Trial Outcomes & Findings for Integrating Online Weight Management With Primary Care Support (NCT NCT02656693)

NCT ID: NCT02656693

Last Updated: 2020-11-05

Results Overview

change in body weight from enrollment to 12 months

Recruitment status

COMPLETED

Study phase

Target enrollment

840 participants

Primary outcome timeframe

12 months after the initial primary care visit

Results posted on

2020-11-05

Participant Flow

Participant milestones

Participant milestones
Measure	Usual Care Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	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.	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.
Overall Study STARTED	326	216	298
Overall Study COMPLETED	325	214	295
Overall Study NOT COMPLETED	1	2	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Usual Care Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	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.	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.
Overall Study Pregnancy	1	1	1
Overall Study Bariatric surgery	0	1	2

Baseline Characteristics

The number analyzed differs from overall because missing data has been excluded from this table.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Usual Care n=326 Participants Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	Online Program Only n=216 Participants 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.	Combined Intervention n=298 Participants 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 n=840 Participants Total of all reporting groups
Age, Continuous	58.7 years STANDARD_DEVIATION 8.6 • n=326 Participants	59.1 years STANDARD_DEVIATION 8.8 • n=216 Participants	60.1 years STANDARD_DEVIATION 8.3 • n=298 Participants	59.3 years STANDARD_DEVIATION 8.6 • n=840 Participants
Sex: Female, Male Female	217 Participants n=326 Participants	128 Participants n=216 Participants	159 Participants n=298 Participants	504 Participants n=840 Participants
Sex: Female, Male Male	109 Participants n=326 Participants	88 Participants n=216 Participants	139 Participants n=298 Participants	336 Participants n=840 Participants
Race/Ethnicity, Customized White, non-Hispanic	249 Participants n=326 Participants • The number analyzed differs from overall because missing data has been excluded from this table.	169 Participants n=215 Participants • The number analyzed differs from overall because missing data has been excluded from this table.	227 Participants n=295 Participants • The number analyzed differs from overall because missing data has been excluded from this table.	645 Participants n=836 Participants • The number analyzed differs from overall because missing data has been excluded from this table.
Race/Ethnicity, Customized Black, non-Hispanic	39 Participants n=326 Participants • The number analyzed differs from overall because missing data has been excluded from this table.	23 Participants n=215 Participants • The number analyzed differs from overall because missing data has been excluded from this table.	31 Participants n=295 Participants • The number analyzed differs from overall because missing data has been excluded from this table.	93 Participants n=836 Participants • The number analyzed differs from overall because missing data has been excluded from this table.
Race/Ethnicity, Customized Hispanic	24 Participants n=326 Participants • The number analyzed differs from overall because missing data has been excluded from this table.	12 Participants n=215 Participants • The number analyzed differs from overall because missing data has been excluded from this table.	20 Participants n=295 Participants • The number analyzed differs from overall because missing data has been excluded from this table.	56 Participants n=836 Participants • The number analyzed differs from overall because missing data has been excluded from this table.
Race/Ethnicity, Customized Other/multiple categories	14 Participants n=326 Participants • The number analyzed differs from overall because missing data has been excluded from this table.	11 Participants n=215 Participants • The number analyzed differs from overall because missing data has been excluded from this table.	17 Participants n=295 Participants • The number analyzed differs from overall because missing data has been excluded from this table.	42 Participants n=836 Participants • The number analyzed differs from overall because missing data has been excluded from this table.
Weight	91.8 kgs STANDARD_DEVIATION 14.4 • n=326 Participants	91.6 kgs STANDARD_DEVIATION 14.4 • n=216 Participants	92.9 kgs STANDARD_DEVIATION 13.8 • n=298 Participants	92.1 kgs STANDARD_DEVIATION 14.3 • n=840 Participants
Height	167.4 centimeters STANDARD_DEVIATION 9.4 • n=326 Participants	168.7 centimeters STANDARD_DEVIATION 9.9 • n=216 Participants	169.2 centimeters STANDARD_DEVIATION 9.9 • n=298 Participants	168.4 centimeters STANDARD_DEVIATION 9.9 • n=840 Participants
