Trial Outcomes & Findings for The EMBER Trial for Weight Management Engagement (NCT NCT05424081)
NCT ID: NCT05424081
Last Updated: 2026-05-22
Results Overview
Dichotomous variable representing whether participant has 1+ VA weight management visits in the 2 months after baseline, per administrative data and/or self-report of use of VA weight management programs via single item question.
COMPLETED
NA
470 participants
2-months post randomization
2026-05-22
Participant Flow
Potential participants were identified at the Palo and Houston VA medical centers based on administrative and clinical data. Recruitment occurred between 2022 and 2024.
Four participants were enrolled, but were not randomized because they did not complete the baseline assessment (n=3) or because they were found to be ineligible after enrollment (n=1).
Participant milestones
| Measure |
EMBER
Self-help tool to increase weight management engagement
|
Control
List of treatments
|
|---|---|---|
|
Overall Study
STARTED
|
233
|
233
|
|
Overall Study
COMPLETED
|
230
|
231
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
EMBER
Self-help tool to increase weight management engagement
|
Control
List of treatments
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
Baseline Characteristics
Four participants were enrolled, but were not randomized because they did not complete the baseline assessment (n=3) or because they were found to be ineligible after enrollment (n=1). Five participants completed baseline assessments, but withdrew permission to use self-report and/or administrative data (EMBER n=3, Control n = 2).
Baseline characteristics by cohort
| Measure |
Total
n=461 Participants
Total of all reporting groups
|
EMBER
n=230 Participants
Self-help tool to increase weight management engagement
|
Control
n=231 Participants
List of treatments
|
|---|---|---|---|
|
Age, Continuous
|
56.84 years
STANDARD_DEVIATION 14.68 • n=6 Participants • Four participants were enrolled, but were not randomized because they did not complete the baseline assessment (n=3) or because they were found to be ineligible after enrollment (n=1). Five participants completed baseline assessments, but withdrew permission to use self-report and/or administrative data (EMBER n=3, Control n = 2).
|
56.79 years
STANDARD_DEVIATION 14.08 • n=2 Participants • Four participants were enrolled, but were not randomized because they did not complete the baseline assessment (n=3) or because they were found to be ineligible after enrollment (n=1). Five participants completed baseline assessments, but withdrew permission to use self-report and/or administrative data (EMBER n=3, Control n = 2).
|
56.89 years
STANDARD_DEVIATION 15.28 • n=4 Participants • Four participants were enrolled, but were not randomized because they did not complete the baseline assessment (n=3) or because they were found to be ineligible after enrollment (n=1). Five participants completed baseline assessments, but withdrew permission to use self-report and/or administrative data (EMBER n=3, Control n = 2).
|
|
Sex: Female, Male
Female
|
158 Participants
n=6 Participants • Four participants were enrolled, but were not randomized because they did not complete the baseline assessment (n=3) or because they were found to be ineligible after enrollment (n=1). Five participants completed baseline assessments, but withdrew permission to use self-report and/or administrative data (EMBER n=3, Control n = 2).
|
79 Participants
n=2 Participants • Four participants were enrolled, but were not randomized because they did not complete the baseline assessment (n=3) or because they were found to be ineligible after enrollment (n=1). Five participants completed baseline assessments, but withdrew permission to use self-report and/or administrative data (EMBER n=3, Control n = 2).
|
79 Participants
n=4 Participants • Four participants were enrolled, but were not randomized because they did not complete the baseline assessment (n=3) or because they were found to be ineligible after enrollment (n=1). Five participants completed baseline assessments, but withdrew permission to use self-report and/or administrative data (EMBER n=3, Control n = 2).
|
|
Sex: Female, Male
Male
|
303 Participants
n=6 Participants • Four participants were enrolled, but were not randomized because they did not complete the baseline assessment (n=3) or because they were found to be ineligible after enrollment (n=1). Five participants completed baseline assessments, but withdrew permission to use self-report and/or administrative data (EMBER n=3, Control n = 2).
