Obesity
Conditions
Keywords
Weight Reduction Programs, Weight Loss Programs, Obesity
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.
Interventions
BEHAVIORALOnline 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.
BEHAVIORALPopulation 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.
Sponsors
Patient-Centered Outcomes Research Institute
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Weight at 12 Months | 12 months after the initial primary care visit | change in body weight from enrollment to 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Weight at 18 Months | 18 months after the initial primary care visit | change in body weight from enrollment to 18 months |
| Percent Weight Change at 6 Months | 6 months after the initial primary care visit | Percent weight change from enrollment to 6 months |
| Percent Weight Change at 12-Months | 12 months after the initial primary care visit | Percent weight change from enrollment to 12 months |
| Percent Weight Change at 18-Months | 18 months after the initial primary care visit | Percent weight change from enrollment to 18 months |
| Percent of Patients With at Least 5% Weight Loss at 6 Months | 6-months after the initial primary care visit | Percent of Patients With at Least 5% Weight Loss from enrollment to 6 months |
| Percent of Patients With at Least 5% Weight Loss at 12-months | 12 months after the initial primary care visit | Percent of Patients with at least 5% weight loss from enrollment to 12 months |
| Percent of Patients With at Least 5% Weight Loss at 18 Months | 18-months after the initial primary care visit | Percent of Patients With at least 5% weight loss from enrollment to 18 months |
| Changes in Self-efficacy Around Weight Loss at 12 Months | 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. |
| Changes in Systolic Blood Pressure | 12 months after the initial primary care visit | changes in systolic blood pressure (BP) from enrollment to 12 months |
| Changes in Diastolic Blood Pressure | 12 months after the initial primary care visit | changes in diastolic blood pressure (BP) from enrollment to 12 months |
| Changes in Total Cholesterol | 12 months after the initial primary care visit | changes in total cholesterol from Enrollment to 12 Months |
| Changes in HDL Cholesterol | 12 months after the initial primary care visit | changes in HDL cholesterol from Enrollment to 12 Months |
| Change in Body Weight at 6 Months | 6 months after the initial primary care visit | change in body weight from enrollment to 6 months |
| Changes in Triglycerides | 12 months after the initial primary care visit | changes in triglycerides from enrollment to 12 months |
| Changes in HbA1c Levels | 12 months after the initial primary care visit | changes in Hemoglobin (HbA1c) levels from enrollment to 12 months |
| Changes in Weight-related Quality of Life Assessed by the Impact of Weight on Quality of Life (IWQOL)-Lite Questionnaire | 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). |
| 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) | 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). |
| Changes in Self-reported Physical Activity | 12 months after the initial primary care visit | changes in self-reported physical activity minutes per week |
| Changes in Diet, Specifically Fruits/Vegetables, as Measured by the PrimeScreen Questionnaire | 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. |
| Changes in Diet, Specifically Whole Grains, as Measured by the PrimeScreen Questionnaire | 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. |
| Changes in Diet, Specifically Sugar-sweetened Beverages, as Measured by the PrimeScreen Questionnaire | 12 months after the initial primary care visit | changes in diet, specifically sugar-sweetened beverages as measured by the PrimeScreen questionnaire, a brief dietary screening tool. |
| Changes in Diet, Specifically Baked Products, as Measured by the PrimeScreen Questionnaire | 12 months after the initial primary care visit | changes in diet, specifically baked products as measured by the PrimeScreen questionnaire, a brief dietary screening tool. |