Body mass index	32.7 kg/m^2 STANDARD_DEVIATION 3.3 • n=326 Participants	32.2 kg/m^2 STANDARD_DEVIATION 3.2 • n=216 Participants	32.4 kg/m^2 STANDARD_DEVIATION 3.4 • n=298 Participants	32.5 kg/m^2 STANDARD_DEVIATION 3.3 • n=840 Participants
Medical conditions Hypertension	312 Participants n=326 Participants	211 Participants n=216 Participants	287 Participants n=298 Participants	810 Participants n=840 Participants
Medical conditions Type 2 diabetes	73 Participants n=326 Participants	49 Participants n=216 Participants	83 Participants n=298 Participants	205 Participants n=840 Participants
Medical conditions Hypercholesterolemia	67 Participants n=326 Participants	60 Participants n=216 Participants	56 Participants n=298 Participants	183 Participants n=840 Participants
Medical conditions Obstructive sleep apnea	53 Participants n=326 Participants	36 Participants n=216 Participants	56 Participants n=298 Participants	145 Participants n=840 Participants
Medical conditions Coronary heart disease/ atherosclerosis	2 Participants n=326 Participants	1 Participants n=216 Participants	4 Participants n=298 Participants	7 Participants n=840 Participants
Medical conditions Non-alcoholic fatty liver disease	1 Participants n=326 Participants	1 Participants n=216 Participants	3 Participants n=298 Participants	5 Participants n=840 Participants
Highest level of education High school graduate or less	23 Participants n=288 Participants • The number analyzed differs from overall because missing data has been excluded from this table.	16 Participants n=192 Participants • The number analyzed differs from overall because missing data has been excluded from this table.	14 Participants n=258 Participants • The number analyzed differs from overall because missing data has been excluded from this table.	53 Participants n=738 Participants • The number analyzed differs from overall because missing data has been excluded from this table.
Highest level of education Some college	91 Participants n=288 Participants • The number analyzed differs from overall because missing data has been excluded from this table.	45 Participants n=192 Participants • The number analyzed differs from overall because missing data has been excluded from this table.	50 Participants n=258 Participants • The number analyzed differs from overall because missing data has been excluded from this table.	186 Participants n=738 Participants • The number analyzed differs from overall because missing data has been excluded from this table.
Highest level of education College graduate	102 Participants n=288 Participants • The number analyzed differs from overall because missing data has been excluded from this table.	66 Participants n=192 Participants • The number analyzed differs from overall because missing data has been excluded from this table.	83 Participants n=258 Participants • The number analyzed differs from overall because missing data has been excluded from this table.	251 Participants n=738 Participants • The number analyzed differs from overall because missing data has been excluded from this table.
Highest level of education Master's, doctorate, or professional degree	72 Participants n=288 Participants • The number analyzed differs from overall because missing data has been excluded from this table.	65 Participants n=192 Participants • The number analyzed differs from overall because missing data has been excluded from this table.	111 Participants n=258 Participants • The number analyzed differs from overall because missing data has been excluded from this table.	248 Participants n=738 Participants • The number analyzed differs from overall because missing data has been excluded from this table.
Employment status Employed (full-time or part-time)	206 Participants n=314 Participants • The number analyzed differs from overall because missing data has been excluded from this table.	139 Participants n=213 Participants • The number analyzed differs from overall because missing data has been excluded from this table.	169 Participants n=288 Participants • The number analyzed differs from overall because missing data has been excluded from this table.	514 Participants n=815 Participants • The number analyzed differs from overall because missing data has been excluded from this table.
Employment status Retired	63 Participants n=314 Participants • The number analyzed differs from overall because missing data has been excluded from this table.	33 Participants n=213 Participants • The number analyzed differs from overall because missing data has been excluded from this table.	65 Participants n=288 Participants • The number analyzed differs from overall because missing data has been excluded from this table.	161 Participants n=815 Participants • The number analyzed differs from overall because missing data has been excluded from this table.
