NCT00323193

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 5, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 9, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2006

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

October 9, 2014

Completed
Last Updated

October 9, 2014

Status Verified

October 1, 2014

Enrollment Period

3.5 years

First QC Date

May 5, 2006

Results QC Date

October 1, 2014

Last Update Submit

October 6, 2014

Conditions

Mental IllnessObesity

Keywords

Behavioral interventionsMental IllnessObesityPsycho-educational interventionsWeight management

Outcome Measures

Primary Outcomes (1)

  • Weight Measurement

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

    baseline and six months

Secondary Outcomes (1)

  • Impact of Weight on Quality of Life Survey (IWQOL)

    baseline and six months

Study Arms (2)

Arm 1

EXPERIMENTAL

The intervention group completes approximately 8 individual level sessions with a MOVE specialist as well as approximately 8 group level intervention sessions.

Behavioral: MOVE!

Arm 2

NO INTERVENTION

The control group offers basic information about diet and exercise every month for six months.

Interventions

MOVE!BEHAVIORAL

group based psychoeducation, motivation and support

Arm 1

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Maryland Health Care System, Baltimore

Baltimore, Maryland, 21201, United States

Location

Related 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.201200314.

    PMID: 23584716RESULT

MeSH Terms

Conditions

Mental DisordersObesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Richard W. Goldberg, Ph.D.
Organization
VA VISN 5 Mental Illness Research, Education and Clinical Center
richard.goldberg@va.gov
410-637-1851

Study Officials

  • Richard W Goldberg, PhD

    VA Maryland Health Care System, Baltimore

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2006

First Posted

May 9, 2006

Study Start

July 1, 2006

Primary Completion

January 1, 2010

Study Completion

August 1, 2011

Last Updated

October 9, 2014

Results First Posted

October 9, 2014

Record last verified: 2014-10

Locations

US(1)