| Changes in Diet, Specifically Processed Meats, as Measured by the PrimeScreen Questionnaire | 12 months after the initial primary care visit | changes in diet, specifically processed meats as measured by the PrimeScreen questionnaire, a brief dietary screening tool. |
| Changes in Diet, Specifically Fried Foods, as Measured by the PrimeScreen Questionnaire | 12 months after the initial primary care visit | changes in diet, specifically fried foods as measured by the PrimeScreen questionnaire, a brief dietary screening tool. |
| Changes in LDL Cholesterol | 12 months after the initial primary care visit | changes in LDL cholesterol from Enrollment to 12 Months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.) | 326 |
| 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. | 216 |
| 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. | 298 |
| Total | 840 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Bariatric surgery | 0 | 1 | 2 |
| Overall Study | Pregnancy | 1 | 1 | 1 |
Baseline characteristics
| Characteristic | Usual Care | Online Program Only | Combined Intervention | Total |
|---|---|---|---|---|
| Age, Continuous | 58.7 years STANDARD_DEVIATION 8.6 | 59.1 years STANDARD_DEVIATION 8.8 | 60.1 years STANDARD_DEVIATION 8.3 | 59.3 years STANDARD_DEVIATION 8.6 |
| Any previous weight loss attempts | 269 Participants | 182 Participants | 236 Participants | 687 Participants |
| Body mass index | 32.7 kg/m^2 STANDARD_DEVIATION 3.3 | 32.2 kg/m^2 STANDARD_DEVIATION 3.2 | 32.4 kg/m^2 STANDARD_DEVIATION 3.4 | 32.5 kg/m^2 STANDARD_DEVIATION 3.3 |
| Employment status Employed (full-time or part-time) | 206 Participants | 139 Participants | 169 Participants | 514 Participants |
| Employment status Other | 45 Participants | 41 Participants | 54 Participants | 140 Participants |
| Employment status Retired | 63 Participants | 33 Participants | 65 Participants | 161 Participants |
| Health insurance Medicaid/VA | 37 Participants | 25 Participants | 23 Participants | 85 Participants |
| Health insurance Medicare | 72 Participants | 50 Participants | 68 Participants | 190 Participants |
| Health insurance Private | 217 Participants | 141 Participants | 207 Participants | 565 Participants |
| Height | 167.4 centimeters STANDARD_DEVIATION 9.4 | 168.7 centimeters STANDARD_DEVIATION 9.9 | 169.2 centimeters STANDARD_DEVIATION 9.9 | 168.4 centimeters STANDARD_DEVIATION 9.9 |
| Highest level of education College graduate | 102 Participants | 66 Participants | 83 Participants | 251 Participants |
| Highest level of education High school graduate or less | 23 Participants | 16 Participants | 14 Participants | 53 Participants |
| Highest level of education Master's, doctorate, or professional degree | 72 Participants | 65 Participants | 111 Participants | 248 Participants |
| Highest level of education Some college | 91 Participants | 45 Participants | 50 Participants | 186 Participants |
| Internet use Once per day | 23 Participants | 9 Participants | 14 Participants | 46 Participants |
| Internet use </= Once per week | 6 Participants | 2 Participants | 4 Participants | 12 Participants |
| Internet use >/= Several times per day | 244 Participants | 167 Participants | 234 Participants | 645 Participants |
| Internet use Several times per week | 14 Participants | 13 Participants | 8 Participants | 35 Participants |
| Medical conditions Coronary heart disease/ atherosclerosis | 2 Participants | 1 Participants | 4 Participants | 7 Participants |
| Medical conditions Hypercholesterolemia | 67 Participants | 60 Participants | 56 Participants | 183 Participants |
| Medical conditions Hypertension | 312 Participants | 211 Participants | 287 Participants | 810 Participants |
| Medical conditions Non-alcoholic fatty liver disease | 1 Participants | 1 Participants | 3 Participants | 5 Participants |
| Medical conditions Obstructive sleep apnea | 53 Participants | 36 Participants | 56 Participants | 145 Participants |
| Medical conditions Type 2 diabetes | 73 Participants | 49 Participants | 83 Participants | 205 Participants |
| Motivation to lose weight | 8.8 scores on a scale STANDARD_DEVIATION 1.1 | 8.9 scores on a scale STANDARD_DEVIATION 1.1 | 8.9 scores on a scale STANDARD_DEVIATION 1.1 | 8.9 scores on a scale STANDARD_DEVIATION 1.1 |
| Primary language English | 315 Participants | 212 Participants | 288 Participants | 815 Participants |