|
151 Participants
n=2 Participants • Four participants were enrolled, but were not randomized because they did not complete the baseline assessment (n=3) or because they were found to be ineligible after enrollment (n=1). Five participants completed baseline assessments, but withdrew permission to use self-report and/or administrative data (EMBER n=3, Control n = 2).
|
152 Participants
n=4 Participants • Four participants were enrolled, but were not randomized because they did not complete the baseline assessment (n=3) or because they were found to be ineligible after enrollment (n=1). Five participants completed baseline assessments, but withdrew permission to use self-report and/or administrative data (EMBER n=3, Control n = 2).
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
68 Participants
n=6 Participants • Four participants were enrolled, but were not randomized because they did not complete the baseline assessment (n=3) or because they were found to be ineligible after enrollment (n=1). Five participants completed baseline assessments, but withdrew permission to use self-report and/or administrative data (EMBER n=3, Control n = 2).
|
39 Participants
n=2 Participants • Four participants were enrolled, but were not randomized because they did not complete the baseline assessment (n=3) or because they were found to be ineligible after enrollment (n=1). Five participants completed baseline assessments, but withdrew permission to use self-report and/or administrative data (EMBER n=3, Control n = 2).
|
29 Participants
n=4 Participants • Four participants were enrolled, but were not randomized because they did not complete the baseline assessment (n=3) or because they were found to be ineligible after enrollment (n=1). Five participants completed baseline assessments, but withdrew permission to use self-report and/or administrative data (EMBER n=3, Control n = 2).
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
380 Participants
n=6 Participants • Four participants were enrolled, but were not randomized because they did not complete the baseline assessment (n=3) or because they were found to be ineligible after enrollment (n=1). Five participants completed baseline assessments, but withdrew permission to use self-report and/or administrative data (EMBER n=3, Control n = 2).
|
184 Participants
n=2 Participants • Four participants were enrolled, but were not randomized because they did not complete the baseline assessment (n=3) or because they were found to be ineligible after enrollment (n=1). Five participants completed baseline assessments, but withdrew permission to use self-report and/or administrative data (EMBER n=3, Control n = 2).
|
196 Participants
n=4 Participants • Four participants were enrolled, but were not randomized because they did not complete the baseline assessment (n=3) or because they were found to be ineligible after enrollment (n=1). Five participants completed baseline assessments, but withdrew permission to use self-report and/or administrative data (EMBER n=3, Control n = 2).
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=6 Participants • Four participants were enrolled, but were not randomized because they did not complete the baseline assessment (n=3) or because they were found to be ineligible after enrollment (n=1). Five participants completed baseline assessments, but withdrew permission to use self-report and/or administrative data (EMBER n=3, Control n = 2).
|
7 Participants
n=2 Participants • Four participants were enrolled, but were not randomized because they did not complete the baseline assessment (n=3) or because they were found to be ineligible after enrollment (n=1). Five participants completed baseline assessments, but withdrew permission to use self-report and/or administrative data (EMBER n=3, Control n = 2).
|
6 Participants
n=4 Participants • Four participants were enrolled, but were not randomized because they did not complete the baseline assessment (n=3) or because they were found to be ineligible after enrollment (n=1). Five participants completed baseline assessments, but withdrew permission to use self-report and/or administrative data (EMBER n=3, Control n = 2).
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
13 Participants
n=6 Participants • Four participants were enrolled, but were not randomized because they did not complete the baseline assessment (n=3) or because they were found to be ineligible after enrollment (n=1). Five participants completed baseline assessments, but withdrew permission to use self-report and/or administrative data (EMBER n=3, Control n = 2).
|
6 Participants
n=2 Participants • Four participants were enrolled, but were not randomized because they did not complete the baseline assessment (n=3) or because they were found to be ineligible after enrollment (n=1). Five participants completed baseline assessments, but withdrew permission to use self-report and/or administrative data (EMBER n=3, Control n = 2).
