Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Mental Illness Obesity Behavioral: MOVE! Not Applicable

Detailed Description:
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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Using MOVE! With Seriously Mentally Ill Veterans
Study Start Date : July 2006
Actual Primary Completion Date : January 2010
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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.
 Behavioral: MOVE!
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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Weight Measurement [ Time Frame: baseline and six months ]
    Weight taken at the baseline assessment and again at the 6 month assessment


Secondary Outcome Measures :
  1. Impact of Weight on Quality of Life Survey (IWQOL) [ Time Frame: baseline and six months ]
    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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • DSM- IV diagnosis of schizophrenia spectrum disorders OR a DSM-IV diagnosis of other severe mental disorder including bipolar disorder, major depression, or severe anxiety disorder;
  • Age between 18-64;
  • No psychiatric hospitalization in 3-month period prior to enrollment;
  • Community residency within 30 miles of either VA facility;
  • A BMI of 25 or higher;
  • Voluntary consent after receiving full information about the study;
  • English speaking;
  • Veteran of the armed forces

Exclusion Criteria:

  • Active cancer other than non-melanoma skin cancer
  • end stage chronic obstructive pulmonary disease
  • end stage congestive heart failure
  • end-stage neurological disorder
  • problematic substance abuse as defined by provider
  • end stage renal disease
  • moderate to severe cognitive impairment (dementia, post-stroke)
  • HIV positive with a CD4 count less than or equal to 350 within the last 6 months
  • anorexia
  • current pregnancy, currently nursing or planning to become pregnant in the next 6 months
  • those living in long-term care facilities
  • use in past 3 months of prescription pharmacological agents for weight loss
  • no chart documented VA delivered medical primary care or general somatic care visit within the last 18 months
  • most recent chart documented hematocrit level obtained within last six months is at or below 30%
  • most recent chart documented creatinine level obtained within the last six months that is at or above 2.5
  • most recent chart documented liver function tests obtained within the last six months exceeds twice the normal value for ALT, AST test in the Baltimore VA laboratory
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00323193


Locations
Layout table for location information
United States, Maryland
VA Maryland Health Care System, Baltimore
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
US Department of Veterans Affairs
Investigators
Layout table for investigator information
Principal Investigator: Richard W Goldberg, PhD VA Maryland Health Care System, Baltimore
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Layout table for additonal information
Responsible Party: US Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00323193    
Other Study ID Numbers: D4219-R
First Posted: May 9, 2006    Key Record Dates
Results First Posted: October 9, 2014
Last Update Posted: October 9, 2014
Last Verified: October 2014
Keywords provided by VA Office of Research and Development ( US Department of Veterans Affairs ):
Behavioral interventions
Mental Illness
Obesity
Psycho-educational interventions
Weight management
Additional relevant MeSH terms:
Layout table for MeSH terms
Mental Disorders