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Completed

NCT Number: NCT00323193

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Maryland Health Care System, Baltimore

Baltimore, Maryland, 21201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MOVE!

Behavioral

group based psychoeducation, motivation and support

Primary outcomes

  1. Weight Measurement

    Time frame: baseline and six months

    Weight taken at the baseline assessment and again at the 6 month assessment

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

US Department of Veterans Affairs

Fed

Registry information

Important dates

Study start
2006
Primary completion
2010
Study completion
2011
First posted
May 9, 2006
Registry last updated
Oct 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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