Trial Outcomes & Findings for MOVE!+UP: Testing a Tailored Weight Management Program for Veterans With PTSD (NCT NCT04563741)
NCT ID: NCT04563741
Last Updated: 2026-05-06
Results Overview
This study's primary aims is to test whether intervention participants have greater 6-month weight loss, relative to controls.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
174 participants
Primary outcome timeframe
baseline and 6 months post-baseline
Results posted on
2026-05-06
Participant Flow
From 10/1/2020-2/28/2024, we sent recruitment materials to cohorts of randomly selected veterans meeting several VHA electronic health record (EHR)-based criteria. Potentially eligible patients were also identified from self or clinician referral. We then used manual chart review to determine whether patients met additional criteria. We then further phone-screened participants for self-reported eligibility. To determine final eligibility, study staff conducted a video visit to assess weight/BMI.
We randomized 174 enrolled participants to MOVE! (control) or MOVE!+UP (intervention) in a 1:1 ratio within each recruitment cohort, using a permuted block design, with varying block sizes (2 or 4). People doing data collection and analysis remained masked until after 12-month data collection.
Participant milestones
| Measure |
Active Comparator: MOVE! (Control Condition)
MOVE! is the standard VA weight management intervention
|
Experimental: MOVE!+UP (Intervention)
MOVE!+UP is a novel behavioral weight management intervention developed for Veterans with PTSD
|
|---|---|---|
|
Overall Study
STARTED
|
89
|
85
|
|
Overall Study
COMPLETED
|
72
|
74
|
|
Overall Study
NOT COMPLETED
|
17
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
MOVE!+UP: Testing a Tailored Weight Management Program for Veterans With PTSD
Baseline characteristics by cohort
| Measure |
Active Comparator: MOVE!
n=89 Participants
VA's standard weight management program
|
Experimental Condition: MOVE!+UP
n=85 Participants
Behavioral weight management program for Veterans with PTSD
|
Total
n=174 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Male
|
57 Participants
n=54 Participants
|
56 Participants
n=60 Participants
|
113 Participants
n=114 Participants
|
|
Age, Continuous
|
55 years
STANDARD_DEVIATION 13 • n=54 Participants
|
54 years
STANDARD_DEVIATION 13 • n=60 Participants
|
55 years
STANDARD_DEVIATION 13 • n=114 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=54 Participants
|
29 Participants
n=60 Participants
|
61 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Black or African-American
|
12 Participants
n=54 Participants
|
19 Participants
n=60 Participants
|
31 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Multiple categories
|
12 Participants
n=54 Participants
|
12 Participants
n=60 Participants
|
24 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Other
|
7 Participants
n=54 Participants
|
5 Participants
n=60 Participants
|
12 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
White
|
58 Participants
n=54 Participants
|
49 Participants
n=60 Participants
|
107 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino--yes
|
9 Participants
n=54 Participants
|
8 Participants
n=60 Participants
|
17 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino--no
|
80 Participants
n=54 Participants
|
77 Participants
n=60 Participants
|
157 Participants
n=114 Participants
|
|
Household annual family income
Less than or equal to $40,000
|
18 Participants
n=54 Participants
|
18 Participants
n=60 Participants
|
36 Participants
n=114 Participants
|
|
Household annual family income
$40,001-60,000
|
20 Participants
n=54 Participants
|
14 Participants
n=60 Participants
|
34 Participants
n=114 Participants
|
|
Household annual family income
$60,001-$80,000
|
12 Participants
n=54 Participants
|
14 Participants
n=60 Participants
|
26 Participants
n=114 Participants
|
|
Household annual family income
$80,001-$100,000
|
16 Participants
n=54 Participants
|
14 Participants
n=60 Participants
|
30 Participants
n=114 Participants
|
|
Household annual family income
> $100,000
|
20 Participants
n=54 Participants
|
22 Participants
n=60 Participants
|
42 Participants
n=114 Participants
|
|
Household annual family income
Missing
|
3 Participants
n=54 Participants
|
3 Participants
n=60 Participants
|
6 Participants
n=114 Participants
|
|
Body Mass Index
|
34.7 kg/m^2
STANDARD_DEVIATION 5.7 • n=54 Participants
|
33.9 kg/m^2
STANDARD_DEVIATION 5.2 • n=60 Participants
|
34.3 kg/m^2
STANDARD_DEVIATION 5.5 • n=114 Participants
|
PRIMARY outcome
Timeframe: baseline and 6 months post-baselineThis study's primary aims is to test whether intervention participants have greater 6-month weight loss, relative to controls.