|
7 Participants
n=4 Participants • Four participants were enrolled, but were not randomized because they did not complete the baseline assessment (n=3) or because they were found to be ineligible after enrollment (n=1). Five participants completed baseline assessments, but withdrew permission to use self-report and/or administrative data (EMBER n=3, Control n = 2).
|
|
Race/Ethnicity, Customized
Asian
|
20 Participants
n=6 Participants • Four participants were enrolled, but were not randomized because they did not complete the baseline assessment (n=3) or because they were found to be ineligible after enrollment (n=1). Five participants completed baseline assessments, but withdrew permission to use self-report and/or administrative data (EMBER n=3, Control n = 2).
|
6 Participants
n=2 Participants • Four participants were enrolled, but were not randomized because they did not complete the baseline assessment (n=3) or because they were found to be ineligible after enrollment (n=1). Five participants completed baseline assessments, but withdrew permission to use self-report and/or administrative data (EMBER n=3, Control n = 2).
|
14 Participants
n=4 Participants • Four participants were enrolled, but were not randomized because they did not complete the baseline assessment (n=3) or because they were found to be ineligible after enrollment (n=1). Five participants completed baseline assessments, but withdrew permission to use self-report and/or administrative data (EMBER n=3, Control n = 2).
|
|
Race/Ethnicity, Customized
Black or African American
|
141 Participants
n=6 Participants • Four participants were enrolled, but were not randomized because they did not complete the baseline assessment (n=3) or because they were found to be ineligible after enrollment (n=1). Five participants completed baseline assessments, but withdrew permission to use self-report and/or administrative data (EMBER n=3, Control n = 2).
|
68 Participants
n=2 Participants • Four participants were enrolled, but were not randomized because they did not complete the baseline assessment (n=3) or because they were found to be ineligible after enrollment (n=1). Five participants completed baseline assessments, but withdrew permission to use self-report and/or administrative data (EMBER n=3, Control n = 2).
|
73 Participants
n=4 Participants • Four participants were enrolled, but were not randomized because they did not complete the baseline assessment (n=3) or because they were found to be ineligible after enrollment (n=1). Five participants completed baseline assessments, but withdrew permission to use self-report and/or administrative data (EMBER n=3, Control n = 2).
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
3 Participants
n=6 Participants • Four participants were enrolled, but were not randomized because they did not complete the baseline assessment (n=3) or because they were found to be ineligible after enrollment (n=1). Five participants completed baseline assessments, but withdrew permission to use self-report and/or administrative data (EMBER n=3, Control n = 2).
|
1 Participants
n=2 Participants • Four participants were enrolled, but were not randomized because they did not complete the baseline assessment (n=3) or because they were found to be ineligible after enrollment (n=1). Five participants completed baseline assessments, but withdrew permission to use self-report and/or administrative data (EMBER n=3, Control n = 2).
|
2 Participants
n=4 Participants • Four participants were enrolled, but were not randomized because they did not complete the baseline assessment (n=3) or because they were found to be ineligible after enrollment (n=1). Five participants completed baseline assessments, but withdrew permission to use self-report and/or administrative data (EMBER n=3, Control n = 2).
|
|
Race/Ethnicity, Customized
White
|
263 Participants
n=6 Participants • Four participants were enrolled, but were not randomized because they did not complete the baseline assessment (n=3) or because they were found to be ineligible after enrollment (n=1). Five participants completed baseline assessments, but withdrew permission to use self-report and/or administrative data (EMBER n=3, Control n = 2).
|
137 Participants
n=2 Participants • Four participants were enrolled, but were not randomized because they did not complete the baseline assessment (n=3) or because they were found to be ineligible after enrollment (n=1). Five participants completed baseline assessments, but withdrew permission to use self-report and/or administrative data (EMBER n=3, Control n = 2).
|
126 Participants
n=4 Participants • Four participants were enrolled, but were not randomized because they did not complete the baseline assessment (n=3) or because they were found to be ineligible after enrollment (n=1). Five participants completed baseline assessments, but withdrew permission to use self-report and/or administrative data (EMBER n=3, Control n = 2).