| Primary language Spanish | 11 Participants | 4 Participants | 10 Participants | 25 Participants |
| Race/Ethnicity, Customized Black, non-Hispanic | 39 Participants | 23 Participants | 31 Participants | 93 Participants |
| Race/Ethnicity, Customized Hispanic | 24 Participants | 12 Participants | 20 Participants | 56 Participants |
| Race/Ethnicity, Customized Other/multiple categories | 14 Participants | 11 Participants | 17 Participants | 42 Participants |
| Race/Ethnicity, Customized White, non-Hispanic | 249 Participants | 169 Participants | 227 Participants | 645 Participants |
| Sex: Female, Male Female | 217 Participants | 128 Participants | 159 Participants | 504 Participants |
| Sex: Female, Male Male | 109 Participants | 88 Participants | 139 Participants | 336 Participants |
| Use of GLP-1 receptor agonist of SGLT2 inhibitors | 1 Participants | 1 Participants | 5 Participants | 7 Participants |
| Weight | 91.8 kgs STANDARD_DEVIATION 14.4 | 91.6 kgs STANDARD_DEVIATION 14.4 | 92.9 kgs STANDARD_DEVIATION 13.8 | 92.1 kgs STANDARD_DEVIATION 14.3 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 326 | 0 / 216 | 1 / 298 |
| other Total, other adverse events | 0 / 326 | 0 / 216 | 0 / 298 |
| serious Total, serious adverse events | 12 / 326 | 11 / 216 | 18 / 298 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Change in Body Weight at 12 Months | -1.2 kilograms |
| Online Program Only | Change in Body Weight at 12 Months | -1.9 kilograms |
| Combined Intervention | Change in Body Weight at 12 Months | -3.1 kilograms |
p-value: 0.00017Mixed Models Analysis
Secondary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Change in Body Weight at 18 Months | -1.9 kilograms |
| Online Program Only | Change in Body Weight at 18 Months | -1.1 kilograms |
| Combined Intervention | Change in Body Weight at 18 Months | -2.8 kilograms |
p-value: <0.001Mixed Models Analysis
Secondary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Change in Body Weight at 6 Months | -1.0 kilograms |
| Online Program Only | Change in Body Weight at 6 Months | -2.1 kilograms |
| Combined Intervention | Change in Body Weight at 6 Months | -2.9 kilograms |
Secondary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Changes in Diastolic Blood Pressure | -1.0 mmHg |
| Online Program Only | Changes in Diastolic Blood Pressure | -2.2 mmHg |
| Combined Intervention | Changes in Diastolic Blood Pressure | -1.1 mmHg |
p-value: 0.35Mixed Models Analysis
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.
Time frame: 12 months after the initial primary care visit
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Changes in Diet, Specifically Baked Products, as Measured by the PrimeScreen Questionnaire | -0.1 servings/day |
| Online Program Only | Changes in Diet, Specifically Baked Products, as Measured by the PrimeScreen Questionnaire | -0.1 servings/day |
| Combined Intervention | Changes in Diet, Specifically Baked Products, as Measured by the PrimeScreen Questionnaire | -0.1 servings/day |
p-value: 0.42Mixed Models Analysis
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.
Time frame: 12 months after the initial primary care visit
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Changes in Diet, Specifically Fried Foods, as Measured by the PrimeScreen Questionnaire | -0.03 servings/day |
| Online Program Only | Changes in Diet, Specifically Fried Foods, as Measured by the PrimeScreen Questionnaire | -0.02 servings/day |
| Combined Intervention | Changes in Diet, Specifically Fried Foods, as Measured by the PrimeScreen Questionnaire | -0.1 servings/day |
p-value: 0.2Mixed Models Analysis
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.
Time frame: 12 months after the initial primary care visit
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Changes in Diet, Specifically Fruits/Vegetables, as Measured by the PrimeScreen Questionnaire | 0.4 servings/day |
| Online Program Only | Changes in Diet, Specifically Fruits/Vegetables, as Measured by the PrimeScreen Questionnaire | 0.3 servings/day |
| Combined Intervention | Changes in Diet, Specifically Fruits/Vegetables, as Measured by the PrimeScreen Questionnaire | 0.4 servings/day |
p-value: 0.68Mixed Models Analysis
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.
