Integrating Online Weight Management With Primary Care Support (PROPS)

• ClinicalTrials.gov Identifier: NCT02656693
• Recruitment Status: Completed
• First Posted: January 15, 2016
• Results First Posted: August 9, 2019
• Last Update Posted: November 5, 2020
• Sponsor: Brigham and Women's Hospital
• Collaborator: Patient-Centered Outcomes Research Institute
• Information provided by (Responsible Party): Heather J. Baer, Brigham and Women's Hospital

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Health Services Research
• Condition: Obesity
• Interventions: Behavioral: Online weight management program; Behavioral: Population health management support
• Enrollment: 840

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Usual Care	Online Program Only	Combined Intervention
Arm/Group Description	Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	Patients will use an online weight management program called BMIQ, with minimal additional support. Online weight management program: Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program.	Patients will use an online weight management program called BMIQ, but will also receive additional monitoring and support from a population health manager who works with their primary care practices. Online weight management program: Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program. Population health management support: Patients will receive weight-related population health management support from their primary care practice; their online weight management program data will be monitored by the population health manager, who will conduct outreach with patients at designated points according to the protocol.
Period Title: Overall Study
Started	326	216	298
Completed	325	214	295
Not Completed	1	2	3
Reason Not Completed
Pregnancy	1	1	1
Bariatric surgery	0	1	2

