Using MOVE! With Seriously Mentally Ill Veterans

Obesity Clinical Trial

Official title:

Using MOVE! With Seriously Mentally Ill Veterans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00323193
• Other study ID #: D4219-R
• Status: Completed
• Phase: N/A
• First received: May 5, 2006
• Last updated: October 6, 2014
• Start date: July 2006
• Est. completion date: August 2011

Study information

• Verified date: October 2014
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: August 2011
• Est. primary completion date: January 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Mental Disorders
• Mental Illness
• Obesity

Intervention

Behavioral:
• MOVE!
group based psychoeducation, motivation and support

Locations

Country	Name	City	State
United States	VA Maryland Health Care System, Baltimore	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

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.2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight Measurement	Weight taken at the baseline assessment and again at the 6 month assessment	baseline and six months	No
Secondary	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	No