Time frame: 12 months after the initial primary care visit
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Changes in Diet, Specifically Processed Meats, as Measured by the PrimeScreen Questionnaire | -0.02 servings/day |
| Online Program Only | Changes in Diet, Specifically Processed Meats, as Measured by the PrimeScreen Questionnaire | -0.1 servings/day |
| Combined Intervention | Changes in Diet, Specifically Processed Meats, as Measured by the PrimeScreen Questionnaire | -0.1 servings/day |
p-value: 0.23Mixed Models Analysis
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.
Time frame: 12 months after the initial primary care visit
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Changes in Diet, Specifically Sugar-sweetened Beverages, as Measured by the PrimeScreen Questionnaire | 0.01 servings/day |
| Online Program Only | Changes in Diet, Specifically Sugar-sweetened Beverages, as Measured by the PrimeScreen Questionnaire | -0.1 servings/day |
| Combined Intervention | Changes in Diet, Specifically Sugar-sweetened Beverages, as Measured by the PrimeScreen Questionnaire | -0.1 servings/day |
p-value: 0.09Mixed Models Analysis
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.
Time frame: 12 months after the initial primary care visit
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Changes in Diet, Specifically Whole Grains, as Measured by the PrimeScreen Questionnaire | 0.02 servings/day |
| Online Program Only | Changes in Diet, Specifically Whole Grains, as Measured by the PrimeScreen Questionnaire | 0.03 servings/day |
| Combined Intervention | Changes in Diet, Specifically Whole Grains, as Measured by the PrimeScreen Questionnaire | 0.1 servings/day |
p-value: 0.54Mixed Models Analysis
Secondary
Changes in HbA1c Levels
changes in Hemoglobin (HbA1c) levels from enrollment to 12 months
Time frame: 12 months after the initial primary care visit
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Changes in HbA1c Levels | -0.02 % of HbA1c |
| Online Program Only | Changes in HbA1c Levels | 0.02 % of HbA1c |
| Combined Intervention | Changes in HbA1c Levels | -0.02 % of HbA1c |
p-value: 0.16Mixed Models Analysis
Secondary
Changes in HDL Cholesterol
changes in HDL cholesterol from Enrollment to 12 Months
Time frame: 12 months after the initial primary care visit
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Changes in HDL Cholesterol | -0.4 mg/dL |
| Online Program Only | Changes in HDL Cholesterol | 0.6 mg/dL |
| Combined Intervention | Changes in HDL Cholesterol | 0.7 mg/dL |
p-value: 0.33Mixed Models Analysis
Secondary
Changes in LDL Cholesterol
changes in LDL cholesterol from Enrollment to 12 Months
Time frame: 12 months after the initial primary care visit
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Changes in LDL Cholesterol | -5.4 mg/dL |
| Online Program Only | Changes in LDL Cholesterol | -3.7 mg/dL |
| Combined Intervention | Changes in LDL Cholesterol | -5.8 mg/dL |
p-value: 0.43Mixed Models Analysis
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).
Time frame: 12 months after the initial primary care visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care | 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) | 14.5 percentage of patients |
| Online Program Only | 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) | 16.1 percentage of patients |
| Combined Intervention | 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) | 21.4 percentage of patients |
p-value: 0.61Mixed Models Analysis
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.
Time frame: 12 months after initial primary care visit
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Changes in Self-efficacy Around Weight Loss at 12 Months | -0.7 score on a scale |
| Online Program Only | Changes in Self-efficacy Around Weight Loss at 12 Months | -0.4 score on a scale |
| Combined Intervention | Changes in Self-efficacy Around Weight Loss at 12 Months | 0.5 score on a scale |
p-value: 0.0001Mixed Models Analysis
Secondary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Changes in Self-reported Physical Activity | 5.7 minutes/week |
| Online Program Only | Changes in Self-reported Physical Activity | 2.6 minutes/week |
| Combined Intervention | Changes in Self-reported Physical Activity | 3.5 minutes/week |
p-value: 0.46Mixed Models Analysis
Secondary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Changes in Systolic Blood Pressure | -0.9 mmHg |
| Online Program Only | Changes in Systolic Blood Pressure | -3.0 mmHg |
| Combined Intervention | Changes in Systolic Blood Pressure | -0.2 mmHg |
p-value: 0.19Mixed Models Analysis
Secondary
Changes in Total Cholesterol
changes in total cholesterol from Enrollment to 12 Months
Time frame: 12 months after the initial primary care visit
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Changes in Total Cholesterol | -7.5 mg/dL |
| Online Program Only | Changes in Total Cholesterol | -6.3 mg/dL |
| Combined Intervention | Changes in Total Cholesterol | -6.8 mg/dL |
p-value: 0.2Mixed Models Analysis
Secondary
Changes in Triglycerides
changes in triglycerides from enrollment to 12 months
Time frame: 12 months after the initial primary care visit
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Changes in Triglycerides | -12.4 mg/dL |
| Online Program Only | Changes in Triglycerides | -8.0 mg/dL |
| Combined Intervention | Changes in Triglycerides | -10.2 mg/dL |
p-value: 0.4Mixed Models Analysis
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).
