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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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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:
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.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Online Program Only | Experimental | Patients will use an online weight management program called BMIQ, with minimal additional support. |
|
| Combined Intervention | Experimental | 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. |
|
| Usual Care | No Intervention | Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Online weight management program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Weight at 12 Months | change in body weight from enrollment to 12 months | 12 months after the initial primary care visit |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Weight at 6 Months | change in body weight from enrollment to 6 months | 6 months after the initial primary care visit |
| Change in Body Weight at 18 Months | change in body weight from enrollment to 18 months |
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Inclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Heather Baer, ScD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33141209 | Derived | 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. | |
| 32428586 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.) |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.) |
| BG001 | Online Program Only |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Body Weight at 12 Months | change in body weight from enrollment to 12 months | Posted | Mean | 95% Confidence Interval | kilograms | 12 months after the initial primary care visit |
|
Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study.
Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care | Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Heather J. Baer, ScD | Brigham and Women's Hospital | 617-525-7503 | hbaer@bwh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 11, 2019 | Jun 24, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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|
| Population health management support | Behavioral | 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. |
|
| 18 months after the initial primary care visit |
| Percent Weight Change at 6 Months | Percent weight change from enrollment to 6 months | 6 months after the initial primary care visit |
| Percent Weight Change at 12-Months | Percent weight change from enrollment to 12 months | 12 months after the initial primary care visit |
| Percent Weight Change at 18-Months | Percent weight change from enrollment to 18 months | 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 | 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 | 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 | 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. | 12 months after initial primary care visit |
| Changes in Systolic Blood Pressure | changes in systolic blood pressure (BP) from enrollment to 12 months | 12 months after the initial primary care visit |
| Changes in Diastolic Blood Pressure | changes in diastolic blood pressure (BP) from enrollment to 12 months | 12 months after the initial primary care visit |
| Changes in Total Cholesterol | changes in total cholesterol from Enrollment to 12 Months | 12 months after the initial primary care visit |
| Changes in HDL Cholesterol | changes in HDL cholesterol from Enrollment to 12 Months | 12 months after the initial primary care visit |
| Changes in LDL Cholesterol | changes in LDL cholesterol from Enrollment to 12 Months | 12 months after the initial primary care visit |
| Changes in Triglycerides | changes in triglycerides from enrollment to 12 months | 12 months after the initial primary care visit |
| Changes in HbA1c Levels | changes in Hemoglobin (HbA1c) levels from enrollment to 12 months | 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). | 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). | 12 months after the initial primary care visit |
| Changes in Self-reported Physical Activity | changes in self-reported physical activity minutes per week | 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. | 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. | 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. | 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. | 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. | 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. | 12 months after the initial primary care visit |
| 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. |
| 31152361 | Derived | 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. |
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.
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | The number analyzed differs from overall because missing data has been excluded from this table. | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | kgs |
|
| Height | Mean | Standard Deviation | centimeters |
|
| Body mass index | Mean | Standard Deviation | kg/m^2 |
|
| Medical conditions | Count of Participants | Participants |
|
| Highest level of education | The number analyzed differs from overall because missing data has been excluded from this table. | Count of Participants | Participants |
|
| Employment status | The number analyzed differs from overall because missing data has been excluded from this table. | Count of Participants | Participants |
|
| Health insurance | Count of Participants | Participants |
|
| Any previous weight loss attempts | The number analyzed differs from overall because missing data has been excluded from this table. | Count of Participants | Participants |
|
| Motivation to lose weight | During the screening process, participants were asked about their motivation to lose weight in the next 6 months, using a 10-point Likert scale where 1= not at all motivated and 10= completely or extremely motivated. This simple measure has been used in previous studies and is associated with behavior change. Only patients who report their level of motivation to be 7 or higher were eligible to participate in the study. | Mean | Standard Deviation | scores on a scale |
|
| Internet use | The number analyzed differs from overall because missing data has been excluded from this table. | Count of Participants | Participants |
|
| Primary language | Count of Participants | Participants |
|
| Use of GLP-1 receptor agonist of SGLT2 inhibitors | Count of Participants | Participants |
