Using MOVE! With Seriously Mentally Ill Veterans

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Using MOVE! With Seriously Mentally Ill Veterans

Conditions
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Obesity, Mental Illness

Intervention / Treatment
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* Behavioral: MOVE!


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>The intervention group completes approximately 8 individual level sessions with a MOVE specialist as well as approximately 8 group level intervention sessions. | Behavioral: MOVE!<br>* group based psychoeducation, motivation and support<br>|
| No Intervention: Arm 2<br>The control group offers basic information about diet and exercise every month for six months. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Measurement | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Behavioral interventions, Mental Illness, Obesity, Psycho-educational interventions, Weight management