Baseline Characteristics

Arm/Group Title		Usual Care	Online Program Only	Combined Intervention	Total
Arm/Group Description		Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	Patients will use an online weight management program called BMIQ, with minimal additional support. Online weight management program: Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program.	Patients will use an online weight management program called BMIQ, but will also receive additional monitoring and support from a population health manager who works with their primary care practices. Online weight management program: Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program. Population health management support: Patients will receive weight-related population health management support from their primary care practice; their online weight management program data will be monitored by the population health manager, who will conduct outreach with patients at designated points according to the protocol.	Total of all reporting groups
Overall Number of Baseline Participants		326	216	298	840
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	326 participants	216 participants	298 participants	840 participants
		58.7 (8.6)	59.1 (8.8)	60.1 (8.3)	59.3 (8.6)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	326 participants	216 participants	298 participants	840 participants
	Female	217 66.6%	128 59.3%	159 53.4%	504 60.0%
	Male	109 33.4%	88 40.7%	139 46.6%	336 40.0%
Race/Ethnicity, Customized [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	326 participants	215 participants	295 participants	836 participants
	White, non-Hispanic	249 76.4%	169 78.6%	227 76.9%	645 77.2%
	Black, non-Hispanic	39 12.0%	23 10.7%	31 10.5%	93 11.1%
	Hispanic	24 7.4%	12 5.6%	20 6.8%	56 6.7%
	Other/multiple categories	14 4.3%	11 5.1%	17 5.8%	42 5.0%
		[1] Measure Analysis Population Description: The number analyzed differs from overall because missing data has been excluded from this table.
Weight; Mean (Standard Deviation); Unit of measure: Kgs
	Number Analyzed	326 participants	216 participants	298 participants	840 participants
		91.8 (14.4)	91.6 (14.4)	92.9 (13.8)	92.1 (14.3)
Height; Mean (Standard Deviation); Unit of measure: Centimeters
	Number Analyzed	326 participants	216 participants	298 participants	840 participants
		167.4 (9.4)	168.7 (9.9)	169.2 (9.9)	168.4 (9.9)
Body mass index; Mean (Standard Deviation); Unit of measure: Kg/m^2
	Number Analyzed	326 participants	216 participants	298 participants	840 participants
		32.7 (3.3)	32.2 (3.2)	32.4 (3.4)	32.5 (3.3)
Medical conditions; Measure Type: Count of Participants; Unit of measure: Participants
Hypertension	Number Analyzed	326 participants	216 participants	298 participants	840 participants
		312 95.7%	211 97.7%	287 96.3%	810 96.4%
Type 2 diabetes	Number Analyzed	326 participants	216 participants	298 participants	840 participants
		73 22.4%	49 22.7%	83 27.9%	205 24.4%
Hypercholesterolemia	Number Analyzed	326 participants	216 participants	298 participants	840 participants
		67 20.6%	60 27.8%	56 18.8%	183 21.8%
Obstructive sleep apnea	Number Analyzed	326 participants	216 participants	298 participants	840 participants
		53 16.3%	36 16.7%	56 18.8%	145 17.3%
Coronary heart disease/ atherosclerosis	Number Analyzed	326 participants	216 participants	298 participants	840 participants
		2 0.6%	1 0.5%	4 1.3%	7 0.8%
Non-alcoholic fatty liver disease	Number Analyzed	326 participants	216 participants	298 participants	840 participants
		1 0.3%	1 0.5%	3 1.0%	5 0.6%
Highest level of education [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	288 participants	192 participants	258 participants	738 participants
	High school graduate or less	23 8.0%	16 8.3%	14 5.4%	53 7.2%
	Some college	91 31.6%	45 23.4%	50 19.4%	186 25.2%
	College graduate	102 35.4%	66 34.4%	83 32.2%	251 34.0%
	Master's, doctorate, or professional degree	72 25.0%	65 33.9%	111 43.0%	248 33.6%
		[1] Measure Analysis Population Description: The number analyzed differs from overall because missing data has been excluded from this table.
Employment status [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	314 participants	213 participants	288 participants	815 participants
	Employed (full-time or part-time)	206 65.6%	139 65.3%	169 58.7%	514 63.1%
	Retired	63 20.1%	33 15.5%	65 22.6%	161 19.8%
	Other	45 14.3%	41 19.2%	54 18.8%	140 17.2%
		[1] Measure Analysis Population Description: The number analyzed differs from overall because missing data has been excluded from this table.
Health insurance; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	326 participants	216 participants	298 participants	840 participants
	Private	217 66.6%	141 65.3%	207 69.5%	565 67.3%
	Medicare	72 22.1%	50 23.1%	68 22.8%	190 22.6%
	Medicaid/VA	37 11.3%	25 11.6%	23 7.7%	85 10.1%
Any previous weight loss attempts [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	291 participants	188 participants	266 participants	745 participants
		269 92.4%	182 96.8%	236 88.7%	687 92.2%
		[1] Measure Analysis Population Description: The number analyzed differs from overall because missing data has been excluded from this table.
Motivation to lose weight [1]; Mean (Standard Deviation); Unit of measure: Scores on a scale
	Number Analyzed	326 participants	216 participants	298 participants	840 participants
		8.8 (1.1)	8.9 (1.1)	8.9 (1.1)	8.9 (1.1)
		[1] Measure Description: During the screening process, participants were asked about their motivation to lose weight in the next 6 months, using a 10-point Likert scale where 1= not at all motivated and 10= completely or extremely motivated. This simple measure has been used in previous studies and is associated with behavior change. Only patients who report their level of motivation to be 7 or higher were eligible to participate in the study.
Internet use [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	287 participants	191 participants	260 participants	738 participants
	</= Once per week	6 2.1%	2 1.0%	4 1.5%	12 1.6%
	Several times per week	14 4.9%	13 6.8%	8 3.1%	35 4.7%
	Once per day	23 8.0%	9 4.7%	14 5.4%	46 6.2%
	>/= Several times per day	244 85.0%	167 87.4%	234 90.0%	645 87.4%
		[1] Measure Analysis Population Description: The number analyzed differs from overall because missing data has been excluded from this table.
Primary language; Measure Type: Count of Participants; Unit of measure: Participants
English	Number Analyzed	326 participants	216 participants	298 participants	840 participants
		315 96.6%	212 98.1%	288 96.6%	815 97.0%
Spanish	Number Analyzed	326 participants	216 participants	298 participants	840 participants
		11 3.4%	4 1.9%	10 3.4%	25 3.0%
Use of GLP-1 receptor agonist of SGLT2 inhibitors; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	326 participants	216 participants	298 participants	840 participants
		1 0.3%	1 0.5%	5 1.7%	7 0.8%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Online Program Only	Combined Intervention
Arm/Group Description:	Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	Patients will use an online weight management program called BMIQ, with minimal additional support. Online weight management program: Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program.	Patients will use an online weight management program called BMIQ, but will also receive additional monitoring and support from a population health manager who works with their primary care practices. Online weight management program: Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program. Population health management support: Patients will receive weight-related population health management support from their primary care practice; their online weight management program data will be monitored by the population health manager, who will conduct outreach with patients at designated points according to the protocol.
Overall Number of Participants Analyzed	326	216	298
Mean (95% Confidence Interval); Unit of Measure: kilograms
	-1.2; (-2.1 to -0.3)	-1.9; (-2.6 to -1.1)	-3.1; (-3.7 to -2.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Online Program Only, Combined Intervention
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.00017
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Online Program Only	Combined Intervention
Arm/Group Description:	Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	Patients will use an online weight management program called BMIQ, with minimal additional support. Online weight management program: Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program.	Patients will use an online weight management program called BMIQ, but will also receive additional monitoring and support from a population health manager who works with their primary care practices. Online weight management program: Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program. Population health management support: Patients will receive weight-related population health management support from their primary care practice; their online weight management program data will be monitored by the population health manager, who will conduct outreach with patients at designated points according to the protocol.
Overall Number of Participants Analyzed	326	216	298
Mean (95% Confidence Interval); Unit of Measure: kilograms
	-1.0; (-1.9 to -0.1)	-2.1; (-2.8 to -1.5)	-2.9; (-3.5 to -2.3)

