Integrating Online Weight Management With Primary Care Support
NCT ID: NCT02656693
Last Updated: 2020-11-05
Study Results
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View full resultsBasic Information
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COMPLETED
NA
840 participants
INTERVENTIONAL
2016-07-19
2019-05-08
Brief Summary
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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.
Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Online Program Only
Patients will use an online weight management program called BMIQ, with minimal additional support.
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.
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.
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.
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.
Usual Care
Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)
No interventions assigned to this group
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
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
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
20 Years
70 Years
ALL
No
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
Brigham and Women's Hospital
OTHER
Responsible Party
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Heather J. Baer
Associate Epidemiologist
Principal Investigators
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Heather Baer, ScD
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Locations
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Brigham and Women's Hospital
Boston, Massachusetts, United States
Countries
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References
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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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2015P002372
Identifier Type: -
Identifier Source: org_study_id