Clinical trial NCT02656693: Integrating Online Weight Management With Primary Care Support
Official title: Integrating Online Weight Management With Primary Care Support: Patient-Centered Strategies for Addressing Overweight and Obesity in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Weight Reduction Programs
Weight Loss Programs
Obesity
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2016-01-15
Enrollment: 840
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in Body Weight at 12 Months
timeFrame: 12 months after the initial primary care visit
Secondary outcomes:
measure: Change in Body Weight at 6 Months
timeFrame: 6 months after the initial primary care visit
measure: Change in Body Weight at 18 Months
timeFrame: 18 months after the initial primary care visit
measure: Percent Weight Change at 6 Months
timeFrame: 6 months after the initial primary care visit
measure: Percent Weight Change at 12-Months
timeFrame: 12 months after the initial primary care visit
measure: Percent Weight Change at 18-Months
timeFrame: 18 months after the initial primary care visit
measure: Percent of Patients With at Least 5% Weight Loss at 6 Months
timeFrame: 6-months after the initial primary care visit
measure: Percent of Patients With at Least 5% Weight Loss at 12-months
timeFrame: 12 months after the initial primary care visit
measure: Percent of Patients With at Least 5% Weight Loss at 18 Months
timeFrame: 18-months after the initial primary care visit
measure: Changes in Self-efficacy Around Weight Loss at 12 Months
timeFrame: 12 months after initial primary care visit
measure: Changes in Systolic Blood Pressure
timeFrame: 12 months after the initial primary care visit
measure: Changes in Diastolic Blood Pressure
timeFrame: 12 months after the initial primary care visit
measure: Changes in Total Cholesterol
timeFrame: 12 months after the initial primary care visit
measure: Changes in HDL Cholesterol
timeFrame: 12 months after the initial primary care visit
measure: Changes in LDL Cholesterol
timeFrame: 12 months after the initial primary care visit
measure: Changes in Triglycerides
timeFrame: 12 months after the initial primary care visit
measure: Changes in HbA1c Levels
timeFrame: 12 months after the initial primary care visit
measure: Changes in Weight-related Quality of Life Assessed by the Impact of Weight on Quality of Life (IWQOL)-Lite Questionnaire
timeFrame: 12 months after the initial primary care visit
measure: 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)
timeFrame: 12 months after the initial primary care visit
measure: Changes in Self-reported Physical Activity
timeFrame: 12 months after the initial primary care visit
measure: Changes in Diet, Specifically Fruits/Vegetables, as Measured by the PrimeScreen Questionnaire
timeFrame: 12 months after the initial primary care visit
measure: Changes in Diet, Specifically Whole Grains, as Measured by the PrimeScreen Questionnaire
timeFrame: 12 months after the initial primary care visit
measure: Changes in Diet, Specifically Sugar-sweetened Beverages, as Measured by the PrimeScreen Questionnaire
timeFrame: 12 months after the initial primary care visit
measure: Changes in Diet, Specifically Baked Products, as Measured by the PrimeScreen Questionnaire
timeFrame: 12 months after the initial primary care visit
measure: Changes in Diet, Specifically Processed Meats, as Measured by the PrimeScreen Questionnaire
timeFrame: 12 months after the initial primary care visit
measure: Changes in Diet, Specifically Fried Foods, as Measured by the PrimeScreen Questionnaire
timeFrame: 12 months after the initial primary care visit
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Heather Baer, ScD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.