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Online Program Only	Combined Intervention
Arm/Group Description:	Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	Patients will use an online weight management program called BMIQ, with minimal additional support. Online weight management program: Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program.	Patients will use an online weight management program called BMIQ, but will also receive additional monitoring and support from a population health manager who works with their primary care practices. Online weight management program: Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program. Population health management support: Patients will receive weight-related population health management support from their primary care practice; their online weight management program data will be monitored by the population health manager, who will conduct outreach with patients at designated points according to the protocol.
Overall Number of Participants Analyzed	326	216	298
Mean (95% Confidence Interval); Unit of Measure: kilograms
	-1.9; (-2.8 to -1.0)	-1.1; (-2.0 to -0.3)	-2.8; (-3.5 to -2.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Online Program Only, Combined Intervention
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	< 0.001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Online Program Only	Combined Intervention
Arm/Group Description:	Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	Patients will use an online weight management program called BMIQ, with minimal additional support. Online weight management program: Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program.	Patients will use an online weight management program called BMIQ, but will also receive additional monitoring and support from a population health manager who works with their primary care practices. Online weight management program: Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program. Population health management support: Patients will receive weight-related population health management support from their primary care practice; their online weight management program data will be monitored by the population health manager, who will conduct outreach with patients at designated points according to the protocol.
Overall Number of Participants Analyzed	326	216	298
Mean (95% Confidence Interval); Unit of Measure: percentage of weight change
	-1.0; (-1.9 to 0.03)	-2.0; (-3.1 to -0.9)	-2.8; (-3.8 to -1.8)

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Online Program Only	Combined Intervention
Arm/Group Description:	Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	Patients will use an online weight management program called BMIQ, with minimal additional support. Online weight management program: Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program.	Patients will use an online weight management program called BMIQ, but will also receive additional monitoring and support from a population health manager who works with their primary care practices. Online weight management program: Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program. Population health management support: Patients will receive weight-related population health management support from their primary care practice; their online weight management program data will be monitored by the population health manager, who will conduct outreach with patients at designated points according to the protocol.
Overall Number of Participants Analyzed	326	216	298
Mean (95% Confidence Interval); Unit of Measure: percentage of weight change
	-1.4; (-2.3 to -0.6)	-1.9; (-2.8 to -1.0)	-3.0; (-3.8 to -2.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Online Program Only, Combined Intervention
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	< 0.001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Online Program Only	Combined Intervention
Arm/Group Description:	Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	Patients will use an online weight management program called BMIQ, with minimal additional support. Online weight management program: Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program.	Patients will use an online weight management program called BMIQ, but will also receive additional monitoring and support from a population health manager who works with their primary care practices. Online weight management program: Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program. Population health management support: Patients will receive weight-related population health management support from their primary care practice; their online weight management program data will be monitored by the population health manager, who will conduct outreach with patients at designated points according to the protocol.
Overall Number of Participants Analyzed	326	216	298
Mean (95% Confidence Interval); Unit of Measure: percentage of weight change
	-1.9; (-2.9 to -0.9)	-0.9; (-2.0 to 0.2)	-2.6; (-3.6 to -1.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Combined Intervention
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.01
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Online Program Only	Combined Intervention
Arm/Group Description:	Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	Patients will use an online weight management program called BMIQ, with minimal additional support. Online weight management program: Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program.	Patients will use an online weight management program called BMIQ, but will also receive additional monitoring and support from a population health manager who works with their primary care practices. Online weight management program: Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program. Population health management support: Patients will receive weight-related population health management support from their primary care practice; their online weight management program data will be monitored by the population health manager, who will conduct outreach with patients at designated points according to the protocol.
Overall Number of Participants Analyzed	326	216	298
Mean (95% Confidence Interval); Unit of Measure: percentage of patients
	13.4; (7.8 to 19.0)	22.1; (14.2 to 30.0)	29.5; (21.4 to 37.5)

8. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Online Program Only	Combined Intervention
Arm/Group Description:	Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	Patients will use an online weight management program called BMIQ, with minimal additional support. Online weight management program: Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program.	Patients will use an online weight management program called BMIQ, but will also receive additional monitoring and support from a population health manager who works with their primary care practices. Online weight management program: Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program. Population health management support: Patients will receive weight-related population health management support from their primary care practice; their online weight management program data will be monitored by the population health manager, who will conduct outreach with patients at designated points according to the protocol.
Overall Number of Participants Analyzed	326	216	298
Mean (95% Confidence Interval); Unit of Measure: percentage of patients
	14.9; (10.2 to 19.6)	20.8; (14.5 to 27.2)	32.3; (25.8 to 38.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Online Program Only, Combined Intervention
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]

9. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Online Program Only	Combined Intervention
Arm/Group Description:	Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	Patients will use an online weight management program called BMIQ, with minimal additional support. Online weight management program: Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program.	Patients will use an online weight management program called BMIQ, but will also receive additional monitoring and support from a population health manager who works with their primary care practices. Online weight management program: Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program. Population health management support: Patients will receive weight-related population health management support from their primary care practice; their online weight management program data will be monitored by the population health manager, who will conduct outreach with patients at designated points according to the protocol.
Overall Number of Participants Analyzed	326	216	298
Mean (95% Confidence Interval); Unit of Measure: percentage of patients
	20.9; (14.3 to 27.6)	19.9; (12.5 to 27.3)	31.3; (23.0 to 39.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Online Program Only, Combined Intervention
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.20
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]

10. Secondary Outcome

Title	Changes in Self-efficacy Around Weight Loss at 12 Months
Description	Changes in self-efficacy around weight loss at 12 months Self-efficacy will be assessed by asking patients to rate their confidence in their ability to lose weight on a scale from 1 ("not at all confident") to 10 ("very confident"). A rank of 1-7 reflects low self-efficacy, while 8-10 reflects high self-efficacy based on Bandura's theory of self-efficacy.
Time Frame	12 months after initial primary care visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Online Program Only	Combined Intervention
Arm/Group Description:	Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	Patients will use an online weight management program called BMIQ, with minimal additional support. Online weight management program: Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program.	Patients will use an online weight management program called BMIQ, but will also receive additional monitoring and support from a population health manager who works with their primary care practices. Online weight management program: Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program. Population health management support: Patients will receive weight-related population health management support from their primary care practice; their online weight management program data will be monitored by the population health manager, who will conduct outreach with patients at designated points according to the protocol.
Overall Number of Participants Analyzed	326	216	298
Mean (95% Confidence Interval); Unit of Measure: score on a scale
	-0.7; (-1.1 to -0.3)	-0.4; (-0.9 to 0.07)	0.5; (0.06 to 0.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Online Program Only, Combined Intervention
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]

11. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Online Program Only	Combined Intervention
Arm/Group Description:	Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	Patients will use an online weight management program called BMIQ, with minimal additional support. Online weight management program: Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program.	Patients will use an online weight management program called BMIQ, but will also receive additional monitoring and support from a population health manager who works with their primary care practices. Online weight management program: Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program. Population health management support: Patients will receive weight-related population health management support from their primary care practice; their online weight management program data will be monitored by the population health manager, who will conduct outreach with patients at designated points according to the protocol.
Overall Number of Participants Analyzed	326	216	298
Mean (95% Confidence Interval); Unit of Measure: mmHg
	-0.9; (-2.8 to 1.0)	-3.0; (-5.4 to -0.6)	-0.2; (-2.3 to 1.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Online Program Only, Combined Intervention
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.19
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]

12. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Online Program Only	Combined Intervention
Arm/Group Description:	Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	Patients will use an online weight management program called BMIQ, with minimal additional support. Online weight management program: Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program.	Patients will use an online weight management program called BMIQ, but will also receive additional monitoring and support from a population health manager who works with their primary care practices. Online weight management program: Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program. Population health management support: Patients will receive weight-related population health management support from their primary care practice; their online weight management program data will be monitored by the population health manager, who will conduct outreach with patients at designated points according to the protocol.
Overall Number of Participants Analyzed	326	216	298
Mean (95% Confidence Interval); Unit of Measure: mmHg
	-1.0; (-2.2 to 0.3)	-2.2; (-3.8 to -0.7)	-1.1; (-2.4 to 0.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Online Program Only, Combined Intervention
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.35
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]

13. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Online Program Only	Combined Intervention
Arm/Group Description:	Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	Patients will use an online weight management program called BMIQ, with minimal additional support. Online weight management program: Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program.	Patients will use an online weight management program called BMIQ, but will also receive additional monitoring and support from a population health manager who works with their primary care practices. Online weight management program: Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program. Population health management support: Patients will receive weight-related population health management support from their primary care practice; their online weight management program data will be monitored by the population health manager, who will conduct outreach with patients at designated points according to the protocol.
Overall Number of Participants Analyzed	326	216	298
Mean (95% Confidence Interval); Unit of Measure: mg/dL
	-7.5; (-13.2 to -1.8)	-6.3; (-13.4 to 0.9)	-6.8; (-12.4 to -1.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Online Program Only, Combined Intervention
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.20
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]

14. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Online Program Only	Combined Intervention
Arm/Group Description:	Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	Patients will use an online weight management program called BMIQ, with minimal additional support. Online weight management program: Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program.	Patients will use an online weight management program called BMIQ, but will also receive additional monitoring and support from a population health manager who works with their primary care practices. Online weight management program: Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program. Population health management support: Patients will receive weight-related population health management support from their primary care practice; their online weight management program data will be monitored by the population health manager, who will conduct outreach with patients at designated points according to the protocol.
Overall Number of Participants Analyzed	326	216	298
Mean (95% Confidence Interval); Unit of Measure: mg/dL
	-0.4; (-2.2 to 1.3)	0.6; (-1.8 to 3.1)	0.7; (-1.3 to 2.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Online Program Only, Combined Intervention
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.33
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]

15. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Online Program Only	Combined Intervention
Arm/Group Description:	Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	Patients will use an online weight management program called BMIQ, with minimal additional support. Online weight management program: Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program.	Patients will use an online weight management program called BMIQ, but will also receive additional monitoring and support from a population health manager who works with their primary care practices. Online weight management program: Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program. Population health management support: Patients will receive weight-related population health management support from their primary care practice; their online weight management program data will be monitored by the population health manager, who will conduct outreach with patients at designated points according to the protocol.
Overall Number of Participants Analyzed	326	216	298
Mean (95% Confidence Interval); Unit of Measure: mg/dL
	-5.4; (-10.1 to -0.7)	-3.7; (-9.2 to 1.8)	-5.8; (-10.3 to -1.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Online Program Only, Combined Intervention
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.43
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]

16. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Online Program Only	Combined Intervention
Arm/Group Description:	Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	Patients will use an online weight management program called BMIQ, with minimal additional support. Online weight management program: Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program.	Patients will use an online weight management program called BMIQ, but will also receive additional monitoring and support from a population health manager who works with their primary care practices. Online weight management program: Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program. Population health management support: Patients will receive weight-related population health management support from their primary care practice; their online weight management program data will be monitored by the population health manager, who will conduct outreach with patients at designated points according to the protocol.
Overall Number of Participants Analyzed	326	216	298
Mean (95% Confidence Interval); Unit of Measure: mg/dL
	-12.4; (-24.9 to 0.06)	-8.0; (-24.2 to 8.1)	-10.2; (-23.5 to 3.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Online Program Only, Combined Intervention
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.40
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]

17. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Online Program Only	Combined Intervention
Arm/Group Description:	Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	Patients will use an online weight management program called BMIQ, with minimal additional support. Online weight management program: Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program.	Patients will use an online weight management program called BMIQ, but will also receive additional monitoring and support from a population health manager who works with their primary care practices. Online weight management program: Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program. Population health management support: Patients will receive weight-related population health management support from their primary care practice; their online weight management program data will be monitored by the population health manager, who will conduct outreach with patients at designated points according to the protocol.
Overall Number of Participants Analyzed	326	216	298
Mean (95% Confidence Interval); Unit of Measure: % of HbA1c
	-0.02; (-0.1 to 0.1)	0.02; (-0.1 to 0.2)	-0.02; (-0.2 to 0.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Online Program Only, Combined Intervention
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.16
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]

18. Secondary Outcome

Title	Changes in Weight-related Quality of Life Assessed by the Impact of Weight on Quality of Life (IWQOL)-Lite Questionnaire
Description	Weight-related quality of life will be assessed using the Impact of Weight of Quality of Life (IWQOL)-Lite questionnare. The IWQOL-Lite is a brief, 31-item self-report measure that consists of scores on five scales (physical function, self-esteem, sexual life, public distress, and work) and a total score (sum of scale scores). Participants are asked to rate items with respect to the past week, with responses from "never true" to "always true". Total scores range from 0 (worst possible quality of life) to 100 (best possible quality of life).
Time Frame	12 months after the initial primary care visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Online Program Only	Combined Intervention
Arm/Group Description:	Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	Patients will use an online weight management program called BMIQ, with minimal additional support. Online weight management program: Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program.	Patients will use an online weight management program called BMIQ, but will also receive additional monitoring and support from a population health manager who works with their primary care practices. Online weight management program: Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program. Population health management support: Patients will receive weight-related population health management support from their primary care practice; their online weight management program data will be monitored by the population health manager, who will conduct outreach with patients at designated points according to the protocol.
Overall Number of Participants Analyzed	326	216	298
Mean (95% Confidence Interval); Unit of Measure: score on a scale
	5.4; (4.0 to 6.8)	4.8; (3.0 to 6.7)	5.8; (4.2 to 7.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Online Program Only, Combined Intervention
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.61
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]

19. Secondary Outcome

Title	Changes in Percentage of Patients Reporting Excellent/Very Good Health Status Assessed by Using a 5-point Scale Questionnaire From the 36-Item Short Form Health Survey(SF-36)
Description	Health status will be assessed using 5-point scale response to a single question from the SF-36, "In general, would you say that your health is...(1=Excellent, 2=Very Good, 3=Good, 4=Fair, 5=Poor"). A higher score indicates a worse outcome (5= poor health status).
Time Frame	12 months after the initial primary care visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Online Program Only	Combined Intervention
Arm/Group Description:	Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	Patients will use an online weight management program called BMIQ, with minimal additional support. Online weight management program: Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program.	Patients will use an online weight management program called BMIQ, but will also receive additional monitoring and support from a population health manager who works with their primary care practices. Online weight management program: Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program. Population health management support: Patients will receive weight-related population health management support from their primary care practice; their online weight management program data will be monitored by the population health manager, who will conduct outreach with patients at designated points according to the protocol.
Overall Number of Participants Analyzed	326	216	298
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of patients
	14.5; (6.0 to 23.1)	16.1; (4.8 to 27.4)	21.4; (12.7 to 30.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Online Program Only, Combined Intervention
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.61
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]

20. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Online Program Only	Combined Intervention
Arm/Group Description:	Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	Patients will use an online weight management program called BMIQ, with minimal additional support. Online weight management program: Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program.	Patients will use an online weight management program called BMIQ, but will also receive additional monitoring and support from a population health manager who works with their primary care practices. Online weight management program: Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program. Population health management support: Patients will receive weight-related population health management support from their primary care practice; their online weight management program data will be monitored by the population health manager, who will conduct outreach with patients at designated points according to the protocol.
Overall Number of Participants Analyzed	326	216	298
Mean (95% Confidence Interval); Unit of Measure: minutes/week
	5.7; (-1.3 to 12.7)	2.6; (-6.8 to 12.0)	3.5; (-3.7 to 10.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Online Program Only, Combined Intervention
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.46
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]

21. Secondary Outcome

Title	Changes in Diet, Specifically Fruits/Vegetables, as Measured by the PrimeScreen Questionnaire
Description	changes in diet, specifically fruits/vegetables as measured by the PrimeScreen questionnaire, a brief dietary screening tool.
Time Frame	12 months after the initial primary care visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Online Program Only	Combined Intervention
Arm/Group Description:	Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	Patients will use an online weight management program called BMIQ, with minimal additional support. Online weight management program: Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program.	Patients will use an online weight management program called BMIQ, but will also receive additional monitoring and support from a population health manager who works with their primary care practices. Online weight management program: Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program. Population health management support: Patients will receive weight-related population health management support from their primary care practice; their online weight management program data will be monitored by the population health manager, who will conduct outreach with patients at designated points according to the protocol.
Overall Number of Participants Analyzed	326	216	298
Mean (95% Confidence Interval); Unit of Measure: servings/day
	0.4; (0.2 to 0.6)	0.3; (0.04 to 0.7)	0.4; (0.2 to 0.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Online Program Only, Combined Intervention
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.68
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]

22. Secondary Outcome

Title	Changes in Diet, Specifically Whole Grains, as Measured by the PrimeScreen Questionnaire
Description	changes in diet, specifically whole grains as measured by the PrimeScreen questionnaire, a brief dietary screening tool.
Time Frame	12 months after the initial primary care visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Online Program Only	Combined Intervention
Arm/Group Description:	Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	Patients will use an online weight management program called BMIQ, with minimal additional support. Online weight management program: Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program.	Patients will use an online weight management program called BMIQ, but will also receive additional monitoring and support from a population health manager who works with their primary care practices. Online weight management program: Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program. Population health management support: Patients will receive weight-related population health management support from their primary care practice; their online weight management program data will be monitored by the population health manager, who will conduct outreach with patients at designated points according to the protocol.
Overall Number of Participants Analyzed	326	216	298
Mean (95% Confidence Interval); Unit of Measure: servings/day
	0.02; (-0.05 to 0.1)	0.03; (-0.07 to 0.1)	0.1; (0.01 to 0.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Online Program Only, Combined Intervention
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.54
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]

23. Secondary Outcome

Title	Changes in Diet, Specifically Sugar-sweetened Beverages, as Measured by the PrimeScreen Questionnaire
Description	changes in diet, specifically sugar-sweetened beverages as measured by the PrimeScreen questionnaire, a brief dietary screening tool.
Time Frame	12 months after the initial primary care visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Online Program Only	Combined Intervention
Arm/Group Description:	Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	Patients will use an online weight management program called BMIQ, with minimal additional support. Online weight management program: Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program.	Patients will use an online weight management program called BMIQ, but will also receive additional monitoring and support from a population health manager who works with their primary care practices. Online weight management program: Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program. Population health management support: Patients will receive weight-related population health management support from their primary care practice; their online weight management program data will be monitored by the population health manager, who will conduct outreach with patients at designated points according to the protocol.
Overall Number of Participants Analyzed	326	216	298
Mean (95% Confidence Interval); Unit of Measure: servings/day
	0.01; (-0.05 to 0.08)	-0.1; (-0.2 to 0.01)	-0.1; (-0.1 to 0.01)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Online Program Only, Combined Intervention
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.09
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]

