AzTrials
AzTrials

ObesityPROPSNCT02656693

Integrating Online Weight Management With Primary Care Support

A study testing Online weight management program and Population health management support in people with Obesity, run by Brigham and Women's Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The goal of this project is to adapt an evidence-based online weight management program and integrate it with population management support from primary care practices. Investigators then will conduct a three-arm, cluster-randomized trial to compare the effectiveness of 1) the combined intervention (online weight… Read more about this study

Who is it for?
Ages 20 to 70 years
Conditions the study is for
Obesity
What is being tested?
Online weight management program and Population health management support
Could I receive a placebo?
No, everyone receives an active treatment
How many people
840 participants
Where
1 siteUnited States
Study dates
19 Jul 2016to 8 May 2019
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

  • upcoming or recent visit at primary care practice affiliated with Brigham and Women's Hospital
  • age 20-70
  • diagnosis of type 2 diabetes and/or hypertension
  • BMI >= 27 and < 40 kg/m2
  • motivated to lose weight
  • valid email address and access the Internet using a computer, tablet, or smartphone
  • English or Spanish-speaking

Who cannot join

  • 1. on insulin for treatment of their diabetes 2. MI, stroke, or atherosclerotic cardiovascular disease (ASCVD) procedure in last 6 months 3. Unstable angina 4. Currently pregnant or planning to become pregnant during the study period 5. Currently lactating 5. Has had bariatric surgery or planning to have bariatric surgery 6. >5% weight loss in the last 6 months 7. Severe psychiatric illness or impaired mental status 8. Active or diagnosed history of and/or self-reported history of eating disorders 9. Self-reported average consumption of > 14 alcoholic drinks/week 10. Any serious medical condition that would affect weight loss or for which weight loss is contraindicated, including active cancer (excluding non-melanoma skin cancer) or currently being treated for cancer, end stage renal disease (ESRD) on dialysis, etc.
  • 11. On comfort care measures, hospice, or in nursing home 12. Participating in a contra-indicative research study 13. Use of prescription or over-the-counter weight loss medications or an all-liquid diet program in the last 6 months or currently 14. Any other medical contraindication for weight loss or physical activity, or any other reason that the PCP or their delegate (e.g., LPN or RN) did not deem the patient appropriate for the study

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

Other trials in United States

About this study

Official title: Integrating Online Weight Management With Primary Care Support: Patient-Centered Strategies for Addressing Overweight and Obesity in Primary Care

The goal of this project is to adapt an evidence-based online weight management program and integrate it with population management support from primary care practices. Investigators then will conduct a three-arm, cluster-randomized trial to compare the effectiveness of 1) the combined intervention (online weight management program plus population management support) with 2) the stand-alone online weight management program and with 3) usual care, among overweight and obese primary care patients with type 2 diabetes or hypertension. The specific aims are:

  1. a. To adapt an online weight management program and integrate it with population management support, incorporating input from patients, primary care clinicians, and other stakeholders; afterward, investigators will acquire feedback on the positive and negative aspects of the intervention.
  2. To compare the effectiveness of the combined intervention (online weight management program plus population management support) with the stand-alone online program and with usual care. Hypothesis 1: The combined intervention will lead to greater weight loss at 12 months compared with the stand-alone online program and with usual care.
  3. To identify mediators of the combined intervention and the stand-alone online program. Hypothesis 2: The effects of the combined intervention and the stand-alone online program on weight loss will be mediated by patients' level of engagement, changes in self-efficacy, and changes in diet and physical activity.
  4. To explore whether the effectiveness of the combined intervention and the stand-alone weight management program varies by patient characteristics.

Hypothesis 3: The interventions will be more effective among patients who are younger, white, and higher socioeconomic status, although the population management strategy may help to reduce these differences.

Read the detailed description

Focus Groups and Key Informant Interviews:

Focus groups will be conducted with 5 to 7 patients at the beginning of the study to obtain their feedback about an online program and the population health management support strategy. To be eligible for the focus groups, patients must have a Brigham and Women's Hospital (BWH) primary care clinician, be between ages 20-70 years old, and have a recent BMI (in the past year) between approximately 27 and 40 kg/m2. They should also be interested in weight management and/or motivated to lose weight.

Phone interviews will be conducted at the end of the study to solicit feedback on the BMIQ program and the population health management intervention. Patients in the PROPS Study who are assigned to the online program or combined intervention arm, reach the 18-month timepoint, and complete the final study survey are eligible and will be invited to participate.

Key Informant Interviews will be conducted at the beginning and the end of the study. To be eligible, the key informants must be clinicians or other staff who provide services to patients at one of the participating BWH primary care practices. There are a total of 165 clinicians in these practices, including staff physicians, residents or fellows, and nurse practitioners or physician assistants. Approximately 7 clinicians at each timepoint will be recruited as key informants and will also be asked to complete electronic surveys during the trial.

