Clinical trial NCT00323193: Using MOVE! With Seriously Mentally Ill Veterans
Official title: Using MOVE! With Seriously Mentally Ill Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Illness
Obesity
Keywords: Behavioral interventions
Mental Illness
Obesity
Psycho-educational interventions
Weight management
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2006-05-09
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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

Primary outcomes:
measure: Weight Measurement
timeFrame: baseline and six months
Secondary outcomes:
measure: Impact of Weight on Quality of Life Survey (IWQOL)
timeFrame: baseline and six months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: VA Maryland Health Care System, Baltimore
state: Maryland
Study officials:
affiliation: VA Maryland Health Care System, Baltimore
name: Richard W Goldberg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.