PROPS: Integrating Online Weight Management With Primary Care Support

• Sponsor: Brigham and Women's Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02656693
• Collaborator: Patient-Centered Outcomes Research Institute (Other)
• Enrollment: 840
• Location: 1
• Arms: 3
• Actual Duration (Months): 33.6
• Patients Per Site Per Month: 25

Study Details

Study Description

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. 1. 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.

1. 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.

1. 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.

1. 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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Behavioral: Online weight management program; Behavioral: Population health management support	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 840 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Integrating Online Weight Management With Primary Care Support: Patient-Centered Strategies for Addressing Overweight and Obesity in Primary Care
• Actual Study Start Date: Jul 19, 2016
• Actual Primary Completion Date: Nov 8, 2018
• Actual Study Completion Date: May 8, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Online Program Only Patients will use an online weight management program called BMIQ, with minimal additional support.	Behavioral: 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.
Experimental: 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.	Behavioral: 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.; Behavioral: 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.
No Intervention: Usual Care Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Change in Body Weight at 6 Months [6 months after the initial primary care visit]

   change in body weight from enrollment to 6 months

2. Change in Body Weight at 18 Months [18 months after the initial primary care visit]

   change in body weight from enrollment to 18 months

3. Percent Weight Change at 6 Months [6 months after the initial primary care visit]

   Percent weight change from enrollment to 6 months

4. Percent Weight Change at 12-Months [12 months after the initial primary care visit]

   Percent weight change from enrollment to 12 months

5. Percent Weight Change at 18-Months [18 months after the initial primary care visit]

   Percent weight change from enrollment to 18 months

6. 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

7. 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

8. 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

9. 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.

10. Changes in Systolic Blood Pressure [12 months after the initial primary care visit]

    changes in systolic blood pressure (BP) from enrollment to 12 months

11. Changes in Diastolic Blood Pressure [12 months after the initial primary care visit]

    changes in diastolic blood pressure (BP) from enrollment to 12 months

12. Changes in Total Cholesterol [12 months after the initial primary care visit]

    changes in total cholesterol from Enrollment to 12 Months

13. Changes in HDL Cholesterol [12 months after the initial primary care visit]

    changes in HDL cholesterol from Enrollment to 12 Months

14. Changes in LDL Cholesterol [12 months after the initial primary care visit]

    changes in LDL cholesterol from Enrollment to 12 Months

15. Changes in Triglycerides [12 months after the initial primary care visit]

    changes in triglycerides from enrollment to 12 months

16. Changes in HbA1c Levels [12 months after the initial primary care visit]

    changes in Hemoglobin (HbA1c) levels from enrollment to 12 months

17. 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).

18. 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).

19. Changes in Self-reported Physical Activity [12 months after the initial primary care visit]

    changes in self-reported physical activity minutes per week

20. 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.

21. 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.

22. 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.

23. 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.

24. 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.

25. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts 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.

2. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

• Brigham and Women's Hospital
• Patient-Centered Outcomes Research Institute

Investigators

• Principal Investigator: Heather Baer, ScD, Brigham and Women's Hospital

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 11, 2019

More Information

Publications

None provided.

• Responsible Party: Heather J. Baer, Associate Epidemiologist, Brigham and Women's Hospital
• ClinicalTrials.gov Identifier: NCT02656693
• Other Study ID Numbers: 2015P002372
• First Posted: Jan 15, 2016
• Last Update Posted: Nov 5, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Heather J. Baer, Associate Epidemiologist, Brigham and Women's Hospital: Weight Reduction Programs; Weight Loss Programs; Obesity
• Additional relevant MeSH terms: Obesity

Study Results

Participant Flow

Arm/Group Title	Usual Care	Online Program Only	Combined Intervention
Arm/Group Description	Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	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.	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.
Period Title: Overall Study
STARTED	326	216	298
COMPLETED	325	214	295
NOT COMPLETED	1	2	3