Employment status Other	45 Participants n=314 Participants • The number analyzed differs from overall because missing data has been excluded from this table.	41 Participants n=213 Participants • The number analyzed differs from overall because missing data has been excluded from this table.	54 Participants n=288 Participants • The number analyzed differs from overall because missing data has been excluded from this table.	140 Participants n=815 Participants • The number analyzed differs from overall because missing data has been excluded from this table.
Health insurance Private	217 Participants n=326 Participants	141 Participants n=216 Participants	207 Participants n=298 Participants	565 Participants n=840 Participants
Health insurance Medicare	72 Participants n=326 Participants	50 Participants n=216 Participants	68 Participants n=298 Participants	190 Participants n=840 Participants
Health insurance Medicaid/VA	37 Participants n=326 Participants	25 Participants n=216 Participants	23 Participants n=298 Participants	85 Participants n=840 Participants
Any previous weight loss attempts	269 Participants n=291 Participants • The number analyzed differs from overall because missing data has been excluded from this table.	182 Participants n=188 Participants • The number analyzed differs from overall because missing data has been excluded from this table.	236 Participants n=266 Participants • The number analyzed differs from overall because missing data has been excluded from this table.	687 Participants n=745 Participants • The number analyzed differs from overall because missing data has been excluded from this table.
Motivation to lose weight	8.8 scores on a scale STANDARD_DEVIATION 1.1 • n=326 Participants	8.9 scores on a scale STANDARD_DEVIATION 1.1 • n=216 Participants	8.9 scores on a scale STANDARD_DEVIATION 1.1 • n=298 Participants	8.9 scores on a scale STANDARD_DEVIATION 1.1 • n=840 Participants
Internet use </= Once per week	6 Participants n=287 Participants • The number analyzed differs from overall because missing data has been excluded from this table.	2 Participants n=191 Participants • The number analyzed differs from overall because missing data has been excluded from this table.	4 Participants n=260 Participants • The number analyzed differs from overall because missing data has been excluded from this table.	12 Participants n=738 Participants • The number analyzed differs from overall because missing data has been excluded from this table.
Internet use Several times per week	14 Participants n=287 Participants • The number analyzed differs from overall because missing data has been excluded from this table.	13 Participants n=191 Participants • The number analyzed differs from overall because missing data has been excluded from this table.	8 Participants n=260 Participants • The number analyzed differs from overall because missing data has been excluded from this table.	35 Participants n=738 Participants • The number analyzed differs from overall because missing data has been excluded from this table.
Internet use Once per day	23 Participants n=287 Participants • The number analyzed differs from overall because missing data has been excluded from this table.	9 Participants n=191 Participants • The number analyzed differs from overall because missing data has been excluded from this table.	14 Participants n=260 Participants • The number analyzed differs from overall because missing data has been excluded from this table.	46 Participants n=738 Participants • The number analyzed differs from overall because missing data has been excluded from this table.
Internet use >/= Several times per day	244 Participants n=287 Participants • The number analyzed differs from overall because missing data has been excluded from this table.	167 Participants n=191 Participants • The number analyzed differs from overall because missing data has been excluded from this table.	234 Participants n=260 Participants • The number analyzed differs from overall because missing data has been excluded from this table.	645 Participants n=738 Participants • The number analyzed differs from overall because missing data has been excluded from this table.
Primary language English	315 Participants n=326 Participants	212 Participants n=216 Participants	288 Participants n=298 Participants	815 Participants n=840 Participants
Primary language Spanish	11 Participants n=326 Participants	4 Participants n=216 Participants	10 Participants n=298 Participants	25 Participants n=840 Participants
Use of GLP-1 receptor agonist of SGLT2 inhibitors	1 Participants n=326 Participants	1 Participants n=216 Participants	5 Participants n=298 Participants	7 Participants n=840 Participants