After adapting the online weight management program and integrating it with the population management support strategy based on our focus groups and key informant interviews, investigators will conduct a three-arm cluster-randomized trial to compare the effectiveness of the combined intervention (online weight management program plus population management support) with the stand-alone online weight management program and with usual care. This will be a pragmatic clinical trial conducted in approximately 14 BWH primary care practices. To be eligible for the trial, patients must have an upcoming scheduled visit at a BWH primary care practice, BMI between 27 and 39.9 kg/m2 at enrollment, and a diagnosis of type 2 diabetes or hypertension. They also must be between ages 20 and 70 (inclusive) at enrollment, speak English or Spanish, and have access the Internet using a computer, tablet, or smart phone. Finally, patients must be motivated to lose weight. Investigators plan to recruit a total of 840 patients for the study (280 per arm). Patients who enroll in the trial will attend regular primary care visits at their practices and also will complete surveys by e-mail, regular mail, or phone.

Conditions
Obesity
Being tested
Online weight management program, Population health management support
Keywords
Weight Reduction Programs, Weight Loss Programs, Obesity
Medical subject headings
Obesity

What participants receive

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

  • Online weight management programBehavioural

    Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program.

  • Population health management supportBehavioural

    Patients will receive weight-related population health management support from their primary care practice; their online weight management program data will be monitored by the population health manager, who will conduct outreach with patients at designated points according to the protocol.

Study groups in NCT02656693
Study groupRoleWhat they receive
Online Program OnlyExperimentalPatients will use an online weight management program called BMIQ, with minimal additional support.
Receives: Behavioral: Online weight management program
Combined InterventionExperimentalPatients will use an online weight management program called BMIQ, but will also receive additional monitoring and support from a population health manager who works with their primary care practices.
Receives: Behavioral: Online weight management program; Behavioral: Population health management support
Usual CareNo interventionPatients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)

What is being measured

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

  1. Change in Body Weight at 12 Months

    change in body weight from enrollment to 12 months

    Measured: 12 months after the initial primary care visit

Secondary outcomes (25)

  1. Change in Body Weight at 6 Months

    change in body weight from enrollment to 6 months

    Measured: 6 months after the initial primary care visit

  2. Change in Body Weight at 18 Months

    change in body weight from enrollment to 18 months

    Measured: 18 months after the initial primary care visit

  3. Percent Weight Change at 6 Months

    Percent weight change from enrollment to 6 months

    Measured: 6 months after the initial primary care visit

  4. Percent Weight Change at 12-Months

    Percent weight change from enrollment to 12 months

    Measured: 12 months after the initial primary care visit

  5. Percent Weight Change at 18-Months

    Percent weight change from enrollment to 18 months

    Measured: 18 months after the initial primary care visit

  6. Percent of Patients With at Least 5% Weight Loss at 6 Months

    Percent of Patients With at Least 5% Weight Loss from enrollment to 6 months

    Measured: 6-months after the initial primary care visit

  7. Percent of Patients With at Least 5% Weight Loss at 12-months

    Percent of Patients with at least 5% weight loss from enrollment to 12 months

    Measured: 12 months after the initial primary care visit

  8. Percent of Patients With at Least 5% Weight Loss at 18 Months

    Percent of Patients With at least 5% weight loss from enrollment to 18 months

    Measured: 18-months after the initial primary care visit

  9. Changes in Self-efficacy Around Weight Loss at 12 Months

    Changes in self-efficacy around weight loss at 12 months Self-efficacy will be assessed by asking patients to rate their confidence in their ability to lose weight on a scale from 1 ("not at all confident") to 10 ("very confident"). A rank of 1-7 reflects low self-efficacy, while 8-10 reflects high self-efficacy based on Bandura's theory of self-efficacy.

    Measured: 12 months after initial primary care visit

  10. Changes in Systolic Blood Pressure

    changes in systolic blood pressure (BP) from enrollment to 12 months

    Measured: 12 months after the initial primary care visit

  11. Changes in Diastolic Blood Pressure

    changes in diastolic blood pressure (BP) from enrollment to 12 months

    Measured: 12 months after the initial primary care visit

  12. Changes in Total Cholesterol

    changes in total cholesterol from Enrollment to 12 Months

    Measured: 12 months after the initial primary care visit

  13. Changes in HDL Cholesterol

    changes in HDL cholesterol from Enrollment to 12 Months

    Measured: 12 months after the initial primary care visit

  14. Changes in LDL Cholesterol

    changes in LDL cholesterol from Enrollment to 12 Months

    Measured: 12 months after the initial primary care visit

  15. Changes in Triglycerides

    changes in triglycerides from enrollment to 12 months

    Measured: 12 months after the initial primary care visit

  16. Changes in HbA1c Levels

    changes in Hemoglobin (HbA1c) levels from enrollment to 12 months

    Measured: 12 months after the initial primary care visit

  17. Changes in Weight-related Quality of Life Assessed by the Impact of Weight on Quality of Life (IWQOL)-Lite Questionnaire

    Weight-related quality of life will be assessed using the Impact of Weight of Quality of Life (IWQOL)-Lite questionnare. The IWQOL-Lite is a brief, 31-item self-report measure that consists of scores on five scales (physical function, self-esteem, sexual life, public distress, and work) and a total score (sum of scale scores). Participants are asked to rate items with respect to the past week, with responses from "never true" to "always true". Total scores range from 0 (worst possible quality of life) to 100 (best possible quality of life).

