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Integrating Online Weight Management With Primary Care Support (PROPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Usual Care Online Program Only Combined Intervention
Hide 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
Arm/Group Title Usual Care Online Program Only Combined Intervention Total
Hide 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
Hide 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%
1.Primary Outcome
Title Change in Body Weight at 12 Months
Hide Description change in body weight from enrollment to 12 months
Time Frame 12 months after the initial primary care visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Online Program Only Combined Intervention
Hide 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)
Hide 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
Hide Description change in body weight from enrollment to 6 months
Time Frame 6 months after the initial primary care visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Online Program Only Combined Intervention
Hide 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
Hide Description change in body weight from enrollment to 18 months
Time Frame 18 months after the initial primary care visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Online Program Only Combined Intervention
Hide 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)
Hide 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
Hide Description Percent weight change from enrollment to 6 months
Time Frame 6 months after the initial primary care visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Online Program Only Combined Intervention
Hide 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
Hide Description Percent weight change from enrollment to 12 months
Time Frame 12 months after the initial primary care visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Online Program Only Combined Intervention
Hide 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)
Hide 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
Hide Description Percent weight change from enrollment to 18 months
Time Frame 18 months after the initial primary care visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Online Program Only Combined Intervention
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Online Program Only Combined Intervention
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Online Program Only Combined Intervention
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Online Program Only Combined Intervention
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Online Program Only Combined Intervention
Hide 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)
Hide 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
Hide Description changes in systolic blood pressure (BP) from enrollment to 12 months
Time Frame 12 months after the initial primary care visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Online Program Only Combined Intervention
Hide 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)
Hide 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
Hide Description changes in diastolic blood pressure (BP) from enrollment to 12 months
Time Frame 12 months after the initial primary care visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Online Program Only Combined Intervention
Hide 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)
Hide 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
Hide Description changes in total cholesterol from Enrollment to 12 Months
Time Frame 12 months after the initial primary care visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Online Program Only Combined Intervention
Hide 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)
Hide 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
Hide Description changes in HDL cholesterol from Enrollment to 12 Months
Time Frame 12 months after the initial primary care visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Online Program Only Combined Intervention
Hide 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)
Hide 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
Hide Description changes in LDL cholesterol from Enrollment to 12 Months
Time Frame 12 months after the initial primary care visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Online Program Only Combined Intervention
Hide 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)
Hide 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
Hide Description changes in triglycerides from enrollment to 12 months
Time Frame 12 months after the initial primary care visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Online Program Only Combined Intervention
Hide 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)
Hide 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
Hide Description changes in Hemoglobin (HbA1c) levels from enrollment to 12 months
Time Frame 12 months after the initial primary care visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Online Program Only Combined Intervention
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Online Program Only Combined Intervention
Hide 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)
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Online Program Only Combined Intervention
Hide 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)
Hide 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
Hide Description changes in self-reported physical activity minutes per week
Time Frame 12 months after the initial primary care visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Online Program Only Combined Intervention
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Online Program Only Combined Intervention
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Online Program Only Combined Intervention
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Online Program Only Combined Intervention
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Online Program Only Combined Intervention
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Online Program Only Combined Intervention
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Online Program Only Combined Intervention
Hide 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)
Hide 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]
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
Hide 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%)    
Hide 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
Hide 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%)    
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
Layout table for Results Point of Contact information
Name/Title: Heather J. Baer, ScD
Organization: Brigham and Women's Hospital
Phone: 617-525-7503
EMail: hbaer@bwh.harvard.edu
Layout table for additonal information
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