Time frame: 12 months after the initial primary care visit
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Changes in Weight-related Quality of Life Assessed by the Impact of Weight on Quality of Life (IWQOL)-Lite Questionnaire | 5.4 score on a scale |
| Online Program Only | Changes in Weight-related Quality of Life Assessed by the Impact of Weight on Quality of Life (IWQOL)-Lite Questionnaire | 4.8 score on a scale |
| Combined Intervention | Changes in Weight-related Quality of Life Assessed by the Impact of Weight on Quality of Life (IWQOL)-Lite Questionnaire | 5.8 score on a scale |
p-value: 0.61Mixed Models Analysis
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
Time frame: 12 months after the initial primary care visit
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Percent of Patients With at Least 5% Weight Loss at 12-months | 14.9 percentage of patients |
| Online Program Only | Percent of Patients With at Least 5% Weight Loss at 12-months | 20.8 percentage of patients |
| Combined Intervention | Percent of Patients With at Least 5% Weight Loss at 12-months | 32.3 percentage of patients |
p-value: <0.001Mixed Models Analysis
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
Time frame: 18-months after the initial primary care visit
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Percent of Patients With at Least 5% Weight Loss at 18 Months | 20.9 percentage of patients |
| Online Program Only | Percent of Patients With at Least 5% Weight Loss at 18 Months | 19.9 percentage of patients |
| Combined Intervention | Percent of Patients With at Least 5% Weight Loss at 18 Months | 31.3 percentage of patients |
p-value: 0.2Mixed Models Analysis
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
Time frame: 6-months after the initial primary care visit
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Percent of Patients With at Least 5% Weight Loss at 6 Months | 13.4 percentage of patients |
| Online Program Only | Percent of Patients With at Least 5% Weight Loss at 6 Months | 22.1 percentage of patients |
| Combined Intervention | Percent of Patients With at Least 5% Weight Loss at 6 Months | 29.5 percentage of patients |
Secondary
Percent Weight Change at 12-Months
Percent weight change from enrollment to 12 months
Time frame: 12 months after the initial primary care visit
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Percent Weight Change at 12-Months | -1.4 percentage of weight change |
| Online Program Only | Percent Weight Change at 12-Months | -1.9 percentage of weight change |
| Combined Intervention | Percent Weight Change at 12-Months | -3.0 percentage of weight change |
p-value: <0.001Mixed Models Analysis
Secondary
Percent Weight Change at 18-Months
Percent weight change from enrollment to 18 months
Time frame: 18 months after the initial primary care visit
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Percent Weight Change at 18-Months | -1.9 percentage of weight change |
| Online Program Only | Percent Weight Change at 18-Months | -0.9 percentage of weight change |
| Combined Intervention | Percent Weight Change at 18-Months | -2.6 percentage of weight change |
p-value: 0.01Mixed Models Analysis
Secondary
Percent Weight Change at 6 Months
Percent weight change from enrollment to 6 months
Time frame: 6 months after the initial primary care visit
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Percent Weight Change at 6 Months | -1.0 percentage of weight change |
| Online Program Only | Percent Weight Change at 6 Months | -2.0 percentage of weight change |
| Combined Intervention | Percent Weight Change at 6 Months | -2.8 percentage of weight change |