    Measured: 12 months after the initial primary care visit

  18. Changes in Percentage of Patients Reporting Excellent/Very Good Health Status Assessed by Using a 5-point Scale Questionnaire From the 36-Item Short Form Health Survey(SF-36)

    Health status will be assessed using 5-point scale response to a single question from the SF-36, "In general, would you say that your health is...(1=Excellent, 2=Very Good, 3=Good, 4=Fair, 5=Poor"). A higher score indicates a worse outcome (5= poor health status).

    Measured: 12 months after the initial primary care visit

  19. Changes in Self-reported Physical Activity

    changes in self-reported physical activity minutes per week

    Measured: 12 months after the initial primary care visit

  20. Changes in Diet, Specifically Fruits/Vegetables, as Measured by the PrimeScreen Questionnaire

    changes in diet, specifically fruits/vegetables as measured by the PrimeScreen questionnaire, a brief dietary screening tool.

    Measured: 12 months after the initial primary care visit

  21. Changes in Diet, Specifically Whole Grains, as Measured by the PrimeScreen Questionnaire

    changes in diet, specifically whole grains as measured by the PrimeScreen questionnaire, a brief dietary screening tool.

    Measured: 12 months after the initial primary care visit

  22. Changes in Diet, Specifically Sugar-sweetened Beverages, as Measured by the PrimeScreen Questionnaire

    changes in diet, specifically sugar-sweetened beverages as measured by the PrimeScreen questionnaire, a brief dietary screening tool.

    Measured: 12 months after the initial primary care visit

  23. Changes in Diet, Specifically Baked Products, as Measured by the PrimeScreen Questionnaire

    changes in diet, specifically baked products as measured by the PrimeScreen questionnaire, a brief dietary screening tool.

    Measured: 12 months after the initial primary care visit

  24. Changes in Diet, Specifically Processed Meats, as Measured by the PrimeScreen Questionnaire

    changes in diet, specifically processed meats as measured by the PrimeScreen questionnaire, a brief dietary screening tool.

    Measured: 12 months after the initial primary care visit

  25. Changes in Diet, Specifically Fried Foods, as Measured by the PrimeScreen Questionnaire

    changes in diet, specifically fried foods as measured by the PrimeScreen questionnaire, a brief dietary screening tool.

    Measured: 12 months after the initial primary care visit

Timeline

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

  1. First posted15 Jan 2016 (estimated)
  2. Study start19 Jul 2016
  3. Primary completion8 Nov 2018
  4. Study completion8 May 2019

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
840 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02656693
Sponsor's protocol ID
2015P002372
Acronym
PROPS
Status last verified
Oct 2020
First submitted
4 Jan 2016
Last updated
5 Nov 2020
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Baer HJ, Rozenblum R, De La Cruz BA, Orav EJ, Wien M, Nolido NV, Metzler K, McManus KD, Halperin F, Aronne LJ, Minero G, Block JP, Bates DW. Effect of an Online Weight Management Program Integrated With Population Health Management on Weight Change: A Randomized Clinical Trial. JAMA. 2020 Nov 3;324(17):1737-1746. doi: 10.1001/jama.2020.18977.

    PubMed 33141209

  • Baer HJ, De La Cruz BA, Rozenblum R, Nolido NV, Orav EJ, Metzler K, Block JP, Halperin F, McManus KD, Aronne LJ, Minero G, Bates DW. Integrating an online weight management program with population health management in primary care: Design, methods, and baseline data from the PROPS randomized controlled trial (Partnerships for Reducing Overweight and Obesity with Patient-centered Strategies). Contemp Clin Trials. 2020 Aug;95:106026. doi: 10.1016/j.cct.2020.106026. Epub 2020 May 16.

    PubMed 32428586

  • Rozenblum R, De La Cruz BA, Nolido NV, Adighibe I, Secinaro K, McManus KD, Halperin F, Block JP, Bates DW, Baer HJ. Primary Care Patients' and Providers' Perspectives about an Online Weight Management Program: a Qualitative Study. J Gen Intern Med. 2019 Aug;34(8):1503-1521. doi: 10.1007/s11606-019-05022-6. Epub 2019 May 31.

    PubMed 31152361

Questions about this trial

What is this clinical trial studying?

A study testing Online weight management program and Population health management support in people with Obesity, run by Brigham and Women's 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 7 inclusion and 2 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: finished, as of the sponsor's last update on 5 Nov 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?

Yes. Results are posted in the registry (first posted 9 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Body Weight at 12 Months (time frame: 12 months after the initial primary care visit). 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 NCT02656693, 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 5 Nov 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in