Outcome measures
| Measure |
Active Comparator: MOVE!
n=72 Participants
VA's standard weight management program
|
Experimental Condition: MOVE!+UP
n=74 Participants
Behavioral weight management program for Veterans with PTSD
|
|---|---|---|
|
Weight (Pounds) Change From Baseline to 6 Months Post-baseline
|
-7.8 pounds
Standard Deviation 13.8
|
-8.9 pounds
Standard Deviation 13.7
|
SECONDARY outcome
Timeframe: baseline and 12 months post-baselineTest whether intervention participants have greater long-term (12-month) weight loss, relative to controls.
Outcome measures
| Measure |
Active Comparator: MOVE!
n=68 Participants
VA's standard weight management program
|
Experimental Condition: MOVE!+UP
n=75 Participants
Behavioral weight management program for Veterans with PTSD
|
|---|---|---|
|
Weight (Pounds) Change From Baseline to 12 Months Post-baseline
|
-8.0 pounds
Standard Deviation 16.4
|
-8.8 pounds
Standard Deviation 17.7
|
SECONDARY outcome
Timeframe: baseline and 6 months post-baselineAssess whether compared to control, intervention participants have greater improvements on 6-month PTSD symptom severity. Total scores range 0 - 80, where higher scores are indicative of greater severity.
Outcome measures
| Measure |
Active Comparator: MOVE!
n=72 Participants
VA's standard weight management program
|
Experimental Condition: MOVE!+UP
n=74 Participants
Behavioral weight management program for Veterans with PTSD
|
|---|---|---|
|
PTSD Symptom Severity on the PTSD Checklist for DSM-5 Change From Baseline to 6 Months Post-baseline
|
-7.6 score on a scale
Standard Deviation 9.9
|
-7.9 score on a scale
Standard Deviation 12.7
|
SECONDARY outcome
Timeframe: baseline and 12 months post-baselineAssess whether compared to control, intervention participants have greater improvements on 12-month PTSD symptom severity. Total scores range 0 - 80, where higher scores are indicative of greater severity.
Outcome measures
| Measure |
Active Comparator: MOVE!
n=67 Participants
VA's standard weight management program
|
Experimental Condition: MOVE!+UP
n=74 Participants
Behavioral weight management program for Veterans with PTSD
|
|---|---|---|
|
PTSD Symptom Severity on the PTSD Checklist for DSM-5 Change From Baseline to 12 Months Post-baseline
|
-9.6 score on a scale
Standard Deviation 12.9
|
-7.4 score on a scale
Standard Deviation 14.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline and 6 months post-baselineAssess whether compared to control, intervention participants have greater improvements on 6-month insomnia severity. Total scores range 0 - 28, with higher scores indicating more acute symptoms of insomnia.
Outcome measures
| Measure |
Active Comparator: MOVE!
n=66 Participants
VA's standard weight management program
|
Experimental Condition: MOVE!+UP
n=70 Participants
Behavioral weight management program for Veterans with PTSD
|
|---|---|---|
|
Insomnia Measured With the Insomnia Severity Index Change From Baseline to 6 Months Post-baseline
|
-0.9 score on a scale
Standard Deviation 5.0
|
-1.2 score on a scale
Standard Deviation 6.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline and 6 months post-baselineAssess whether compared to control, intervention participants have greater improvements on 6-month accelerometry-based light, moderate, and vigorous physical activity. This variable combines all forms of physical activity into a single measure.
