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Using MOVE! With Seriously Mentally Ill Veterans

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00323193
First received: May 5, 2006
Last updated: October 6, 2014
Last verified: October 2014
  Purpose

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 Intervention
Mental Illness
Obesity
Behavioral: MOVE!

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Using MOVE! With Seriously Mentally Ill Veterans

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Enrollment: 109
Study Start Date: July 2006
Study Completion Date: August 2011
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00323193

Locations
United States, Maryland
VA Maryland Health Care System, Baltimore
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Investigators
Principal Investigator: Richard W Goldberg, PhD VA Maryland Health Care System, Baltimore
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00323193     History of Changes
Other Study ID Numbers: D4219-R
Study First Received: May 5, 2006
Results First Received: October 1, 2014
Last Updated: October 6, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Behavioral interventions
Mental Illness
Obesity
Psycho-educational interventions
Weight management

Additional relevant MeSH terms:
Mental Disorders
Obesity
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on November 27, 2014