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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
840
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.
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.
Brigham and Women's Hospital
Boston, Massachusetts, United States
Change in Body Weight at 12 Months
change in body weight from enrollment to 12 months
Time frame: 12 months after the initial primary care visit
Change in Body Weight at 6 Months
change in body weight from enrollment to 6 months
Time frame: 6 months after the initial primary care visit
Change in Body Weight at 18 Months
change in body weight from enrollment to 18 months
Time frame: 18 months after the initial primary care visit
Percent Weight Change at 6 Months
Percent weight change from enrollment to 6 months
Time frame: 6 months after the initial primary care visit
Percent Weight Change at 12-Months
Percent weight change from enrollment to 12 months
Time frame: 12 months after the initial primary care visit
Percent Weight Change at 18-Months
Percent weight change from enrollment to 18 months
Time frame: 18 months after the initial primary care visit
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
Time frame: 6-months after the initial primary care visit
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
Time frame: 12 months after the initial primary care visit
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
Time frame: 18-months after the initial primary care visit
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.
Time frame: 12 months after initial primary care visit
Changes in Systolic Blood Pressure
changes in systolic blood pressure (BP) from enrollment to 12 months
Time frame: 12 months after the initial primary care visit
Changes in Diastolic Blood Pressure
changes in diastolic blood pressure (BP) from enrollment to 12 months
Time frame: 12 months after the initial primary care visit
Changes in Total Cholesterol
changes in total cholesterol from Enrollment to 12 Months
Time frame: 12 months after the initial primary care visit
Changes in HDL Cholesterol
changes in HDL cholesterol from Enrollment to 12 Months
Time frame: 12 months after the initial primary care visit
Changes in LDL Cholesterol
changes in LDL cholesterol from Enrollment to 12 Months
Time frame: 12 months after the initial primary care visit
Changes in Triglycerides
changes in triglycerides from enrollment to 12 months
Time frame: 12 months after the initial primary care visit
Changes in HbA1c Levels
changes in Hemoglobin (HbA1c) levels from enrollment to 12 months
Time frame: 12 months after the initial primary care visit
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).
Time frame: 12 months after the initial primary care visit
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).
Time frame: 12 months after the initial primary care visit
Changes in Self-reported Physical Activity
changes in self-reported physical activity minutes per week
Time frame: 12 months after the initial primary care visit
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.
Time frame: 12 months after the initial primary care visit
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.
Time frame: 12 months after the initial primary care visit
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.
Time frame: 12 months after the initial primary care visit
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.
Time frame: 12 months after the initial primary care visit
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.
Time frame: 12 months after the initial primary care visit
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.
Time frame: 12 months after the initial primary care visit
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.