Using MOVE! With Seriously Mentally Ill Veterans

October 6, 2014 updated by: US Department of Veterans Affairs
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

109

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • VA Maryland Health Care System, Baltimore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: MOVE!
group based psychoeducation, motivation and support
No Intervention: Arm 2
The control group offers basic information about diet and exercise every month for six months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight Measurement
Time Frame: baseline and six months
Weight taken at the baseline assessment and again at the 6 month assessment
baseline and six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline and six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

US Department of Veterans Affairs

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

May 5, 2006

First Submitted That Met QC Criteria

May 8, 2006

First Posted (Estimate)

May 9, 2006

Study Record Updates

Last Update Posted (Estimate)

October 9, 2014

Last Update Submitted That Met QC Criteria

October 6, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D4219-R

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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