Trial Outcomes & Findings for Using MOVE! With Seriously Mentally Ill Veterans (NCT NCT00323193)
NCT ID: NCT00323193
Last Updated: 2014-10-09
Results Overview
Weight taken at the baseline assessment and again at the 6 month assessment
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
109 participants
Primary outcome timeframe
baseline and six months
Results posted on
2014-10-09
Participant Flow
Participant milestones
| Measure |
MOVE Group
The intervention group completes approximately 8 individual level sessions with a MOVE specialist as well as approximately 8 group level intervention sessions.
MOVE!: group based psychoeducation, motivation and support
|
Control Group
The control group offers basic information about diet and exercise every month for six months.
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
56
|
|
Overall Study
COMPLETED
|
30
|
41
|
|
Overall Study
NOT COMPLETED
|
23
|
15
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Using MOVE! With Seriously Mentally Ill Veterans
Baseline characteristics by cohort
| Measure |
MOVE Group
n=53 Participants
The intervention group completes approximately 8 individual level sessions with a MOVE specialist as well as approximately 8 group level intervention sessions.
MOVE!: group based psychoeducation, motivation and support
|
Control Group
n=56 Participants
The control condition offers basic information about diet and exercise on a monthly basis.
|
Total
n=109 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
53 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
107 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
88 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
36 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
65 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 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
|
|
Region of Enrollment
United States
|
53 participants
n=99 Participants
|
56 participants
n=107 Participants
|
109 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: baseline and six monthsWeight taken at the baseline assessment and again at the 6 month assessment
Outcome measures
| Measure |
MOVE Group
n=53 Participants
The intervention group completes approximately 8 individual level sessions with a MOVE specialist as well as approximately 8 group level intervention sessions.
MOVE!: group based psychoeducation, motivation and support
|
Control Group
n=56 Participants
The control group offers basic information about diet and exercise every month for six months.
|
|---|---|---|
|
Weight Measurement
Baseline Weight
|
237.2 pounds
Standard Deviation 50.3
|
230.2 pounds
Standard Deviation 45.7
|
|
Weight Measurement
6 Month follow up
|
240.8 pounds
Standard Deviation 40.1
|
228.1 pounds
Standard Deviation 43.4
|
SECONDARY outcome
Timeframe: baseline and six monthsRaw scores for this measure were converted to a range from 0 to 100, with higher scores indicating lower impact of weight on quality of life.
Outcome measures
| Measure |
MOVE Group
n=53 Participants
The intervention group completes approximately 8 individual level sessions with a MOVE specialist as well as approximately 8 group level intervention sessions.
MOVE!: group based psychoeducation, motivation and support
|
Control Group
n=56 Participants
The control group offers basic information about diet and exercise every month for six months.
|
|---|---|---|
|
Impact of Weight on Quality of Life Survey (IWQOL)
6 Month Follow up
|
75.1 units on a scale
Standard Deviation 15.7
|
78.9 units on a scale
Standard Deviation 19.1
|
|
Impact of Weight on Quality of Life Survey (IWQOL)
Baseline
|
67.6 units on a scale
Standard Deviation 18.4
|
73.5 units on a scale
Standard Deviation 21.4
|
Adverse Events
MOVE Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
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
Richard W. Goldberg, Ph.D.
VA VISN 5 Mental Illness Research, Education and Clinical Center
Phone: 410-637-1851
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place