24. Secondary Outcome

Title	Changes in Diet, Specifically Baked Products, as Measured by the PrimeScreen Questionnaire
Description	changes in diet, specifically baked products as measured by the PrimeScreen questionnaire, a brief dietary screening tool.
Time Frame	12 months after the initial primary care visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Online Program Only	Combined Intervention
Arm/Group Description:	Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	Patients will use an online weight management program called BMIQ, with minimal additional support. Online weight management program: Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program.	Patients will use an online weight management program called BMIQ, but will also receive additional monitoring and support from a population health manager who works with their primary care practices. Online weight management program: Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program. Population health management support: Patients will receive weight-related population health management support from their primary care practice; their online weight management program data will be monitored by the population health manager, who will conduct outreach with patients at designated points according to the protocol.
Overall Number of Participants Analyzed	326	216	298
Mean (95% Confidence Interval); Unit of Measure: servings/day
	-0.1; (-0.1 to -0.02)	-0.1; (-0.1 to 0.02)	-0.1; (-0.1 to -0.003)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Online Program Only, Combined Intervention
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.42
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]

25. Secondary Outcome

Title	Changes in Diet, Specifically Processed Meats, as Measured by the PrimeScreen Questionnaire
Description	changes in diet, specifically processed meats as measured by the PrimeScreen questionnaire, a brief dietary screening tool.
Time Frame	12 months after the initial primary care visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Online Program Only	Combined Intervention
Arm/Group Description:	Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	Patients will use an online weight management program called BMIQ, with minimal additional support. Online weight management program: Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program.	Patients will use an online weight management program called BMIQ, but will also receive additional monitoring and support from a population health manager who works with their primary care practices. Online weight management program: Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program. Population health management support: Patients will receive weight-related population health management support from their primary care practice; their online weight management program data will be monitored by the population health manager, who will conduct outreach with patients at designated points according to the protocol.
Overall Number of Participants Analyzed	326	216	298
Mean (95% Confidence Interval); Unit of Measure: servings/day
	-0.02; (-0.1 to 0.02)	-0.1; (-0.1 to -0.01)	-0.1; (-0.1 to -0.01)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Online Program Only, Combined Intervention
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.23
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]

26. Secondary Outcome

Title	Changes in Diet, Specifically Fried Foods, as Measured by the PrimeScreen Questionnaire
Description	changes in diet, specifically fried foods as measured by the PrimeScreen questionnaire, a brief dietary screening tool.
Time Frame	12 months after the initial primary care visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Online Program Only	Combined Intervention
Arm/Group Description:	Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)	Patients will use an online weight management program called BMIQ, with minimal additional support. Online weight management program: Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program.	Patients will use an online weight management program called BMIQ, but will also receive additional monitoring and support from a population health manager who works with their primary care practices. Online weight management program: Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program. Population health management support: Patients will receive weight-related population health management support from their primary care practice; their online weight management program data will be monitored by the population health manager, who will conduct outreach with patients at designated points according to the protocol.
Overall Number of Participants Analyzed	326	216	298
Mean (95% Confidence Interval); Unit of Measure: servings/day
	-0.03; (-0.1 to 0.01)	-0.02; (-0.1 to 0.03)	-0.1; (-0.1 to -0.02)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Online Program Only, Combined Intervention
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.20
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]