Outcome measures
| Measure |
Active Comparator: MOVE!
n=54 Participants
VA's standard weight management program
|
Experimental Condition: MOVE!+UP
n=59 Participants
Behavioral weight management program for Veterans with PTSD
|
|---|---|---|
|
Average Daily Light, Moderate, and Vigorous Physical Activity Measured With Accelerometers (Change From Baseline to 6 Months Post-baseline)
|
-7.8 minutes
Standard Deviation 76.0
|
1.8 minutes
Standard Deviation 82.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline and 6 months post-baselineAssess whether compared to control, intervention participants have greater improvements on 6-month accelerometry-based moderate and vigorous physical activity. This measure combines only moderate and vigorous activity because this is the higher activity threshold to achieve and more closely aligns with the type of activity recommended in standard activity recommendations.
Outcome measures
| Measure |
Active Comparator: MOVE!
n=54 Participants
VA's standard weight management program
|
Experimental Condition: MOVE!+UP
n=59 Participants
Behavioral weight management program for Veterans with PTSD
|
|---|---|---|
|
Average Daily Moderate and Vigorous Physical Activity Measured With Accelerometers (Change From Baseline to 6-months Post-baseline)
|
-2.3 minutes
Standard Deviation 40.5
|
0.0 minutes
Standard Deviation 47.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline and 6 months post-baselineAssess whether compared to control, intervention participants have greater improvements on 6-month depression symptoms. Total scores range 0 - 24 where higher scores indicate greater depression severity.
Outcome measures
| Measure |
Active Comparator: MOVE!
n=68 Participants
VA's standard weight management program
|
Experimental Condition: MOVE!+UP
n=71 Participants
Behavioral weight management program for Veterans with PTSD
|
|---|---|---|
|
Depression Severity Measured With the Patient Health Questionnaire, 8-item Version (Change From Baseline to 6 Months Post-baseline)
|
-1.9 score on a scale
Standard Deviation 4.6
|
-1.4 score on a scale
Standard Deviation 4.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline and 6 months post-baselineAssess whether compared to control, intervention participants have greater improvements on 6-month internalized weight bias. The measure was changed only slightly to add one item reflecting positive body image: "I love my shape and size." Scores for items were summed and then averaged, with those for positive body image reverse-scored. Scores ranged from 1-7, with higher scores representing worse weight bias internalization.
Outcome measures
| Measure |
Active Comparator: MOVE!
n=68 Participants
VA's standard weight management program
|
Experimental Condition: MOVE!+UP
n=72 Participants
Behavioral weight management program for Veterans with PTSD
|
|---|---|---|
|
Internalized Weight Bias Measured With "Modified Weight Bias Internalization Scale" (Change From Baseline to 6 Months Post-baseline)
|
-0.2 score
Standard Deviation 0.9
|
-0.3 score
Standard Deviation 1.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline and 6 months post-baselineAssess whether compared to control, intervention participants have greater improvements on 6-month eating habits. Scores for items were summed and then averaged, with a summary score range from 0-4, with higher scores indicating worse eating habits.
Outcome measures
| Measure |
Active Comparator: MOVE!
n=68 Participants
VA's standard weight management program
|
Experimental Condition: MOVE!+UP
n=72 Participants
Behavioral weight management program for Veterans with PTSD
|
|---|---|---|
|
Eating Habits Measured With "PACE" Eating Habits Measure (Change From Baseline to 6 Months Post-baseline)
|
-0.3 scores on a scale
Standard Deviation 0.5
|
-0.5 scores on a scale
Standard Deviation 0.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline and 6 months post-baselineAssess whether compared to control, intervention participants have greater improvements on 6-month social support for physical activity. Scores for items were summed and then averaged. Scores ranged from 0-4, with higher scores indicating better support.
Outcome measures
| Measure |
Active Comparator: MOVE!
n=68 Participants
VA's standard weight management program
|
Experimental Condition: MOVE!+UP
n=71 Participants
Behavioral weight management program for Veterans with PTSD
|
|---|---|---|
|
Social Support for Physical Activity (Change From Baseline to 6 Months Post-baseline)
|
0.1 scores on a scale
Standard Deviation 0.6
|
-0.1 scores on a scale
Standard Deviation 0.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline and 6 months post-baselineAssess whether compared to control, intervention participants have greater improvements on 6-month social support for healthy eating. Scores for items were summed and then averaged. Scores ranged from 0-4, with higher scores indicating better support.
