Trial Outcomes & Findings for Improving Obesity Self-Care Among Mentally Ill Veterans (NCT NCT02642536)
NCT ID: NCT02642536
Last Updated: 2018-02-22
Results Overview
Number of MOVE! sessions attended minimum-maximum total score range (2-12) Higher value represents more sessions attended The score was obtained from a single item
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
44 participants
Primary outcome timeframe
16 weeks
Results posted on
2018-02-22
Participant Flow
Participant milestones
| Measure |
MH MOVE
provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 10 phone based clinician led CBT sessions
MH MOVE: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 10 phone based clinician led CBT sessions
|
Enhanced Usual Care
provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided.
Enhanced Usual Care: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided.
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
23
|
|
Overall Study
COMPLETED
|
19
|
18
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Improving Obesity Self-Care Among Mentally Ill Veterans
Baseline characteristics by cohort
| Measure |
MH MOVE
n=21 Participants
provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions
MH MOVE: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions
|
Enhanced Usual Care
n=23 Participants
provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided.
Enhanced Usual Care: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided.
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.65 years
STANDARD_DEVIATION 8.9 • n=99 Participants
|
58.3 years
STANDARD_DEVIATION 9.5 • n=107 Participants
|
58.65 years
STANDARD_DEVIATION 9.11 • n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 16 weeksNumber of MOVE! sessions attended minimum-maximum total score range (2-12) Higher value represents more sessions attended The score was obtained from a single item
Outcome measures
| Measure |
MH MOVE
n=19 Participants
provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions
MH MOVE: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions
|
Enhanced Usual Care
n=18 Participants
provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided.
Enhanced Usual Care: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided.
|
|---|---|---|
|
MOVE! Attendance
|
5.9 number of sessions
Standard Deviation 1.8
|
5.8 number of sessions
Standard Deviation 1.8
|
PRIMARY outcome
Timeframe: 16 weekschanges in vigor and time spent on physical activity practice will be measured by the MOVE! 11 assessment at post treatment (16 weeks) minimum-maximum total score range (0-48) Higher value represents more days spent performing vigorous activity
Outcome measures
| Measure |
MH MOVE
n=19 Participants
provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions
MH MOVE: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions
|
Enhanced Usual Care
n=18 Participants
provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided.
Enhanced Usual Care: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided.
|
|---|---|---|
|
Number of Days Engaged in Vigorous Activity
|
21.5 days spent performing vigorous activity
Standard Deviation 11.5
|
26.9 days spent performing vigorous activity
Standard Deviation 18
|
PRIMARY outcome
Timeframe: baselineInitial assessment of vigor and time spent on physical activity minimum-maximum total score range (0-32) Higher value represents more days spent performing vigorous physical activity The score was obtained from a single item
Outcome measures
| Measure |
MH MOVE
n=19 Participants
provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions
MH MOVE: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions
|
Enhanced Usual Care
n=18 Participants
provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided.
Enhanced Usual Care: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided.
|
|---|---|---|
|
Number of Days Engaged in Vigorous Activity
|
27.7 days spent performing vigorous activity
Standard Deviation 22.1
|
28.1 days spent performing vigorous activity
Standard Deviation 15.3
|
PRIMARY outcome
Timeframe: baselineSelf-efficacy for practicing healthy dietary habits during difficult times will be assessed at baseline and post treatment (16 weeks) minimum-maximum total score range (20-100) Higher value represents greater sense of self-efficacy for healthy eating during difficult times The score was obtained from 3 subscales
Outcome measures
| Measure |
MH MOVE
n=19 Participants
provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions
MH MOVE: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions
|
Enhanced Usual Care
n=18 Participants
provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided.
Enhanced Usual Care: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided.
|
|---|---|---|
|
Self Efficacy for Practicing Good Dietary Habits
|
32.3 units on a scale
Standard Deviation 19.2
|
29.8 units on a scale
Standard Deviation 6.0
|
PRIMARY outcome
Timeframe: 16 weeksSelf-efficacy for practicing healthy dietary habits during difficult times will be assessed at baseline and post treatment (16 weeks) minimum-maximum total score range (20-100) Higher value represents greater sense of self-efficacy for healthy eating during difficult times The score was obtained from 3 subscales
Outcome measures
| Measure |
MH MOVE
n=19 Participants
provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions
MH MOVE: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions
|
Enhanced Usual Care
n=18 Participants
provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided.
