Using MOVE! With Seriously Mentally Ill Veterans
This study involves a controlled trial of an optimized version of a weight management and physical activity psycho-educational intervention (called MOVE!) with 200 obese and overweight veterans with serious mental illness.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
|Official Title:||Using MOVE! With Seriously Mentally Ill Veterans|
- Weight Measurement [ Time Frame: baseline and six months ] [ Designated as safety issue: No ]Weight taken at the baseline assessment and again at the 6 month assessment
- Impact of Weight on Quality of Life Survey (IWQOL) [ Time Frame: baseline and six months ] [ Designated as safety issue: No ]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.
|Study Start Date:||July 2006|
|Study Completion Date:||August 2011|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
Experimental: Arm 1
The intervention group completes approximately 8 individual level sessions with a MOVE specialist as well as approximately 8 group level intervention sessions.
group based psychoeducation, motivation and support
No Intervention: Arm 2
The control group offers basic information about diet and exercise every month for six months.
This study involves a controlled trial of an optimized version of a weight management and physical activity psycho-educational intervention (called MOVE!) for overweight and obese Veterans with serious mental illness. The study hypothesizes that MOVE! will result in weight loss and improved indicators of cardiovascular risk when compared to usual care. Medical outcomes are proportion achieving 4% or higher weight loss, mean weight loss, and reductions in cardiovascular risk (blood pressure, glucose and serum lipids). Psychosocial outcomes are general health, psychiatric functioning, quality of life, and self-esteem and medication adherence. Mediators include physical activity, dietary management, self-efficacy, and motivation/readiness to change. The intervention involves a well specified combination of individualized and group based services and draws on evidence based techniques and materials that are currently well packaged in an existing VA program called MOVE! The Comparison condition is operationalized as usual treatment plus monthly weight measurements and distribution of educational brochures regarding diet and exercise.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00323193
|United States, Maryland|
|VA Maryland Health Care System, Baltimore|
|Baltimore, Maryland, United States, 21201|
|Principal Investigator:||Richard W Goldberg, PhD||VA Maryland Health Care System, Baltimore|