Outcome measures
| Measure |
Active Comparator: MOVE!
n=68 Participants
VA's standard weight management program
|
Experimental Condition: MOVE!+UP
n=72 Participants
Behavioral weight management program for Veterans with PTSD
|
|---|---|---|
|
Social Support for Healthy Eating (Change From Baseline to 6 Months Post-baseline)
|
0.0 scores on a scale
Standard Deviation 0.7
|
0.1 scores on a scale
Standard Deviation 0.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline and 6 months post-baselineAssess whether compared to control, intervention participants have greater improvements on 6-month discouragement for healthy eating. Scores for items were summed and then averaged. Scores ranged from 0-4, with higher scores indicating greater discouragement.
Outcome measures
| Measure |
Active Comparator: MOVE!
n=68 Participants
VA's standard weight management program
|
Experimental Condition: MOVE!+UP
n=71 Participants
Behavioral weight management program for Veterans with PTSD
|
|---|---|---|
|
Discouragement for Healthy Eating (Change From Baseline to 6 Months Post-baseline)
|
0.0 scores on a scale
Standard Deviation 0.6
|
-0.1 scores on a scale
Standard Deviation 0.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline and 6 months post-baselineAssess whether compared to control, intervention participants have greater improvements on 6-month discouragement for physical activity. Scores for items were summed and then averaged. Scores ranged from 0-4, with higher scores indicating greater discouragement.
Outcome measures
| Measure |
Active Comparator: MOVE!
n=67 Participants
VA's standard weight management program
|
Experimental Condition: MOVE!+UP
n=72 Participants
Behavioral weight management program for Veterans with PTSD
|
|---|---|---|
|
Discouragement for Physical Activity (Change From Baseline to 6 Months Post-baseline)
|
-0.0 scores on a scale
Standard Deviation 0.5
|
0.0 scores on a scale
Standard Deviation 0.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline and 6 months post-baselineAssess whether compared to control, intervention participants have greater improvements on 6-month night eating symptoms. Scores for items were summed. The overall scale score ranged from 0-24, with higher scores indicating greater night eating.
Outcome measures
| Measure |
Active Comparator: MOVE!
n=68 Participants
VA's standard weight management program
|
Experimental Condition: MOVE!+UP
n=70 Participants
Behavioral weight management program for Veterans with PTSD
|
|---|---|---|
|
Night Eating Measured With the Night Eating Questionnaire (Change From Baseline to 6 Months Post-baseline)
|
-1.7 score
Standard Deviation 3.8
|
-1.6 score
Standard Deviation 3.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline and 6 months post-baselineAssess whether compared to control, intervention participants have greater improvements on 6-month emotional eating. Scores for items were summed and then averaged. Scores ranged from 0-4, with higher scores indicating greater emotional eating.
Outcome measures
| Measure |
Active Comparator: MOVE!
n=67 Participants
VA's standard weight management program
|
Experimental Condition: MOVE!+UP
n=70 Participants
Behavioral weight management program for Veterans with PTSD
|
|---|---|---|
|
Emotional Eating Measured With the Emotional Overeating Questionnaire (Change From Baseline to 6 Months Post-baseline)
|
-0.4 scores on a scale
Standard Deviation 0.9
|
-0.5 scores on a scale
Standard Deviation 1.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline and 6 months post-baselineAssess whether compared to control, intervention participants have greater improvements on 6-month diet quality. Scores for items were summed. The overall score for the scale ranged from 0-16, with higher scores indicating worse diet quality.
Outcome measures
| Measure |
Active Comparator: MOVE!
n=68 Participants
VA's standard weight management program
|
Experimental Condition: MOVE!+UP
n=71 Participants
Behavioral weight management program for Veterans with PTSD
|
|---|---|---|
|
Diet Quality Measured With "Starting the Conversation" (Change From Baseline to 6 Months Post-baseline)
|
-1.5 scores on a scale
Standard Deviation 2.7
|
-1.5 scores on a scale
Standard Deviation 2.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months post-baselineAssess whether compared to control, intervention participants have lower prevalence of engaging in binge eating at 6 months post-baseline. Those reporting current binge eating behavior (with or without engaging in purging) were designated as yes, binge eating, and the outcome prevalence is presented for those who do engage in binge eating. Those who did not endorse binge eating behavior were designated as no.