PRIMARY outcome

Timeframe: 12 months after the initial primary care visit

change in body weight from enrollment to 12 months

Outcome measures

Outcome measures
Measure	Usual Care n=326 Participants Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	Online Program Only n=216 Participants 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.	Combined Intervention n=298 Participants 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.
Change in Body Weight at 12 Months	-1.2 kilograms Interval -2.1 to -0.3	-1.9 kilograms Interval -2.6 to -1.1	-3.1 kilograms Interval -3.7 to -2.5

SECONDARY outcome

Timeframe: 6 months after the initial primary care visit

change in body weight from enrollment to 6 months

Outcome measures

Outcome measures
Measure	Usual Care n=326 Participants Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	Online Program Only n=216 Participants 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.	Combined Intervention n=298 Participants 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.
Change in Body Weight at 6 Months	-1.0 kilograms Interval -1.9 to -0.1	-2.1 kilograms Interval -2.8 to -1.5	-2.9 kilograms Interval -3.5 to -2.3

SECONDARY outcome

Timeframe: 18 months after the initial primary care visit

change in body weight from enrollment to 18 months

Outcome measures

Outcome measures
Measure	Usual Care n=326 Participants Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	Online Program Only n=216 Participants 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.	Combined Intervention n=298 Participants 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.
Change in Body Weight at 18 Months	-1.9 kilograms Interval -2.8 to -1.0	-1.1 kilograms Interval -2.0 to -0.3	-2.8 kilograms Interval -3.5 to -2.0

SECONDARY outcome

Timeframe: 6 months after the initial primary care visit

Percent weight change from enrollment to 6 months

Outcome measures

Outcome measures
Measure	Usual Care n=326 Participants Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	Online Program Only n=216 Participants 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.	Combined Intervention n=298 Participants 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.
Percent Weight Change at 6 Months	-1.0 percentage of weight change Interval -1.9 to 0.03	-2.0 percentage of weight change Interval -3.1 to -0.9	-2.8 percentage of weight change Interval -3.8 to -1.8

SECONDARY outcome

Timeframe: 12 months after the initial primary care visit

Percent weight change from enrollment to 12 months

Outcome measures

Outcome measures
Measure	Usual Care n=326 Participants Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	Online Program Only n=216 Participants 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.	Combined Intervention n=298 Participants 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.
Percent Weight Change at 12-Months	-1.4 percentage of weight change Interval -2.3 to -0.6	-1.9 percentage of weight change Interval -2.8 to -1.0	-3.0 percentage of weight change Interval -3.8 to -2.1

SECONDARY outcome

Timeframe: 18 months after the initial primary care visit

Percent weight change from enrollment to 18 months

Outcome measures

Outcome measures
Measure	Usual Care n=326 Participants Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	Online Program Only n=216 Participants 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.	Combined Intervention n=298 Participants 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.
Percent Weight Change at 18-Months	-1.9 percentage of weight change Interval -2.9 to -0.9	-0.9 percentage of weight change Interval -2.0 to 0.2	-2.6 percentage of weight change Interval -3.6 to -1.5

SECONDARY outcome

Timeframe: 6-months after the initial primary care visit

Percent of Patients With at Least 5% Weight Loss from enrollment to 6 months

Outcome measures

Outcome measures
Measure	Usual Care n=326 Participants Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	Online Program Only n=216 Participants 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.	Combined Intervention n=298 Participants 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.
Percent of Patients With at Least 5% Weight Loss at 6 Months	13.4 percentage of patients Interval 7.8 to 19.0	22.1 percentage of patients Interval 14.2 to 30.0	29.5 percentage of patients Interval 21.4 to 37.5

SECONDARY outcome

Timeframe: 12 months after the initial primary care visit

Percent of Patients with at least 5% weight loss from enrollment to 12 months

Outcome measures

Outcome measures
Measure	Usual Care n=326 Participants Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	Online Program Only n=216 Participants 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.	Combined Intervention n=298 Participants 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.
Percent of Patients With at Least 5% Weight Loss at 12-months	14.9 percentage of patients Interval 10.2 to 19.6	20.8 percentage of patients Interval 14.5 to 27.2	32.3 percentage of patients Interval 25.8 to 38.8