Baseline Characteristics

Arm/Group Title	Usual Care	Online Program Only	Combined Intervention	Total
Arm/Group Description	Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	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.	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.	Total of all reporting groups
Overall Participants	326	216	298	840
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58.7 (8.6)	59.1 (8.8)	60.1 (8.3)	59.3 (8.6)
Sex: Female, Male (Count of Participants)
Female	217 66.6%	128 59.3%	159 53.4%	504 60%
Male	109 33.4%	88 40.7%	139 46.6%	336 40%
Race/Ethnicity, Customized (Count of Participants)
White, non-Hispanic	249 76.4%	169 78.2%	227 76.2%	645 76.8%
Black, non-Hispanic	39 12%	23 10.6%	31 10.4%	93 11.1%
Hispanic	24 7.4%	12 5.6%	20 6.7%	56 6.7%
Other/multiple categories	14 4.3%	11 5.1%	17 5.7%	42 5%
Weight (kgs) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kgs]	91.8 (14.4)	91.6 (14.4)	92.9 (13.8)	92.1 (14.3)
Height (centimeters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [centimeters]	167.4 (9.4)	168.7 (9.9)	169.2 (9.9)	168.4 (9.9)
Body mass index (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	32.7 (3.3)	32.2 (3.2)	32.4 (3.4)	32.5 (3.3)
Medical conditions (Count of Participants)
Hypertension	312 95.7%	211 97.7%	287 96.3%	810 96.4%
Type 2 diabetes	73 22.4%	49 22.7%	83 27.9%	205 24.4%
Hypercholesterolemia	67 20.6%	60 27.8%	56 18.8%	183 21.8%
Obstructive sleep apnea	53 16.3%	36 16.7%	56 18.8%	145 17.3%
Coronary heart disease/ atherosclerosis	2 0.6%	1 0.5%	4 1.3%	7 0.8%
Non-alcoholic fatty liver disease	1 0.3%	1 0.5%	3 1%	5 0.6%
Highest level of education (Count of Participants)
High school graduate or less	23 7.1%	16 7.4%	14 4.7%	53 6.3%
Some college	91 27.9%	45 20.8%	50 16.8%	186 22.1%
College graduate	102 31.3%	66 30.6%	83 27.9%	251 29.9%
Master's, doctorate, or professional degree	72 22.1%	65 30.1%	111 37.2%	248 29.5%
Employment status (Count of Participants)
Employed (full-time or part-time)	206 63.2%	139 64.4%	169 56.7%	514 61.2%
Retired	63 19.3%	33 15.3%	65 21.8%	161 19.2%
Other	45 13.8%	41 19%	54 18.1%	140 16.7%
Health insurance (Count of Participants)
Private	217 66.6%	141 65.3%	207 69.5%	565 67.3%
Medicare	72 22.1%	50 23.1%	68 22.8%	190 22.6%
Medicaid/VA	37 11.3%	25 11.6%	23 7.7%	85 10.1%
Any previous weight loss attempts (Count of Participants)
Count of Participants [Participants]	269 82.5%	182 84.3%	236 79.2%	687 81.8%
Motivation to lose weight (scores on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [scores on a scale]	8.8 (1.1)	8.9 (1.1)	8.9 (1.1)	8.9 (1.1)
Internet use (Count of Participants)
</= Once per week	6 1.8%	2 0.9%	4 1.3%	12 1.4%
Several times per week	14 4.3%	13 6%	8 2.7%	35 4.2%
Once per day	23 7.1%	9 4.2%	14 4.7%	46 5.5%
>/= Several times per day	244 74.8%	167 77.3%	234 78.5%	645 76.8%
Primary language (Count of Participants)
English	315 96.6%	212 98.1%	288 96.6%	815 97%
Spanish	11 3.4%	4 1.9%	10 3.4%	25 3%
Use of GLP-1 receptor agonist of SGLT2 inhibitors (Count of Participants)
Count of Participants [Participants]	1 0.3%	1 0.5%	5 1.7%	7 0.8%

