N/A N=109 Randomized

Using MOVE! With Seriously Mentally Ill Veterans

Mental Illness · Obesity

Bottom Line

View on ClinicalTrials.gov: NCT00323193 ↗

Enrolled (actual)

109

Serious AEs

0.0%

Results posted

Oct 2014

Primary outcome: Primary: Weight Measurement — 237.2; 230.2; 240.8; 228.1 pounds — p=.720

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: MOVE! (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: US Department of Veterans Affairs
Primary completion: Jan 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Weight Measurement	237.2; 230.2; 240.8; 228.1	.720
SECONDARY Impact of Weight on Quality of Life Survey (IWQOL)	67.6; 73.5; 75.1; 78.9	.710

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00323193). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.