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Using MOVE! With Seriously Mentally Ill Veterans

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: NCT00323193
Recruitment Status : Completed
First Posted : May 9, 2006
Results First Posted : October 9, 2014
Last Update Posted : October 9, 2014
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label)
Conditions Mental Illness
Obesity
Intervention Behavioral: MOVE!
Enrollment 109
Recruitment Details  
Pre-assignment Details  
Arm/Group Title MOVE Group Control Group
Hide Arm/Group Description

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

The control group offers basic information about diet and exercise every month for six months.
Period Title: Overall Study
Started 53 56
Completed 30 41
Not Completed 23 15
Arm/Group Title MOVE Group Control Group Total
Hide Arm/Group Description

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

The control condition offers basic information about diet and exercise on a monthly basis. Total of all reporting groups
Overall Number of Baseline Participants 53 56 109
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 56 participants 109 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
53
 100.0%
54
  96.4%
107
  98.2%
>=65 years
0
   0.0%
2
   3.6%
2
   1.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 56 participants 109 participants
Female
13
  24.5%
8
  14.3%
21
  19.3%
Male
40
  75.5%
48
  85.7%
88
  80.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 56 participants 109 participants
American Indian or Alaska Native
0
   0.0%
1
   1.8%
1
   0.9%
Asian
0
   0.0%
1
   1.8%
1
   0.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
36
  67.9%
29
  51.8%
65
  59.6%
White
16
  30.2%
21
  37.5%
37
  33.9%
More than one race
1
   1.9%
4
   7.1%
5
   4.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 53 participants 56 participants 109 participants
53 56 109
1.Primary Outcome
Title Weight Measurement
Hide Description Weight taken at the baseline assessment and again at the 6 month assessment
Time Frame baseline and six months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MOVE Group Control Group
Hide Arm/Group Description:

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

The control group offers basic information about diet and exercise every month for six months.
Overall Number of Participants Analyzed 53 56
Mean (Standard Deviation)
Unit of Measure: pounds
Baseline Weight 237.2  (50.3) 230.2  (45.7)
6 Month follow up 240.8  (40.1) 228.1  (43.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MOVE Group, Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .720
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Secondary Outcome
Title Impact of Weight on Quality of Life Survey (IWQOL)
Hide Description Raw 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.
Time Frame baseline and six months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MOVE Group Control Group
Hide Arm/Group Description:

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

The control group offers basic information about diet and exercise every month for six months.
Overall Number of Participants Analyzed 53 56
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 67.6  (18.4) 73.5  (21.4)
6 Month Follow up 75.1  (15.7) 78.9  (19.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MOVE Group, Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .710
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse Events were reviewed for this study, although none were observed during the research trial.
 
Arm/Group Title MOVE Group Control Group
Hide Arm/Group Description

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

The control condition offers basic information about diet and exercise on a monthly basis.
All-Cause Mortality
MOVE Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
MOVE Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/56 (0.00%)   0/56 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
MOVE Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/53 (0.00%)   0/56 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Richard W. Goldberg, Ph.D.
Organization: VA VISN 5 Mental Illness Research, Education and Clinical Center
Phone: 410-637-1851
EMail: richard.goldberg@va.gov
Layout table for additonal information
Responsible Party: VA Office of Research and Development ( US Department of Veterans Affairs )
ClinicalTrials.gov Identifier: NCT00323193    
Other Study ID Numbers: D4219-R
First Submitted: May 5, 2006
First Posted: May 9, 2006
Results First Submitted: October 1, 2014
Results First Posted: October 9, 2014
Last Update Posted: October 9, 2014