Outcome Measures

1. Primary Outcome

Title	Change in Body Weight at 12 Months
Description	change in body weight from enrollment to 12 months
Time Frame	12 months after the initial primary care visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Online Program Only	Combined Intervention
Arm/Group Description	Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	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.	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.
Measure Participants	326	216	298
Mean (95% Confidence Interval) [kilograms]	-1.2	-1.9	-3.1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Online Program Only, Combined Intervention
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.00017
	Comments
	Method	Mixed Models Analysis
	Comments

2. Secondary Outcome

Title	Change in Body Weight at 6 Months
Description	change in body weight from enrollment to 6 months
Time Frame	6 months after the initial primary care visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Online Program Only	Combined Intervention
Arm/Group Description	Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	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.	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.
Measure Participants	326	216	298
Mean (95% Confidence Interval) [kilograms]	-1.0	-2.1	-2.9

3. Secondary Outcome

Title	Change in Body Weight at 18 Months
Description	change in body weight from enrollment to 18 months
Time Frame	18 months after the initial primary care visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Online Program Only	Combined Intervention
Arm/Group Description	Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	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.	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.
Measure Participants	326	216	298
Mean (95% Confidence Interval) [kilograms]	-1.9	-1.1	-2.8

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Online Program Only, Combined Intervention
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	< 0.001
	Comments
	Method	Mixed Models Analysis
	Comments

4. Secondary Outcome

Title	Percent Weight Change at 6 Months
Description	Percent weight change from enrollment to 6 months
Time Frame	6 months after the initial primary care visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Online Program Only	Combined Intervention
Arm/Group Description	Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	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.	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.
Measure Participants	326	216	298
Mean (95% Confidence Interval) [percentage of weight change]	-1.0	-2.0	-2.8

5. Secondary Outcome

Title	Percent Weight Change at 12-Months
Description	Percent weight change from enrollment to 12 months
Time Frame	12 months after the initial primary care visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Online Program Only	Combined Intervention
Arm/Group Description	Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	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.	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.
Measure Participants	326	216	298
Mean (95% Confidence Interval) [percentage of weight change]	-1.4	-1.9	-3.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Online Program Only, Combined Intervention
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	< 0.001
	Comments
	Method	Mixed Models Analysis
	Comments

6. Secondary Outcome

Title	Percent Weight Change at 18-Months
Description	Percent weight change from enrollment to 18 months
Time Frame	18 months after the initial primary care visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Online Program Only	Combined Intervention
Arm/Group Description	Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	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.	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.
Measure Participants	326	216	298
Mean (95% Confidence Interval) [percentage of weight change]	-1.9	-0.9	-2.6

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Combined Intervention
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.01
	Comments
	Method	Mixed Models Analysis
	Comments

7. Secondary Outcome

Title	Percent of Patients With at Least 5% Weight Loss at 6 Months
Description	Percent of Patients With at Least 5% Weight Loss from enrollment to 6 months
Time Frame	6-months after the initial primary care visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Online Program Only	Combined Intervention
Arm/Group Description	Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	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.	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.
Measure Participants	326	216	298
Mean (95% Confidence Interval) [percentage of patients]	13.4	22.1	29.5

8. Secondary Outcome

Title	Percent of Patients With at Least 5% Weight Loss at 12-months
Description	Percent of Patients with at least 5% weight loss from enrollment to 12 months
Time Frame	12 months after the initial primary care visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Online Program Only	Combined Intervention
Arm/Group Description	Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	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.	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.
Measure Participants	326	216	298
Mean (95% Confidence Interval) [percentage of patients]	14.9	20.8	32.3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Online Program Only, Combined Intervention
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments

9. Secondary Outcome

Title	Percent of Patients With at Least 5% Weight Loss at 18 Months
Description	Percent of Patients With at least 5% weight loss from enrollment to 18 months
Time Frame	18-months after the initial primary care visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Online Program Only	Combined Intervention
Arm/Group Description	Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	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.	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.
Measure Participants	326	216	298
Mean (95% Confidence Interval) [percentage of patients]	20.9	19.9	31.3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Online Program Only, Combined Intervention
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.20
	Comments
	Method	Mixed Models Analysis
	Comments

10. Secondary Outcome

Title	Changes in Self-efficacy Around Weight Loss at 12 Months
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Online Program Only	Combined Intervention
Arm/Group Description	Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	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.	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.
Measure Participants	326	216	298
Mean (95% Confidence Interval) [score on a scale]	-0.7	-0.4	0.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Online Program Only, Combined Intervention
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0001
	Comments
	Method	Mixed Models Analysis
	Comments

11. Secondary Outcome

Title	Changes in Systolic Blood Pressure
Description	changes in systolic blood pressure (BP) from enrollment to 12 months
Time Frame	12 months after the initial primary care visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Online Program Only	Combined Intervention
Arm/Group Description	Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	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.	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.
Measure Participants	326	216	298
Mean (95% Confidence Interval) [mmHg]	-0.9	-3.0	-0.2

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Online Program Only, Combined Intervention
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.19
	Comments
	Method	Mixed Models Analysis
	Comments

12. Secondary Outcome

Title	Changes in Diastolic Blood Pressure
Description	changes in diastolic blood pressure (BP) from enrollment to 12 months
Time Frame	12 months after the initial primary care visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Online Program Only	Combined Intervention
Arm/Group Description	Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	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.	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.
Measure Participants	326	216	298
Mean (95% Confidence Interval) [mmHg]	-1.0	-2.2	-1.1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Online Program Only, Combined Intervention
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.35
	Comments
	Method	Mixed Models Analysis
	Comments

13. Secondary Outcome

Title	Changes in Total Cholesterol
Description	changes in total cholesterol from Enrollment to 12 Months
Time Frame	12 months after the initial primary care visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Online Program Only	Combined Intervention
Arm/Group Description	Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	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.	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.
Measure Participants	326	216	298
Mean (95% Confidence Interval) [mg/dL]	-7.5	-6.3	-6.8

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Online Program Only, Combined Intervention
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.20
	Comments
	Method	Mixed Models Analysis
	Comments

14. Secondary Outcome

Title	Changes in HDL Cholesterol
Description	changes in HDL cholesterol from Enrollment to 12 Months
Time Frame	12 months after the initial primary care visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Online Program Only	Combined Intervention
Arm/Group Description	Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	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.	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.
Measure Participants	326	216	298
Mean (95% Confidence Interval) [mg/dL]	-0.4	0.6	0.7

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Online Program Only, Combined Intervention
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.33
	Comments
	Method	Mixed Models Analysis
	Comments

15. Secondary Outcome

Title	Changes in LDL Cholesterol
Description	changes in LDL cholesterol from Enrollment to 12 Months
Time Frame	12 months after the initial primary care visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Online Program Only	Combined Intervention
Arm/Group Description	Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	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.	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.
Measure Participants	326	216	298
Mean (95% Confidence Interval) [mg/dL]	-5.4	-3.7	-5.8

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Online Program Only, Combined Intervention
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.43
	Comments
	Method	Mixed Models Analysis
	Comments

16. Secondary Outcome

Title	Changes in Triglycerides
Description	changes in triglycerides from enrollment to 12 months
Time Frame	12 months after the initial primary care visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Online Program Only	Combined Intervention
Arm/Group Description	Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	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.	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.
Measure Participants	326	216	298
Mean (95% Confidence Interval) [mg/dL]	-12.4	-8.0	-10.2

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Online Program Only, Combined Intervention
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.40
	Comments
	Method	Mixed Models Analysis
	Comments