SECONDARY outcome

Timeframe: 18-months after the initial primary care visit

Percent of Patients With at least 5% weight loss from enrollment to 18 months

Outcome measures

Outcome measures
Measure	Usual Care n=326 Participants Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	Online Program Only n=216 Participants 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.	Combined Intervention n=298 Participants 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.
Percent of Patients With at Least 5% Weight Loss at 18 Months	20.9 percentage of patients Interval 14.3 to 27.6	19.9 percentage of patients Interval 12.5 to 27.3	31.3 percentage of patients Interval 23.0 to 39.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Usual Care n=326 Participants Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	Online Program Only n=216 Participants 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.	Combined Intervention n=298 Participants 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.
Changes in Self-efficacy Around Weight Loss at 12 Months	-0.7 score on a scale Interval -1.1 to -0.3	-0.4 score on a scale Interval -0.9 to 0.07	0.5 score on a scale Interval 0.06 to 0.9

SECONDARY outcome

Timeframe: 12 months after the initial primary care visit

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

Outcome measures

Outcome measures
Measure	Usual Care n=326 Participants Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	Online Program Only n=216 Participants 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.	Combined Intervention n=298 Participants 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.
Changes in Systolic Blood Pressure	-0.9 mmHg Interval -2.8 to 1.0	-3.0 mmHg Interval -5.4 to -0.6	-0.2 mmHg Interval -2.3 to 1.9

SECONDARY outcome

Timeframe: 12 months after the initial primary care visit

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

Outcome measures

Outcome measures
Measure	Usual Care n=326 Participants Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	Online Program Only n=216 Participants 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.	Combined Intervention n=298 Participants 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.
Changes in Diastolic Blood Pressure	-1.0 mmHg Interval -2.2 to 0.3	-2.2 mmHg Interval -3.8 to -0.7	-1.1 mmHg Interval -2.4 to 0.2

SECONDARY outcome

Timeframe: 12 months after the initial primary care visit

changes in total cholesterol from Enrollment to 12 Months

Outcome measures

Outcome measures
Measure	Usual Care n=326 Participants Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	Online Program Only n=216 Participants 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.	Combined Intervention n=298 Participants 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.
Changes in Total Cholesterol	-7.5 mg/dL Interval -13.2 to -1.8	-6.3 mg/dL Interval -13.4 to 0.9	-6.8 mg/dL Interval -12.4 to -1.1

SECONDARY outcome

Timeframe: 12 months after the initial primary care visit

changes in HDL cholesterol from Enrollment to 12 Months

Outcome measures

Outcome measures
Measure	Usual Care n=326 Participants Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	Online Program Only n=216 Participants 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.	Combined Intervention n=298 Participants 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.
Changes in HDL Cholesterol	-0.4 mg/dL Interval -2.2 to 1.3	0.6 mg/dL Interval -1.8 to 3.1	0.7 mg/dL Interval -1.3 to 2.7

SECONDARY outcome

Timeframe: 12 months after the initial primary care visit

changes in LDL cholesterol from Enrollment to 12 Months

Outcome measures

Outcome measures
Measure	Usual Care n=326 Participants Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	Online Program Only n=216 Participants 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.	Combined Intervention n=298 Participants 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.
Changes in LDL Cholesterol	-5.4 mg/dL Interval -10.1 to -0.7	-3.7 mg/dL Interval -9.2 to 1.8	-5.8 mg/dL Interval -10.3 to -1.2

SECONDARY outcome

Timeframe: 12 months after the initial primary care visit

changes in triglycerides from enrollment to 12 months

Outcome measures

Outcome measures
Measure	Usual Care n=326 Participants Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	Online Program Only n=216 Participants 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.	Combined Intervention n=298 Participants 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.
Changes in Triglycerides	-12.4 mg/dL Interval -24.9 to 0.06	-8.0 mg/dL Interval -24.2 to 8.1	-10.2 mg/dL Interval -23.5 to 3.1

SECONDARY outcome

Timeframe: 12 months after the initial primary care visit

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

Outcome measures

Outcome measures
Measure	Usual Care n=326 Participants Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	Online Program Only n=216 Participants 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.	Combined Intervention n=298 Participants 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.
Changes in HbA1c Levels	-0.02 % of HbA1c Interval -0.1 to 0.1	0.02 % of HbA1c Interval -0.1 to 0.2	-0.02 % of HbA1c Interval -0.2 to 0.1