Outcome measures
| Measure |
Active Comparator: MOVE!
n=68 Participants
VA's standard weight management program
|
Experimental Condition: MOVE!+UP
n=72 Participants
Behavioral weight management program for Veterans with PTSD
|
|---|---|---|
|
Binge Eating (Yes vs. no at 6 Months Post-baseline) Measured Using an Adapted Patient Health Questionnaire for DSM 5 Criteria
|
7 Participants
0.4
|
7 Participants
0.4
|
Adverse Events
Active Comparator: MOVE!
Serious events: 5 serious events
Other events: 60 other events
Deaths: 2 deaths
Experimental Condition: MOVE!+UP
Serious events: 5 serious events
Other events: 60 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Active Comparator: MOVE!
n=89 participants at risk
VA's standard weight management program
|
Experimental Condition: MOVE!+UP
n=85 participants at risk
Behavioral weight management program for Veterans with PTSD
|
|---|---|---|
|
Cardiac disorders
Blood Clot
|
1.1%
1/89 • Number of events 1 • Enrollment through 12-month follow-up
|
0.00%
0/85 • Enrollment through 12-month follow-up
|
|
Cardiac disorders
Stroke (death)
|
1.1%
1/89 • Number of events 1 • Enrollment through 12-month follow-up
|
0.00%
0/85 • Enrollment through 12-month follow-up
|
|
Cardiac disorders
Syncope
|
0.00%
0/89 • Enrollment through 12-month follow-up
|
1.2%
1/85 • Number of events 1 • Enrollment through 12-month follow-up
|
|
Gastrointestinal disorders
Pacreatitis
|
0.00%
0/89 • Enrollment through 12-month follow-up
|
2.4%
2/85 • Number of events 2 • Enrollment through 12-month follow-up
|
|
Infections and infestations
Sepsis
|
1.1%
1/89 • Number of events 1 • Enrollment through 12-month follow-up
|
0.00%
0/85 • Enrollment through 12-month follow-up
|
|
Metabolism and nutrition disorders
Diabetes
|
0.00%
0/89 • Enrollment through 12-month follow-up
|
1.2%
1/85 • Number of events 1 • Enrollment through 12-month follow-up
|
|
Blood and lymphatic system disorders
Lymphoma
|
0.00%
0/89 • Enrollment through 12-month follow-up
|
1.2%
1/85 • Number of events 1 • Enrollment through 12-month follow-up
|
|
Nervous system disorders
Seizures
|
1.1%
1/89 • Number of events 1 • Enrollment through 12-month follow-up
|
0.00%
0/85 • Enrollment through 12-month follow-up
|
|
Metabolism and nutrition disorders
Diabetes (death)
|
1.1%
1/89 • Number of events 1 • Enrollment through 12-month follow-up
|
0.00%
0/85 • Enrollment through 12-month follow-up
|
Other adverse events
| Measure |
Active Comparator: MOVE!
