Behavioral Weight Loss Intervention; Behavioral: Control Intervention for Weight Loss Maintenance and Weight Gain Prevention
Online Treatment; Monthly Lessons & Feedback for MaintenanceExperimentalNot described
Receives: Behavioral: Online Behavioral Weight Loss Intervention; Behavioral: Monthly Lessons and Feedback Intervention for Weight Loss Maintenance and Weight Gain Prevention
Online Treatment; Refresher Courses for MaintenanceExperimentalNot described
Receives: Behavioral: Online Behavioral Weight Loss Intervention; Behavioral: Refresher Courses for Weight Loss Maintenance and Weight Gain Prevention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Weight

    Measured: 12 months after study enrollment

Secondary outcomes (17)

  1. Change in Weight

    Measured: 24 months after study enrollment

  2. Proportion of Patients Achieving a Weight Loss of ≥5% of Initial Body Weight

    Measured: 12 and 24 months after study enrollment

  3. Patient Satisfaction with the Treatment Program

    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).

    Measured: 3 and 12 months after study enrollment

  4. Provider Satisfaction with the Treatment Program

    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).

    Measured: 12 months after study enrollment

  5. Proportion of Patients Deemed Eligible by the Electronic Medical Record Who are Directed to the Online Treatment Program

    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.

    Measured: 24 months after study initiation

  6. Proportion of Patients That Enroll After Being Directed to the Online Treatment Program

    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.

    Measured: 24 months after study initiation

  7. Proportion of Enrolled Patients who Complete the Online Treatment Program

    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.

    Measured: 24 months after study initiation

  8. Clinician Contact with Patients Directed to the Online Treatment Program

    Number and type of clinician contact with patients (e.g., clinic visits, phone calls).

    Measured: 24 months after study initiation

  9. Patient Engagement and Adherence to the Online Intervention.

    The online treatment platform automatically records all aspects of use including logins, lessons viewed, and self-monitoring records submitted.

    Measured: 12 months after study enrollment

  10. Clinician Engagement with the Online Treatment Platform

    Frequency and type of use (e.g., viewing patients progress metrics) of the online platform for tracking patient progress in the online treatment.

    Measured: 24 months after study initiation

  11. Change in Low-density Lipoprotein (mg/dL)

    Measured: 12 and 24 months after study enrollment

  12. Change in High-density Lipoprotein (mg/dL)

    Measured: 12 and 24 months after study enrollment

  13. Change in Triglycerides (mg/dL)

    Measured: 12 and 24 months after study enrollment

  14. Change in Blood Glucose (mg/dL)

    Measured: 12 and 24 months after study enrollment

  15. Change in Glycated Haemoglobin (HbA1c)

    Measured: 12 and 24 months after study enrollment

  16. Change in Systolic Blood Pressure (mmHG)

    Measured: 12 and 24 months after study enrollment

  17. Change in Diastolic Blood Pressure (mmHG)

    Measured: 12 and 24 months after study enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2018
  2. Study start31 May 2018
  3. Primary completion30 Apr 2021 (estimated)
  4. Study completion30 Apr 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03488212
Sponsor's protocol ID
R18DK114715
Other IDs
R18DK114715
Status last verified
Feb 2020
First submitted
22 Mar 2018
Last updated
20 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Goldstein CM, Panza E, Hayes JF, Thomas JG, O'Leary K, Wing RR. Pragmatic online obesity treatment in primary care: a hybrid randomized clinical trial of implementation strategies. NPJ Cardiovasc Health. 2024 Nov 6;1(1):29. doi: 10.1038/s44325-024-00030-w.

    PubMed 41775991

  • Thomas JG, Panza E, Goldstein CM, Hayes JF, Benedict N, O'Leary K, Wing RR. Pragmatic Implementation of Online Obesity Treatment and Maintenance Interventions in Primary Care: A Randomized Clinical Trial. JAMA Intern Med. 2024 May 1;184(5):502-509. doi: 10.1001/jamainternmed.2023.8438.

    PubMed 38466266

  • 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.

    PubMed 35894075

Questions about this trial

What is this clinical trial studying?

A study testing Training to Identify Eligible Patients and Direct them to Online Obesity Treatment Program, Training to Motivate and Support Patients' Weight Loss and Online Behavioral Weight Loss Intervention in people with Overweight and Obesity, run by The Miriam Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Weight (time frame: 12 months after study enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03488212, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2020.

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