|
| OG002 | 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. |
|
|
|
| Secondary | Change in Body Weight at 6 Months | change in body weight from enrollment to 6 months | Posted | Mean | 95% Confidence Interval | kilograms | 6 months after the initial primary care visit |
|
|
|
| Secondary | Change in Body Weight at 18 Months | change in body weight from enrollment to 18 months | Posted | Mean | 95% Confidence Interval | kilograms | 18 months after the initial primary care visit |
|
|
|
|
| Secondary | Percent Weight Change at 6 Months | Percent weight change from enrollment to 6 months | Posted | Mean | 95% Confidence Interval | percentage of weight change | 6 months after the initial primary care visit |
|
|
|
| Secondary | Percent Weight Change at 12-Months | Percent weight change from enrollment to 12 months | Posted | Mean | 95% Confidence Interval | percentage of weight change | 12 months after the initial primary care visit |
|
|
|
|
| Secondary | Percent Weight Change at 18-Months | Percent weight change from enrollment to 18 months | Posted | Mean | 95% Confidence Interval | percentage of weight change | 18 months after the initial primary care visit |
|
|
|
|
| Secondary | 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 | Posted | Mean | 95% Confidence Interval | percentage of patients | 6-months after the initial primary care visit |
|
|
|
| Secondary | 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 | Posted | Mean | 95% Confidence Interval | percentage of patients | 12 months after the initial primary care visit |
|
|
|
|
| Secondary | 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 | Posted | Mean | 95% Confidence Interval | percentage of patients | 18-months after the initial primary care visit |
|
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | 12 months after initial primary care visit |
|
|
|
|
| Secondary | Changes in Systolic Blood Pressure | changes in systolic blood pressure (BP) from enrollment to 12 months | Posted | Mean | 95% Confidence Interval | mmHg | 12 months after the initial primary care visit |
|
|
|
|
| Secondary | Changes in Diastolic Blood Pressure | changes in diastolic blood pressure (BP) from enrollment to 12 months | Posted | Mean | 95% Confidence Interval | mmHg | 12 months after the initial primary care visit |
|
|
|
|
| Secondary | Changes in Total Cholesterol | changes in total cholesterol from Enrollment to 12 Months | Posted | Mean | 95% Confidence Interval | mg/dL | 12 months after the initial primary care visit |
|
|
|
|
| Secondary | Changes in HDL Cholesterol | changes in HDL cholesterol from Enrollment to 12 Months | Posted | Mean | 95% Confidence Interval | mg/dL | 12 months after the initial primary care visit |
|
|
|
|
| Secondary | Changes in LDL Cholesterol | changes in LDL cholesterol from Enrollment to 12 Months | Posted | Mean | 95% Confidence Interval | mg/dL | 12 months after the initial primary care visit |
|
|
|
|
| Secondary | Changes in Triglycerides | changes in triglycerides from enrollment to 12 months | Posted | Mean | 95% Confidence Interval | mg/dL | 12 months after the initial primary care visit |
|
|
|
|
| Secondary | Changes in HbA1c Levels | changes in Hemoglobin (HbA1c) levels from enrollment to 12 months | Posted | Mean | 95% Confidence Interval | % of HbA1c | 12 months after the initial primary care visit |
|
|
|
|
| Secondary | 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). | Posted | Mean | 95% Confidence Interval | score on a scale | 12 months after the initial primary care visit |
|
|
|
|
| Secondary | 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). | Posted | Number | 95% Confidence Interval | percentage of patients | 12 months after the initial primary care visit |
|
|
|
|
| Secondary | Changes in Self-reported Physical Activity | changes in self-reported physical activity minutes per week | Posted | Mean | 95% Confidence Interval | minutes/week | 12 months after the initial primary care visit |
|
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | servings/day | 12 months after the initial primary care visit |
|
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | servings/day | 12 months after the initial primary care visit |
|
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | servings/day | 12 months after the initial primary care visit |
|
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | servings/day | 12 months after the initial primary care visit |
|
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | servings/day | 12 months after the initial primary care visit |
|
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | servings/day | 12 months after the initial primary care visit |
|
|
|
|
| 0 |
| 326 |
| 12 |
| 326 |
| 0 |
| 326 |
| EG001 | 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. | 0 | 216 | 11 | 216 | 0 | 216 |
| EG002 | 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. | 1 | 298 | 18 | 298 | 0 | 298 |
| Coronary arteriogram | Cardiac disorders | Systematic Assessment |
|
| Coronary artery bypass grafting (CABG) | Cardiac disorders | Systematic Assessment |
|
| Dyspnea | Cardiac disorders | Systematic Assessment |
|
| Heart attack | Cardiac disorders | Systematic Assessment |
|
| Pancreatitis | Endocrine disorders | Systematic Assessment |
|
| GI bleed | Gastrointestinal disorders | Systematic Assessment |
|
| Endocarditis | Infections and infestations | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Endometrial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Melanoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Seizure | Nervous system disorders | Systematic Assessment |
|
| Alcohol use disorder | Psychiatric disorders | Systematic Assessment |
|
| Depression | Psychiatric disorders | Systematic Assessment |
|
| Brain surgery | Surgical and medical procedures | Systematic Assessment |
|
| Spinal stenosis of lumbar region | Surgical and medical procedures | Systematic Assessment |
|
| Pulmonary embolism | Vascular disorders | Systematic Assessment |
|
| Transient ischemic attack | Vascular disorders | Systematic Assessment |
|
Not provided
Not provided
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Male |
|
| Black, non-Hispanic |
|
| Hispanic |
|
| Other/multiple categories |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
|
|
| Some college |
|
| College graduate |
|
| Master's, doctorate, or professional degree |
|
| Retired |
|
| Other |
|
| Medicare |
|
| Medicaid/VA |
|
| Several times per week |
|
| Once per day |
|
| >/= Several times per day |
|
| Title | Measurements |
|---|---|
|