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Usual Care n=326 Participants Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	Online Program Only n=216 Participants 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.	Combined Intervention n=298 Participants 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.
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 Interval 4.0 to 6.8	4.8 score on a scale Interval 3.0 to 6.7	5.8 score on a scale Interval 4.2 to 7.4

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Usual Care n=326 Participants Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	Online Program Only n=216 Participants 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.	Combined Intervention n=298 Participants 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.
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 Interval 6.0 to 23.1	16.1 percentage of patients Interval 4.8 to 27.4	21.4 percentage of patients Interval 12.7 to 30.0

SECONDARY outcome

Timeframe: 12 months after the initial primary care visit

changes in self-reported physical activity minutes per week

Outcome measures

Outcome measures
Measure	Usual Care n=326 Participants Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	Online Program Only n=216 Participants 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.	Combined Intervention n=298 Participants 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.
Changes in Self-reported Physical Activity	5.7 minutes/week Interval -1.3 to 12.7	2.6 minutes/week Interval -6.8 to 12.0	3.5 minutes/week Interval -3.7 to 10.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Usual Care n=326 Participants Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	Online Program Only n=216 Participants 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.	Combined Intervention n=298 Participants 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.
Changes in Diet, Specifically Fruits/Vegetables, as Measured by the PrimeScreen Questionnaire	0.4 servings/day Interval 0.2 to 0.6	0.3 servings/day Interval 0.04 to 0.7	0.4 servings/day Interval 0.2 to 0.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Usual Care n=326 Participants Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	Online Program Only n=216 Participants 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.	Combined Intervention n=298 Participants 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.
Changes in Diet, Specifically Whole Grains, as Measured by the PrimeScreen Questionnaire	0.02 servings/day Interval -0.05 to 0.1	0.03 servings/day Interval -0.07 to 0.1	0.1 servings/day Interval 0.01 to 0.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Usual Care n=326 Participants Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	Online Program Only n=216 Participants 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.	Combined Intervention n=298 Participants 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.
Changes in Diet, Specifically Sugar-sweetened Beverages, as Measured by the PrimeScreen Questionnaire	0.01 servings/day Interval -0.05 to 0.08	-0.1 servings/day Interval -0.2 to 0.01	-0.1 servings/day Interval -0.1 to 0.01

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Usual Care n=326 Participants Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	Online Program Only n=216 Participants 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.	Combined Intervention n=298 Participants 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.
Changes in Diet, Specifically Baked Products, as Measured by the PrimeScreen Questionnaire	-0.1 servings/day Interval -0.1 to -0.02	-0.1 servings/day Interval -0.1 to 0.02	-0.1 servings/day Interval -0.1 to -0.003

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Usual Care n=326 Participants Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	Online Program Only n=216 Participants 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.	Combined Intervention n=298 Participants 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.
Changes in Diet, Specifically Processed Meats, as Measured by the PrimeScreen Questionnaire	-0.02 servings/day Interval -0.1 to 0.02	-0.1 servings/day Interval -0.1 to -0.01	-0.1 servings/day Interval -0.1 to -0.01

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Usual Care n=326 Participants Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	Online Program Only n=216 Participants 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.	Combined Intervention n=298 Participants 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.
Changes in Diet, Specifically Fried Foods, as Measured by the PrimeScreen Questionnaire	-0.03 servings/day Interval -0.1 to 0.01	-0.02 servings/day Interval -0.1 to 0.03	-0.1 servings/day Interval -0.1 to -0.02

Adverse Events

Usual Care

Serious events: 12 serious events

Other events: 0 other events

Deaths: 0 deaths

Online Program Only

Serious events: 11 serious events

Other events: 0 other events

Deaths: 0 deaths

Combined Intervention

Serious events: 18 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Adverse event data not reported

