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Integrating Online Weight Management With Primary Care Support (PROPS)

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ClinicalTrials.gov Identifier: NCT02656693
Recruitment Status : Completed
First Posted : January 15, 2016
Results First Posted : August 9, 2019
Last Update Posted : August 9, 2019
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Heather J. Baer, Brigham and Women's Hospital

Brief 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 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.

    b. 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.

  2. 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.

  3. 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.


Condition or disease Intervention/treatment Phase
Obesity Behavioral: Online weight management program Behavioral: Population health management support Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 840 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Integrating Online Weight Management With Primary Care Support: Patient-Centered Strategies for Addressing Overweight and Obesity in Primary Care
Actual Study Start Date : July 19, 2016
Actual Primary Completion Date : November 8, 2018
Actual Study Completion Date : May 8, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Online Program Only
Patients will use an online weight management program called BMIQ, with minimal additional support.
Behavioral: Online weight management program
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.

Experimental: Combined Intervention
Patients 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.
Behavioral: Online weight management program
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.

Behavioral: Population health management support
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.

No Intervention: Usual Care
Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)



Primary Outcome Measures :
  1. Change in Body Weight at 12 Months [ Time Frame: 12 months after the initial primary care visit ]
    change in body weight from enrollment to 12 months


Secondary Outcome Measures :
  1. Changes in Systolic Blood Pressure [ Time Frame: 12 months after the initial primary care visit ]
    changes in systolic blood pressure (BP) from enrollment to 12 months

  2. Changes in Diastolic Blood Pressure [ Time Frame: 12 months after the initial primary care visit ]
    changes in diastolic blood pressure (BP) from enrollment to 12 months

  3. Changes in Cholesterol [ Time Frame: 12 months after the initial primary care visit ]
    changes in total cholesterol from Enrollment to 12 Months

  4. Changes in Triglycerides [ Time Frame: 12 months after the initial primary care visit ]
    changes in triglycerides from enrollment to 12 months

  5. Changes in HbA1c Levels [ Time Frame: 12 months after the initial primary care visit ]
    changes in Hemoglobin (HbA1c) levels from enrollment to 12 months

  6. Changes in Weight-related Quality of Life Assessed by the Impact of Weight on Quality of Life (IWQOL)-Lite Questionnaire [ Time Frame: 12 months after the initial primary care visit ]
    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).

  7. Changes in Self-efficacy Around Weight Loss at 12 Months [ Time Frame: 12 months after initial primary care visit ]
    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.

  8. Changes in Diet, Specifically Fruits/Vegetables, as Measured by the PrimeScreen Questionnaire [ Time Frame: 12 months after the initial primary care visit ]
    changes in diet, specifically fruits/vegetables as measured by the PrimeScreen questionnaire, a brief dietary screening tool.

  9. Changes in Diet, Specifically Whole Grains, as Measured by the PrimeScreen Questionnaire [ Time Frame: 12 months after the initial primary care visit ]
    changes in diet, specifically whole grains as measured by the PrimeScreen questionnaire, a brief dietary screening tool.

  10. Changes in Self-reported Physical Activity [ Time Frame: 12 months after the initial primary care visit ]
    changes in self-reported physical activity minutes per week

  11. 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) [ Time Frame: 12 months after the initial primary care visit ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02656693


Locations
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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Heather Baer, ScD Brigham and Women's Hospital
  Study Documents (Full-Text)

Documents provided by Heather J. Baer, Brigham and Women's Hospital:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Heather J. Baer, Associate Epidemiologist, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02656693     History of Changes
Other Study ID Numbers: 2015P002372
First Posted: January 15, 2016    Key Record Dates
Results First Posted: August 9, 2019
Last Update Posted: August 9, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Heather J. Baer, Brigham and Women's Hospital:
Weight Reduction Programs
Weight Loss Programs
Obesity

Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms