Using MOVE! With Seriously Mentally Ill Veterans

• 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: US Department of Veterans Affairs
• Information provided by (Responsible Party): VA Office of Research and Development ( US Department of Veterans Affairs )

Tracking Information

• First Submitted Date: May 5, 2006
• First Posted Date: May 9, 2006
• Results First Submitted Date: October 1, 2014
• Results First Posted Date: October 9, 2014
• Last Update Posted Date: October 9, 2014
• Study Start Date: July 2006
• Actual Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 6, 2014)

Weight Measurement [ Time Frame: baseline and six months ]

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

• Original Primary Outcome Measures (submitted: May 8, 2006): 4% or higher weight loss, mean weight loss, and reductions in cardiovascular risk (blood pressure, glucose and serum lipids). For the full sample, weight is measured at baseline and monthly.

Current Secondary Outcome Measures (submitted: October 6, 2014)

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.

Original Secondary Outcome Measures (submitted: May 8, 2006)

• Physical activity, dietary management, self-efficacy, and motivation/readiness to change at baseline and at 6-months.
• Exploratory analyses will also examine covariates to include substance abuse, cigarette smoking, neurocognition.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Using MOVE! With Seriously Mentally Ill Veterans
• Official Title: Using MOVE! With Seriously Mentally Ill Veterans
• 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.
• 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
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label)

Condition

• Mental Illness
• Obesity

Intervention

Behavioral: MOVE!

group based psychoeducation, motivation and support

Study Arms

• 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.
  Intervention: Behavioral: MOVE!
• No Intervention: Arm 2
  The control group offers basic information about diet and exercise every month for six months.

• Publications *: Goldberg RW, Reeves G, Tapscott S, Medoff D, Dickerson F, Goldberg AP, Ryan AS, Fang LJ, Dixon LB. "MOVE!" Outcomes of a weight loss program modified for veterans with serious mental illness. Psychiatr Serv. 2013 Aug 1;64(8):737-44. doi: 10.1176/appi.ps.201200314.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 6, 2014): 109
• Original Enrollment (submitted: May 8, 2006): 200
• Actual Study Completion Date: August 2011
• Actual Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00323193
• Other Study ID Numbers: D4219-R
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: VA Office of Research and Development ( US Department of Veterans Affairs )
• Study Sponsor: US Department of Veterans Affairs
• Collaborators: Not Provided

Investigators

• Principal Investigator: Richard W Goldberg, PhD; VA Maryland Health Care System, Baltimore

• PRS Account: VA Office of Research and Development
• Verification Date: October 2014