17. Secondary Outcome

Title	Changes in HbA1c Levels
Description	changes in Hemoglobin (HbA1c) levels from enrollment to 12 months
Time Frame	12 months after the initial primary care visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Online Program Only	Combined Intervention
Arm/Group Description	Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	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.	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.
Measure Participants	326	216	298
Mean (95% Confidence Interval) [% of HbA1c]	-0.02	0.02	-0.02

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Online Program Only, Combined Intervention
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.16
	Comments
	Method	Mixed Models Analysis
	Comments

18. Secondary Outcome

Title	Changes in Weight-related Quality of Life Assessed by the Impact of Weight on Quality of Life (IWQOL)-Lite Questionnaire
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Online Program Only	Combined Intervention
Arm/Group Description	Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	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.	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.
Measure Participants	326	216	298
Mean (95% Confidence Interval) [score on a scale]	5.4	4.8	5.8

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Online Program Only, Combined Intervention
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.61
	Comments
	Method	Mixed Models Analysis
	Comments

19. Secondary Outcome

Title	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)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Online Program Only	Combined Intervention
Arm/Group Description	Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	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.	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.
Measure Participants	326	216	298
Number (95% Confidence Interval) [percentage of patients]	14.5	16.1	21.4

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Online Program Only, Combined Intervention
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.61
	Comments
	Method	Mixed Models Analysis
	Comments

20. Secondary Outcome

Title	Changes in Self-reported Physical Activity
Description	changes in self-reported physical activity minutes per week
Time Frame	12 months after the initial primary care visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Online Program Only	Combined Intervention
Arm/Group Description	Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	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.	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.
Measure Participants	326	216	298
Mean (95% Confidence Interval) [minutes/week]	5.7	2.6	3.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Online Program Only, Combined Intervention
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.46
	Comments
	Method	Mixed Models Analysis
	Comments

21. Secondary Outcome

Title	Changes in Diet, Specifically Fruits/Vegetables, as Measured by the PrimeScreen Questionnaire
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Online Program Only	Combined Intervention
Arm/Group Description	Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	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.	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.
Measure Participants	326	216	298
Mean (95% Confidence Interval) [servings/day]	0.4	0.3	0.4

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Online Program Only, Combined Intervention
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.68
	Comments
	Method	Mixed Models Analysis
	Comments

22. Secondary Outcome

Title	Changes in Diet, Specifically Whole Grains, as Measured by the PrimeScreen Questionnaire
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Online Program Only	Combined Intervention
Arm/Group Description	Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	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.	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.
Measure Participants	326	216	298
Mean (95% Confidence Interval) [servings/day]	0.02	0.03	0.1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Online Program Only, Combined Intervention
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.54
	Comments
	Method	Mixed Models Analysis
	Comments

23. Secondary Outcome

Title	Changes in Diet, Specifically Sugar-sweetened Beverages, as Measured by the PrimeScreen Questionnaire
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Online Program Only	Combined Intervention
Arm/Group Description	Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	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.	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.
Measure Participants	326	216	298
Mean (95% Confidence Interval) [servings/day]	0.01	-0.1	-0.1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Online Program Only, Combined Intervention
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.09
	Comments
	Method	Mixed Models Analysis
	Comments

24. Secondary Outcome

Title	Changes in Diet, Specifically Baked Products, as Measured by the PrimeScreen Questionnaire
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Online Program Only	Combined Intervention
Arm/Group Description	Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	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.	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.
Measure Participants	326	216	298
Mean (95% Confidence Interval) [servings/day]	-0.1	-0.1	-0.1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Online Program Only, Combined Intervention
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.42
	Comments
	Method	Mixed Models Analysis
	Comments

25. Secondary Outcome

Title	Changes in Diet, Specifically Processed Meats, as Measured by the PrimeScreen Questionnaire
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Online Program Only	Combined Intervention
Arm/Group Description	Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	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.	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.
Measure Participants	326	216	298
Mean (95% Confidence Interval) [servings/day]	-0.02	-0.1	-0.1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Online Program Only, Combined Intervention
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.23
	Comments
	Method	Mixed Models Analysis
	Comments