Enhanced Usual Care: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided.
|
|---|---|---|
|
Self Efficacy for Practicing Good Dietary Habits
|
29.9 units on a scale
Standard Deviation 10.4
|
23.2 units on a scale
Standard Deviation 7.4
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: frequency analysis
Changes in depression symptom severity will be measured at baseline and post treatment (16 weeks) minimum-maximum total score range (0-24) Higher value represents greater depressive symptom severity An overall score was obtained from the 8-item measure.
Outcome measures
| Measure |
MH MOVE
n=19 Participants
provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions
MH MOVE: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions
|
Enhanced Usual Care
n=18 Participants
provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided.
Enhanced Usual Care: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided.
|
|---|---|---|
|
Assessing Depression Symptom Severity
|
6.3 units on a scale
Standard Deviation 7.1
|
13.4 units on a scale
Standard Deviation 6.2
|
SECONDARY outcome
Timeframe: 16 weeksAnxiety symptom severity will be measured by the GAD-7 at baseline and post treatment (16 weeks) minimum-maximum total score range (0-21) Higher value represents greater anxiety symptom severity An overall score was obtained from the 7-item measure.
Outcome measures
| Measure |
MH MOVE
n=19 Participants
provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions
MH MOVE: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions
|
Enhanced Usual Care
n=18 Participants
provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided.
Enhanced Usual Care: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided.
|
|---|---|---|
|
Assessing Anxiety Symptom Severity
|
5.5 units on a scale
Standard Deviation 6.5
|
10.5 units on a scale
Standard Deviation 6.7
|
SECONDARY outcome
Timeframe: 16 weeksPTSD symptom severity will be measured by the PCL-M at baseline and post treatment (16 weeks) minimum-maximum total score range (17-85) Higher value represents greater PTSD symptom severity An overall score was obtained from 4 subscales.
Outcome measures
| Measure |
MH MOVE
n=19 Participants
provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions
MH MOVE: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions
|
Enhanced Usual Care
n=18 Participants
provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided.
Enhanced Usual Care: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided.
|
|---|---|---|
|
Assessing PTSD Symptom Severity
|
32.1 units on a scale
Standard Deviation 20.8
|
53 units on a scale
Standard Deviation 18
|
SECONDARY outcome
Timeframe: baselineChanges in depression symptom severity will be measured at baseline and post treatment (16 weeks) minimum-maximum total score range (0-24) Higher value represents greater depressive symptom severity An overall score was obtained from the 8-item measure.
Outcome measures
| Measure |
MH MOVE
n=19 Participants
provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions
MH MOVE: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions
|
Enhanced Usual Care
n=18 Participants
provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided.
Enhanced Usual Care: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided.
|
|---|---|---|
|
Assessing Depression Symptom Severity
|
19 units on a scale
Standard Deviation 21.7
|
15 units on a scale
Standard Deviation 19.3
|
SECONDARY outcome
Timeframe: baselineAnxiety symptom severity will be measured by the GAD-7 at baseline and post treatment (16 weeks) minimum-maximum total score range (0-21) Higher value represents greater anxiety symptom severity An overall score was obtained from the 7-item measure.
Outcome measures
| Measure |
MH MOVE
n=19 Participants
provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions
MH MOVE: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions
|
Enhanced Usual Care
n=18 Participants
provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided.
Enhanced Usual Care: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided.
|
|---|---|---|
|
Assessing Anxiety Symptom Severity
|
8 units on a scale
Standard Deviation 13.8
|
16 units on a scale
Standard Deviation 19.7
|
SECONDARY outcome
Timeframe: baselinePTSD symptom severity will be measured by the PCL-M at baseline and post treatment (16 weeks) minimum-maximum total score range (17-85) Higher value represents greater PTSD symptom severity An overall score was obtained from 4 subscales.
Outcome measures
| Measure |
MH MOVE
n=19 Participants
provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions
MH MOVE: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 8 phone based clinician led CBT sessions
|
Enhanced Usual Care
n=18 Participants
provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided.
Enhanced Usual Care: provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided.
|
|---|---|---|
|
Assessing PTSD Symptom Severity
|
39 units on a scale
Standard Deviation 26.5
|
25 units on a scale
Standard Deviation 73.5
|
Adverse Events
MH MOVE
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Enhanced Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place