|
|
Race/Ethnicity, Customized
Another race
|
16 Participants
n=6 Participants • Four participants were enrolled, but were not randomized because they did not complete the baseline assessment (n=3) or because they were found to be ineligible after enrollment (n=1). Five participants completed baseline assessments, but withdrew permission to use self-report and/or administrative data (EMBER n=3, Control n = 2).
|
8 Participants
n=2 Participants • Four participants were enrolled, but were not randomized because they did not complete the baseline assessment (n=3) or because they were found to be ineligible after enrollment (n=1). Five participants completed baseline assessments, but withdrew permission to use self-report and/or administrative data (EMBER n=3, Control n = 2).
|
8 Participants
n=4 Participants • Four participants were enrolled, but were not randomized because they did not complete the baseline assessment (n=3) or because they were found to be ineligible after enrollment (n=1). Five participants completed baseline assessments, but withdrew permission to use self-report and/or administrative data (EMBER n=3, Control n = 2).
|
|
Race/Ethnicity, Customized
Declined to answer
|
5 Participants
n=6 Participants • Four participants were enrolled, but were not randomized because they did not complete the baseline assessment (n=3) or because they were found to be ineligible after enrollment (n=1). Five participants completed baseline assessments, but withdrew permission to use self-report and/or administrative data (EMBER n=3, Control n = 2).
|
4 Participants
n=2 Participants • Four participants were enrolled, but were not randomized because they did not complete the baseline assessment (n=3) or because they were found to be ineligible after enrollment (n=1). Five participants completed baseline assessments, but withdrew permission to use self-report and/or administrative data (EMBER n=3, Control n = 2).
|
1 Participants
n=4 Participants • Four participants were enrolled, but were not randomized because they did not complete the baseline assessment (n=3) or because they were found to be ineligible after enrollment (n=1). Five participants completed baseline assessments, but withdrew permission to use self-report and/or administrative data (EMBER n=3, Control n = 2).
|
PRIMARY outcome
Timeframe: 2-months post randomizationPopulation: Four participants were enrolled, but were not randomized because they did not complete the baseline assessment (n=3) or because they were found to be ineligible after enrollment (n=1). Five participants withdrew permission to use self-report and/or administrative data (EMBER n=3, Control n = 2).
Dichotomous variable representing whether participant has 1+ VA weight management visits in the 2 months after baseline, per administrative data and/or self-report of use of VA weight management programs via single item question.
Outcome measures
| Measure |
EMBER
n=230 Participants
Self-help tool to increase weight management engagement
|
Control
n=231 Participants
List of treatments
|
|---|---|---|
|
Weight Management Use
|
89 Participants
|
42 Participants
|
SECONDARY outcome
Timeframe: 6-months post randomizationPopulation: Four participants were enrolled, but were not randomized because they did not complete the baseline assessment (n=3) or because they were found to be ineligible after enrollment (n=1). Five participants withdrew permission to use self-report and/or administrative data (EMBER n=3, Control n = 2).
Dichotomous variable representing whether participant has 1+ VA weight management visits in the 6 months after baseline, per administrative data and/or self-report of use of VA weight management programs via single item question.
Outcome measures
| Measure |
EMBER
n=230 Participants
Self-help tool to increase weight management engagement
|
Control
n=231 Participants
List of treatments
|
|---|---|---|
|
Weight Management Use
|
100 Participants
|
56 Participants
|
SECONDARY outcome
Timeframe: 6-months post-randomizationPopulation: Four participants were enrolled, but were not randomized because they did not complete the baseline assessment (n=3) or because they were found to be ineligible after enrollment (n=1). Five participants withdrew permission to use self-report and/or administrative data (EMBER n=3, Control n = 2).
Number of weight management program visits per administrative data.