n=89 participants at risk
VA's standard weight management program
|
Experimental Condition: MOVE!+UP
n=85 participants at risk
Behavioral weight management program for Veterans with PTSD
|
|---|---|---|
|
Gastrointestinal disorders
Stomach Pain/Distress
|
3.4%
3/89 • Number of events 3 • Enrollment through 12-month follow-up
|
5.9%
5/85 • Number of events 5 • Enrollment through 12-month follow-up
|
|
Gastrointestinal disorders
Surgery
|
0.00%
0/89 • Enrollment through 12-month follow-up
|
1.2%
1/85 • Number of events 1 • Enrollment through 12-month follow-up
|
|
Gastrointestinal disorders
Esophagus
|
2.2%
2/89 • Number of events 2 • Enrollment through 12-month follow-up
|
0.00%
0/85 • Enrollment through 12-month follow-up
|
|
Gastrointestinal disorders
Pacreatitis
|
1.1%
1/89 • Number of events 2 • Enrollment through 12-month follow-up
|
0.00%
0/85 • Enrollment through 12-month follow-up
|
|
Gastrointestinal disorders
Liver/Cirrhosis
|
0.00%
0/89 • Enrollment through 12-month follow-up
|
1.2%
1/85 • Number of events 1 • Enrollment through 12-month follow-up
|
|
Gastrointestinal disorders
Crohn's Disease
|
0.00%
0/89 • Enrollment through 12-month follow-up
|
1.2%
1/85 • Number of events 1 • Enrollment through 12-month follow-up
|
|
Blood and lymphatic system disorders
Blood Clot
|
1.1%
1/89 • Number of events 1 • Enrollment through 12-month follow-up
|
1.2%
1/85 • Number of events 1 • Enrollment through 12-month follow-up
|
|
Metabolism and nutrition disorders
Metabolic Syndrome
|
1.1%
1/89 • Number of events 1 • Enrollment through 12-month follow-up
|
0.00%
0/85 • Enrollment through 12-month follow-up
|
|
Metabolism and nutrition disorders
Diabetes
|
2.2%
2/89 • Number of events 2 • Enrollment through 12-month follow-up
|
2.4%
2/85 • Number of events 2 • Enrollment through 12-month follow-up
|
|
Nervous system disorders
Hematoma
|
1.1%
1/89 • Number of events 1 • Enrollment through 12-month follow-up
|
0.00%
0/85 • Enrollment through 12-month follow-up
|
|
Nervous system disorders
Pain/Migraines/Dizziness
|
4.5%
4/89 • Number of events 4 • Enrollment through 12-month follow-up
|
7.1%
6/85 • Number of events 7 • Enrollment through 12-month follow-up
|
|
Nervous system disorders
Tumor
|
0.00%
0/89 • Enrollment through 12-month follow-up
|
1.2%
1/85 • Number of events 1 • Enrollment through 12-month follow-up
|
|
Nervous system disorders
Parkinsons
|
0.00%
0/89 • Enrollment through 12-month follow-up
|
1.2%
1/85 • Number of events 1 • Enrollment through 12-month follow-up
|
|
Nervous system disorders
Circulatory
|
1.1%
1/89 • Number of events 1 • Enrollment through 12-month follow-up
|
1.2%
1/85 • Number of events 1 • Enrollment through 12-month follow-up
|
|
Nervous system disorders
Vision/Memory Loss
|
1.1%
1/89 • Number of events 2 • Enrollment through 12-month follow-up
|
0.00%
0/85 • Enrollment through 12-month follow-up
|
|
Nervous system disorders
Head Injury/Concussion
|
1.1%
1/89 • Number of events 1 • Enrollment through 12-month follow-up
|
1.2%
1/85 • Number of events 1 • Enrollment through 12-month follow-up
|
|
Nervous system disorders
Stroke/Related Conditions
|
2.2%
2/89 • Number of events 2 • Enrollment through 12-month follow-up
|
0.00%
0/85 • Enrollment through 12-month follow-up
|
|
Reproductive system and breast disorders
Pain/Bleeding
|
2.2%
2/89 • Number of events 2 • Enrollment through 12-month follow-up
|
0.00%
0/85 • Enrollment through 12-month follow-up
|
|
Reproductive system and breast disorders
Surgery
|
0.00%
0/89 • Enrollment through 12-month follow-up
|
1.2%
1/85 • Number of events 1 • Enrollment through 12-month follow-up
|
|
Reproductive system and breast disorders
Birth Control
|
0.00%
0/89 • Enrollment through 12-month follow-up
|
1.2%