26. Secondary Outcome

Title	Changes in Diet, Specifically Fried Foods, as Measured by the PrimeScreen Questionnaire
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Online Program Only	Combined Intervention
Arm/Group Description	Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	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.	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.
Measure Participants	326	216	298
Mean (95% Confidence Interval) [servings/day]	-0.03	-0.02	-0.1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Online Program Only, Combined Intervention
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.20
	Comments
	Method	Mixed Models Analysis
	Comments

Adverse Events

Time Frame	Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study.
Adverse Event Reporting Description	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.
Arm/Group Title	Usual Care		Online Program Only		Combined Intervention
Arm/Group Description	Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)		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.		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.
All Cause Mortality
	Usual Care		Online Program Only		Combined Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/326 (0%)		0/216 (0%)		1/298 (0.3%)
Serious Adverse Events
	Usual Care		Online Program Only		Combined Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/326 (3.7%)		11/216 (5.1%)		18/298 (6%)
Cardiac disorders
Angina	0/326 (0%)	0	1/216 (0.5%)	1	0/298 (0%)	0
Coronary arteriogram	0/326 (0%)	0	0/216 (0%)	0	1/298 (0.3%)	1
Coronary artery bypass grafting (CABG)	1/326 (0.3%)	1	2/216 (0.9%)	2	0/298 (0%)	0
Dyspnea	0/326 (0%)	0	0/216 (0%)	0	1/298 (0.3%)	1
Heart attack	1/326 (0.3%)	1	2/216 (0.9%)	2	0/298 (0%)	0
Endocrine disorders
Pancreatitis	0/326 (0%)	0	0/216 (0%)	0	2/298 (0.7%)	2
Gastrointestinal disorders
GI bleed	1/326 (0.3%)	1	0/216 (0%)	0	1/298 (0.3%)	1
Infections and infestations
Endocarditis	0/326 (0%)	0	0/216 (0%)	0	1/298 (0.3%)	1
Injury, poisoning and procedural complications
Fall	0/326 (0%)	0	0/216 (0%)	0	1/298 (0.3%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer	2/326 (0.6%)	2	0/216 (0%)	0	0/298 (0%)	0
Breast cancer	3/326 (0.9%)	3	0/216 (0%)	0	3/298 (1%)	3
Endometrial cancer	0/326 (0%)	0	0/216 (0%)	0	1/298 (0.3%)	1
Melanoma in situ	1/326 (0.3%)	1	0/216 (0%)	0	0/298 (0%)	0
Prostate cancer	1/326 (0.3%)	1	4/216 (1.9%)	4	1/298 (0.3%)	1
Squamous cell carcinoma	0/326 (0%)	0	0/216 (0%)	0	1/298 (0.3%)	1
Nervous system disorders
Headache	0/326 (0%)	0	0/216 (0%)	0	1/298 (0.3%)	1
Seizure	1/326 (0.3%)	1	0/216 (0%)	0	0/298 (0%)	0
Psychiatric disorders
Alcohol use disorder	0/326 (0%)	0	0/216 (0%)	0	1/298 (0.3%)	1
Depression	0/326 (0%)	0	0/216 (0%)	0	1/298 (0.3%)	1
Surgical and medical procedures
Brain surgery	0/326 (0%)	0	1/216 (0.5%)	1	0/298 (0%)	0
Spinal stenosis of lumbar region	0/326 (0%)	0	1/216 (0.5%)	1	0/298 (0%)	0
Vascular disorders
Pulmonary embolism	1/326 (0.3%)	1	1/216 (0.5%)	1	2/298 (0.7%)	2
Transient ischemic attack	0/326 (0%)	0	1/216 (0.5%)	1	1/298 (0.3%)	1
Other (Not Including Serious) Adverse Events
	Usual Care		Online Program Only		Combined Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/326 (0%)		0/216 (0%)		0/298 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.