Outcome measures
| Measure |
EMBER
n=230 Participants
Self-help tool to increase weight management engagement
|
Control
n=231 Participants
List of treatments
|
|---|---|---|
|
Number of Weight Management Visits
|
0 Weight management visits
Interval 0.0 to 0.0
|
0 Weight management visits
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: 2-months post randomizationPopulation: Four participants were enrolled, but were not randomized because they did not complete the baseline assessment (n=3) or because they were found to be ineligible after enrollment (n=1). Five participants withdrew permission to use self-report and/or administrative data (EMBER n=3, Control n = 2). The remaining participants were lost to follow-up.
Count patients with new weight management behaviors since baseline visit via self-report to question based on NHANES item assessing whether participant tried to lose weight and how. Any change is considered meaningful.
Outcome measures
| Measure |
EMBER
n=178 Participants
Self-help tool to increase weight management engagement
|
Control
n=172 Participants
List of treatments
|
|---|---|---|
|
New Weight Management Behavior
|
109 Participants
|
85 Participants
|
SECONDARY outcome
Timeframe: 6-months post randomizationPopulation: Four participants were enrolled, but were not randomized because they did not complete the baseline assessment (n=3) or because they were found to be ineligible after enrollment (n=1). Five participants withdrew permission to use self-report and/or administrative data (EMBER n=3, Control n = 2). The remaining participants were lost to follow-up for self-report.
Count patients with new weight management behaviors since baseline visit via self-report to question based on NHANES item assessing whether participant tried to lose weight and how. Any change is considered meaningful.
Outcome measures
| Measure |
EMBER
n=161 Participants
Self-help tool to increase weight management engagement
|
Control
n=161 Participants
List of treatments
|
|---|---|---|
|
New Weight Management Behavior
|
106 Participants
|
94 Participants
|
SECONDARY outcome
Timeframe: 2--months post randomizationPopulation: Four participants were enrolled, but were not randomized because they did not complete the baseline assessment (n=3) or because they were found to be ineligible after enrollment (n=1). Five participants withdrew permission to use self-report and/or administrative data (EMBER n=3, Control n = 2). The remaining participants were lost to follow-up.
Self-report of quality of life as assessed with the VR12 physical and mental health composite scores (Boston University School of Public Health). Scores are standardized T-scores with mean = 50 and a standard deviation of 10. For individuals on the physical health score, a 6.5 unit change is considering clinically meaningful. For individuals on the mental health score, a 7.9 unit change is considering clinically meaningful. At the population level, a 1 unit change is considered clinically meaningful. Higher scores represent better quality of life.
Outcome measures
| Measure |
EMBER
n=178 Participants
Self-help tool to increase weight management engagement
|
Control
n=172 Participants
List of treatments
|
|---|---|---|
|
Quality of Life (Veterans RAND 12 Item Health Survey (VR-12))
Physical Health Quality of Life
|
36.1 Standardized T-scores
Standard Deviation 11.5
|
36.4 Standardized T-scores
Standard Deviation 10.9
|
|
Quality of Life (Veterans RAND 12 Item Health Survey (VR-12))
Mental Health Quality of Life
|
46.3 Standardized T-scores
Standard Deviation 13.5
|
46.2 Standardized T-scores
Standard Deviation 13.6
|
SECONDARY outcome
Timeframe: 6-months post randomizationPopulation: Four participants were enrolled, but were not randomized because they did not complete the baseline assessment (n=3) or because they were found to be ineligible after enrollment (n=1). Five participants withdrew permission to use self-report and/or administrative data (EMBER n=3, Control n = 2). The remaining participants were lost to follow-up.
Self-report of quality of life as assessed with the VR12 physical and mental health composite scores (Boston University School of Public Health). Scores are standardized T-scores with mean = 50 and a standard deviation of 10. For individuals on the physical health score, a 6.5 unit change is considering clinically meaningful. For individuals on the mental health score, a 7.9 unit change is considering clinically meaningful. At the population level, a 1 unit change is considered clinically meaningful. Higher scores represent better quality of life.