1/85 • Number of events 1 • Enrollment through 12-month follow-up
|
|
Reproductive system and breast disorders
Endomitriosis
|
0.00%
0/89 • Enrollment through 12-month follow-up
|
1.2%
1/85 • Number of events 1 • Enrollment through 12-month follow-up
|
|
Eye disorders
Surgery
|
1.1%
1/89 • Number of events 1 • Enrollment through 12-month follow-up
|
0.00%
0/85 • Enrollment through 12-month follow-up
|
|
Eye disorders
Infection/Disease
|
0.00%
0/89 • Enrollment through 12-month follow-up
|
3.5%
3/85 • Number of events 3 • Enrollment through 12-month follow-up
|
|
Eye disorders
Injury
|
1.1%
1/89 • Number of events 1 • Enrollment through 12-month follow-up
|
0.00%
0/85 • Enrollment through 12-month follow-up
|
|
Ear and labyrinth disorders
Infection
|
1.1%
1/89 • Number of events 1 • Enrollment through 12-month follow-up
|
2.4%
2/85 • Number of events 2 • Enrollment through 12-month follow-up
|
|
Ear and labyrinth disorders
Tinnitus/Hearing Loss
|
2.2%
2/89 • Number of events 2 • Enrollment through 12-month follow-up
|
0.00%
0/85 • Enrollment through 12-month follow-up
|
|
Ear and labyrinth disorders
Surgery
|
0.00%
0/89 • Enrollment through 12-month follow-up
|
1.2%
1/85 • Number of events 1 • Enrollment through 12-month follow-up
|
|
Psychiatric disorders
Suicidal Ideation
|
1.1%
1/89 • Number of events 1 • Enrollment through 12-month follow-up
|
5.9%
5/85 • Number of events 5 • Enrollment through 12-month follow-up
|
|
Psychiatric disorders
Withdrawal Symptoms
|
0.00%
0/89 • Enrollment through 12-month follow-up
|
1.2%
1/85 • Number of events 1 • Enrollment through 12-month follow-up
|
|
Psychiatric disorders
Eating Disorder
|
1.1%
1/89 • Number of events 1 • Enrollment through 12-month follow-up
|
2.4%
2/85 • Number of events 2 • Enrollment through 12-month follow-up
|
|
Psychiatric disorders
Mood Affect
|
1.1%
1/89 • Number of events 1 • Enrollment through 12-month follow-up
|
1.2%
1/85 • Number of events 1 • Enrollment through 12-month follow-up
|
|
Psychiatric disorders
Increased PTSD Symptoms
|
6.7%
6/89 • Number of events 6 • Enrollment through 12-month follow-up
|
8.2%
7/85 • Number of events 8 • Enrollment through 12-month follow-up
|
|
Psychiatric disorders
Increased Mental Health Symptoms
|
9.0%
8/89 • Number of events 8 • Enrollment through 12-month follow-up
|
10.6%
9/85 • Number of events 9 • Enrollment through 12-month follow-up
|
|
Psychiatric disorders
New Mental Health Diagnosis
|
0.00%
0/89 • Enrollment through 12-month follow-up
|
3.5%
3/85 • Number of events 3 • Enrollment through 12-month follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
2.2%
2/89 • Number of events 2 • Enrollment through 12-month follow-up
|
5.9%
5/85 • Number of events 5 • Enrollment through 12-month follow-up
|
|
Respiratory, thoracic and mediastinal disorders
COVID-19
|
5.6%
5/89 • Number of events 5 • Enrollment through 12-month follow-up
|
7.1%
6/85 • Number of events 7 • Enrollment through 12-month follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
2.2%
2/89 • Number of events 2 • Enrollment through 12-month follow-up
|
0.00%
0/85 • Enrollment through 12-month follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Infection
|
7.9%
7/89 • Number of events 7 • Enrollment through 12-month follow-up
|
7.1%
6/85 • Number of events 7 • Enrollment through 12-month follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Nodules
|
1.1%
1/89 • Number of events 1 • Enrollment through 12-month follow-up
|
2.4%
2/85 • Number of events 2 • Enrollment through 12-month follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Cancer
|
1.1%
1/89 • Number of events 1 • Enrollment through 12-month follow-up
|
0.00%
0/85 • Enrollment through 12-month follow-up
|
|
Renal and urinary disorders
Kidney Stones
|
1.1%