Additional Information

Heather J. Baer, ScD

Brigham and Women's Hospital

Phone: 617-525-7503

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Usual Care n=326 participants at risk Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	Online Program Only n=216 participants at risk 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.	Combined Intervention n=298 participants at risk 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.
Cardiac disorders Angina	0.00% 0/326 • Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study. Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.	0.46% 1/216 • Number of events 1 • Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study. Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.	0.00% 0/298 • Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study. Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.
Cardiac disorders Coronary arteriogram	0.00% 0/326 • Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study. Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.	0.00% 0/216 • Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study. Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.	0.34% 1/298 • Number of events 1 • Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study. Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.
Cardiac disorders Coronary artery bypass grafting (CABG)	0.31% 1/326 • Number of events 1 • Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study. Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.	0.93% 2/216 • Number of events 2 • Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study. Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.	0.00% 0/298 • Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study. Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.
Cardiac disorders Dyspnea	0.00% 0/326 • Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study. Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.	0.00% 0/216 • Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study. Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.	0.34% 1/298 • Number of events 1 • Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study. Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.
Cardiac disorders Heart attack	0.31% 1/326 • Number of events 1 • Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study. Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.	0.93% 2/216 • Number of events 2 • Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study. Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.	0.00% 0/298 • Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study. Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.
Endocrine disorders Pancreatitis	0.00% 0/326 • Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study. Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.	0.00% 0/216 • Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study. Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.	0.67% 2/298 • Number of events 2 • Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study. Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.
Gastrointestinal disorders GI bleed	0.31% 1/326 • Number of events 1 • Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study. Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.	0.00% 0/216 • Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study. Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.	0.34% 1/298 • Number of events 1 • Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study. Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.
Infections and infestations Endocarditis	0.00% 0/326 • Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study. Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.	0.00% 0/216 • Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study. Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.	0.34% 1/298 • Number of events 1 • Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study. Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.
Injury, poisoning and procedural complications Fall	0.00% 0/326 • Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study. Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.	0.00% 0/216 • Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study. Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.	0.34% 1/298 • Number of events 1 • Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study. Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.61% 2/326 • Number of events 2 • Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study. Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.	0.00% 0/216 • Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study. Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.	0.00% 0/298 • Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study. Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.92% 3/326 • Number of events 3 • Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study. Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.	0.00% 0/216 • Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study. Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.	1.0% 3/298 • Number of events 3 • Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study. Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer	0.00% 0/326 • Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study. Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.	0.00% 0/216 • Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study. Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.	0.34% 1/298 • Number of events 1 • Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study. Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanoma in situ	0.31% 1/326 • Number of events 1 • Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study. Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.	0.00% 0/216 • Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study. Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.	0.00% 0/298 • Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study. Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.31% 1/326 • Number of events 1 • Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study. Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.	1.9% 4/216 • Number of events 4 • Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study. Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.	0.34% 1/298 • Number of events 1 • Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study. Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/326 • Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study. Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.	0.00% 0/216 • Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study. Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.	0.34% 1/298 • Number of events 1 • Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study. Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.
Nervous system disorders Headache	0.00% 0/326 • Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study. Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.	0.00% 0/216 • Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study. Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.	0.34% 1/298 • Number of events 1 • Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study. Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.
Nervous system disorders Seizure	0.31% 1/326 • Number of events 1 • Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study. Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.	0.00% 0/216 • Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study. Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.	0.00% 0/298 • Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study. Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.
Psychiatric disorders Alcohol use disorder	0.00% 0/326 • Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study. Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.	0.00% 0/216 • Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study. Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.	0.34% 1/298 • Number of events 1 • Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study. Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.
Psychiatric disorders Depression	0.00% 0/326 • Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study. Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.	0.00% 0/216 • Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study. Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.	0.34% 1/298 • Number of events 1 • Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study. Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.
Surgical and medical procedures Brain surgery	0.00% 0/326 • Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study. Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.	0.46% 1/216 • Number of events 1 • Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study. Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.	0.00% 0/298 • Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study. Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.
Surgical and medical procedures Spinal stenosis of lumbar region	0.00% 0/326 • Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study. Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.	0.46% 1/216 • Number of events 1 • Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study. Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.	0.00% 0/298 • Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study. Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.
Vascular disorders Pulmonary embolism	0.31% 1/326 • Number of events 1 • Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study. Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.	0.46% 1/216 • Number of events 1 • Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study. Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.	0.67% 2/298 • Number of events 2 • Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study. Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.
Vascular disorders Transient ischemic attack	0.00% 0/326 • Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study. Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.	0.46% 1/216 • Number of events 1 • Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study. Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.	0.34% 1/298 • Number of events 1 • Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study. Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.