Using MOVE! With Seriously Mentally Ill Veterans
October 6, 2014 updated by: US Department of Veterans Affairs
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 Overview
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 Type
Interventional
Enrollment (Actual)
109
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Maryland
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Baltimore, Maryland, United States, 21201
- VA Maryland Health Care System, Baltimore
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
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group based psychoeducation, motivation and support
|
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No Intervention: Arm 2
The control group offers basic information about diet and exercise every month for six months.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weight Measurement
Time Frame: baseline and six months
|
Weight taken at the baseline assessment and again at the 6 month assessment
|
baseline and six months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
baseline and six months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Richard W Goldberg, PhD, VA Maryland Health Care System, Baltimore
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2006
Primary Completion (Actual)
January 1, 2010
Study Completion (Actual)
August 1, 2011
Study Registration Dates
First Submitted
May 5, 2006
First Submitted That Met QC Criteria
May 8, 2006
First Posted (Estimate)
May 9, 2006
Study Record Updates
Last Update Posted (Estimate)
October 9, 2014
Last Update Submitted That Met QC Criteria
October 6, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D4219-R
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.