1/89 • Number of events 1 • Enrollment through 12-month follow-up
|
3.5%
3/85 • Number of events 3 • Enrollment through 12-month follow-up
|
|
Renal and urinary disorders
Blood Clot
|
1.1%
1/89 • Number of events 1 • Enrollment through 12-month follow-up
|
0.00%
0/85 • Enrollment through 12-month follow-up
|
|
Renal and urinary disorders
Infection
|
3.4%
3/89 • Number of events 3 • Enrollment through 12-month follow-up
|
0.00%
0/85 • Enrollment through 12-month follow-up
|
|
Renal and urinary disorders
Incontinence
|
1.1%
1/89 • Number of events 1 • Enrollment through 12-month follow-up
|
0.00%
0/85 • Enrollment through 12-month follow-up
|
|
Renal and urinary disorders
Cancer
|
0.00%
0/89 • Enrollment through 12-month follow-up
|
2.4%
2/85 • Number of events 2 • Enrollment through 12-month follow-up
|
|
Renal and urinary disorders
Prostate
|
1.1%
1/89 • Number of events 1 • Enrollment through 12-month follow-up
|
0.00%
0/85 • Enrollment through 12-month follow-up
|
|
Musculoskeletal and connective tissue disorders
Fall/injury
|
14.6%
13/89 • Number of events 14 • Enrollment through 12-month follow-up
|
15.3%
13/85 • Number of events 13 • Enrollment through 12-month follow-up
|
|
Cardiac disorders
Blood Pressure
|
2.2%
2/89 • Number of events 2 • Enrollment through 12-month follow-up
|
7.1%
6/85 • Number of events 8 • Enrollment through 12-month follow-up
|
|
Cardiac disorders
High Cholesterol
|
0.00%
0/89 • Enrollment through 12-month follow-up
|
2.4%
2/85 • Number of events 2 • Enrollment through 12-month follow-up
|
|
Cardiac disorders
Chest Pain/Pacemaker
|
3.4%
3/89 • Number of events 3 • Enrollment through 12-month follow-up
|
1.2%
1/85 • Number of events 1 • Enrollment through 12-month follow-up
|
|
Cardiac disorders
Blood Clot
|
1.1%
1/89 • Number of events 1 • Enrollment through 12-month follow-up
|
0.00%
0/85 • Enrollment through 12-month follow-up
|
|
Cardiac disorders
Congestive Heart Failure
|
0.00%
0/89 • Enrollment through 12-month follow-up
|
1.2%
1/85 • Number of events 2 • Enrollment through 12-month follow-up
|
|
Skin and subcutaneous tissue disorders
Surgery
|
0.00%
0/89 • Enrollment through 12-month follow-up
|
1.2%
1/85 • Number of events 1 • Enrollment through 12-month follow-up
|
|
Skin and subcutaneous tissue disorders
Melanoma/Carcinoma
|
2.2%
2/89 • Number of events 3 • Enrollment through 12-month follow-up
|
0.00%
0/85 • Enrollment through 12-month follow-up
|
|
Skin and subcutaneous tissue disorders
Injury
|
1.1%
1/89 • Number of events 1 • Enrollment through 12-month follow-up
|
0.00%
0/85 • Enrollment through 12-month follow-up
|
|
Skin and subcutaneous tissue disorders
Infection
|
2.2%
2/89 • Number of events 2 • Enrollment through 12-month follow-up
|
0.00%
0/85 • Enrollment through 12-month follow-up
|
|
Gastrointestinal disorders
Colon
|
1.1%
1/89 • Number of events 2 • Enrollment through 12-month follow-up
|
0.00%
0/85 • Enrollment through 12-month follow-up
|
|
Musculoskeletal and connective tissue disorders
Joint/Limb/Scar Pain
|
29.2%
26/89 • Number of events 29 • Enrollment through 12-month follow-up
|
18.8%
16/85 • Number of events 22 • Enrollment through 12-month follow-up
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid Arthritis
|
1.1%
1/89 • Number of events 1 • Enrollment through 12-month follow-up
|
0.00%
0/85 • Enrollment through 12-month follow-up
|
|
Musculoskeletal and connective tissue disorders
Neuropathy
|
0.00%
0/89 • Enrollment through 12-month follow-up
|
5.9%
5/85 • Number of events 5 • Enrollment through 12-month follow-up
|
Additional Information
Katherine Hoerster, PhD, MPH (Principal Investigator)
VA Puget Sound Health Care System, Seattle Division
Phone: 206-277-4203
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place