Adverse Events

Time Frame	Adverse event data were collected from the date of enrollment to 18 months (+/- 90 days) after enrollment in the study.
Adverse Event Reporting Description	Staff received "research notifications" via the electronic health record whenever enrolled patients were admitted to and/or seen in the Emergency Dept of any Partners-affiliated hospital. Participants were also encouraged to self-report any serious medical conditions. Cases were regularly reviewed by research staff and escalated to the Principal Investigator, co-investigators, and patients' PCPs, as needed. Adverse events were reported/documented per Partners IRB guidelines.
Arm/Group Title	Usual Care		Online Program Only		Combined Intervention
Arm/Group Description	Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)		Patients will use an online weight management program called BMIQ, with minimal additional support. Online weight management program: Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program.		Patients will use an online weight management program called BMIQ, but will also receive additional monitoring and support from a population health manager who works with their primary care practices. Online weight management program: Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program. Population health management support: Patients will receive weight-related population health management support from their primary care practice; their online weight management program data will be monitored by the population health manager, who will conduct outreach with patients at designated points according to the protocol.
All-Cause Mortality
	Usual Care		Online Program Only		Combined Intervention
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	0/326 (0.00%)		0/216 (0.00%)		1/298 (0.34%)
Serious Adverse Events
	Usual Care		Online Program Only		Combined Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/326 (3.68%)		11/216 (5.09%)		18/298 (6.04%)
Cardiac disorders
Angina †	0/326 (0.00%)	0	1/216 (0.46%)	1	0/298 (0.00%)	0
Coronary arteriogram †	0/326 (0.00%)	0	0/216 (0.00%)	0	1/298 (0.34%)	1
Coronary artery bypass grafting (CABG) †	1/326 (0.31%)	1	2/216 (0.93%)	2	0/298 (0.00%)	0
Dyspnea †	0/326 (0.00%)	0	0/216 (0.00%)	0	1/298 (0.34%)	1
Heart attack †	1/326 (0.31%)	1	2/216 (0.93%)	2	0/298 (0.00%)	0
Endocrine disorders
Pancreatitis †	0/326 (0.00%)	0	0/216 (0.00%)	0	2/298 (0.67%)	2
Gastrointestinal disorders
GI bleed †	1/326 (0.31%)	1	0/216 (0.00%)	0	1/298 (0.34%)	1
Infections and infestations
Endocarditis †	0/326 (0.00%)	0	0/216 (0.00%)	0	1/298 (0.34%)	1
Injury, poisoning and procedural complications
Fall †	0/326 (0.00%)	0	0/216 (0.00%)	0	1/298 (0.34%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer †	2/326 (0.61%)	2	0/216 (0.00%)	0	0/298 (0.00%)	0
Breast cancer †	3/326 (0.92%)	3	0/216 (0.00%)	0	3/298 (1.01%)	3
Endometrial cancer †	0/326 (0.00%)	0	0/216 (0.00%)	0	1/298 (0.34%)	1
Melanoma in situ †	1/326 (0.31%)	1	0/216 (0.00%)	0	0/298 (0.00%)	0
Prostate cancer †	1/326 (0.31%)	1	4/216 (1.85%)	4	1/298 (0.34%)	1
Squamous cell carcinoma †	0/326 (0.00%)	0	0/216 (0.00%)	0	1/298 (0.34%)	1
Nervous system disorders
Headache †	0/326 (0.00%)	0	0/216 (0.00%)	0	1/298 (0.34%)	1
Seizure †	1/326 (0.31%)	1	0/216 (0.00%)	0	0/298 (0.00%)	0
Psychiatric disorders
Alcohol use disorder †	0/326 (0.00%)	0	0/216 (0.00%)	0	1/298 (0.34%)	1
Depression †	0/326 (0.00%)	0	0/216 (0.00%)	0	1/298 (0.34%)	1
Surgical and medical procedures
Brain surgery †	0/326 (0.00%)	0	1/216 (0.46%)	1	0/298 (0.00%)	0
Spinal stenosis of lumbar region †	0/326 (0.00%)	0	1/216 (0.46%)	1	0/298 (0.00%)	0
Vascular disorders
Pulmonary embolism †	1/326 (0.31%)	1	1/216 (0.46%)	1	2/298 (0.67%)	2
Transient ischemic attack †	0/326 (0.00%)	0	1/216 (0.46%)	1	1/298 (0.34%)	1
† Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Usual Care		Online Program Only		Combined Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/326 (0.00%)		0/216 (0.00%)		0/298 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

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

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

Results Point of Contact

• Name/Title: Heather J. Baer, ScD
• Organization: Brigham and Women's Hospital
• Phone: 617-525-7503
• EMail: hbaer@bwh.harvard.edu

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Baer HJ, Rozenblum R, De La Cruz BA, Orav EJ, Wien M, Nolido NV, Metzler K, McManus KD, Halperin F, Aronne LJ, Minero G, Block JP, Bates DW. Effect of an Online Weight Management Program Integrated With Population Health Management on Weight Change: A Randomized Clinical Trial. JAMA. 2020 Nov 3;324(17):1737-1746. doi: 10.1001/jama.2020.18977.

Baer HJ, De La Cruz BA, Rozenblum R, Nolido NV, Orav EJ, Metzler K, Block JP, Halperin F, McManus KD, Aronne LJ, Minero G, Bates DW. Integrating an online weight management program with population health management in primary care: Design, methods, and baseline data from the PROPS randomized controlled trial (Partnerships for Reducing Overweight and Obesity with Patient-centered Strategies). Contemp Clin Trials. 2020 Aug;95:106026. doi: 10.1016/j.cct.2020.106026. Epub 2020 May 16.

Rozenblum R, De La Cruz BA, Nolido NV, Adighibe I, Secinaro K, McManus KD, Halperin F, Block JP, Bates DW, Baer HJ. Primary Care Patients' and Providers' Perspectives about an Online Weight Management Program: a Qualitative Study. J Gen Intern Med. 2019 Aug;34(8):1503-1521. doi: 10.1007/s11606-019-05022-6. Epub 2019 May 31.

• Responsible Party: Heather J. Baer, Brigham and Women's Hospital
• ClinicalTrials.gov Identifier: NCT02656693
• Other Study ID Numbers: 2015P002372
• First Submitted: January 4, 2016
• First Posted: January 15, 2016
• Results First Submitted: June 26, 2019
• Results First Posted: August 9, 2019
• Last Update Posted: November 5, 2020