Outcome measures
| Measure |
EMBER
n=161 Participants
Self-help tool to increase weight management engagement
|
Control
n=161 Participants
List of treatments
|
|---|---|---|
|
Quality of Life (Veterans RAND 12 Item Health Survey (VR-12))
Mental Health Quality of Life
|
46.7 Standardized T-scores
Standard Deviation 13.3
|
45.9 Standardized T-scores
Standard Deviation 13.2
|
|
Quality of Life (Veterans RAND 12 Item Health Survey (VR-12))
Physical Health Quality of Life
|
37.4 Standardized T-scores
Standard Deviation 11.4
|
35.4 Standardized T-scores
Standard Deviation 11.3
|
SECONDARY outcome
Timeframe: 6-months post randomizationPopulation: Four participants were enrolled, but were not randomized because they did not complete the baseline assessment (n=3) or because they were found to be ineligible after enrollment (n=1). Five participants withdrew permission to use self-report and/or administrative data (EMBER n=3, Control n = 2). The remaining participants were lost to follow-up and/or did not have administrative weight data.
Number of participants with at least 5% weight loss at 6-months based on difference between self-reported weight at baseline and 6-months, supplemented with medical record data when possible.
Outcome measures
| Measure |
EMBER
n=170 Participants
Self-help tool to increase weight management engagement
|
Control
n=158 Participants
List of treatments
|
|---|---|---|
|
Weight Loss
|
41 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: 2-months post randomizationPopulation: Four participants were enrolled, but were not randomized because they did not complete the baseline assessment (n=3) or because they were found to be ineligible after enrollment (n=1). Five participants withdrew permission to use self-report and/or administrative data (EMBER n=3, Control n = 2). The remaining participants were lost to follow-up.
Measured with Stanford Leisure-Time Activity Categorical Item (L-Cat), which is a 6-level categorical measure with lower scores indicating less physical activity, which we scored from 1-6. An increase of one category is a clinically meaningful difference.
Outcome measures
| Measure |
EMBER
n=178 Participants
Self-help tool to increase weight management engagement
|
Control
n=172 Participants
List of treatments
|
|---|---|---|
|
Physical Activity (The Stanford Leisure-Time Activity Categorical Item (L-Cat))
|
3 Score on a scale
Interval 2.0 to 3.0
|
3 Score on a scale
Interval 2.0 to 4.0
|
SECONDARY outcome
Timeframe: 6-months post randomizationPopulation: Four participants were enrolled, but were not randomized because they did not complete the baseline assessment (n=3) or because they were found to be ineligible after enrollment (n=1). Five participants withdrew permission to use self-report and/or administrative data (EMBER n=3, Control n = 2). The remaining participants were lost to follow-up.
Measured with Stanford Leisure-Time Activity Categorical Item (L-Cat), which is a 6-level categorical measure with lower scores indicating less physical activity, which we scored from 1-6. An increase of one category is a clinically meaningful difference.
Outcome measures
| Measure |
EMBER
n=161 Participants
Self-help tool to increase weight management engagement
|
Control
n=161 Participants
List of treatments
|
|---|---|---|
|
Physical Activity (The Stanford Leisure-Time Activity Categorical Item (L-Cat))
|
3 Score on a scale
Interval 2.0 to 4.0
|
3 Score on a scale
Interval 2.0 to 4.0
|
Adverse Events
EMBER
Control
Prior to Randomization
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
EMBER
n=233 participants at risk
Self-help tool to increase weight management engagement
|
Control
n=233 participants at risk
List of treatments
|
Prior to Randomization
n=466 participants at risk
Event occurred after enrollment, but prior to randomization
|
|---|---|---|---|
|
Psychiatric disorders
Suicidal ideation with plan and/or intent
|
0.00%
0/233 • From enrollment through 6-month follow-up
|
0.43%
1/233 • Number of events 1 • From enrollment through 6-month follow-up
|
0.21%
1/466 • Number of events 1 • From enrollment through 6-month follow-up
|
Additional Information
Jessica Breland, Principal Investigator
VA Palo Alto Health Care System
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place