Using MOVE! With Seriously Mentally Ill Veterans

• Sponsor: US Department of Veterans Affairs (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00323193
• Collaborator: (none)
• Enrollment: 109
• Location: 1
• Arms: 2
• Duration (Months): 61
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mental Illness; Obesity	Behavioral: MOVE!	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 109 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Official Title: Using MOVE! With Seriously Mentally Ill Veterans
• Study Start Date: Jul 1, 2006
• Actual Primary Completion Date: Jan 1, 2010
• Actual Study Completion Date: Aug 1, 2011

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Weight Measurement [baseline and six months]

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

Secondary Outcome Measures

1. Impact of Weight on Quality of Life Survey (IWQOL) [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Maryland Health Care System, Baltimore	Baltimore	Maryland	United States	21201

Sponsors and Collaborators

• US Department of Veterans Affairs

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: US Department of Veterans Affairs
• ClinicalTrials.gov Identifier: NCT00323193
• Other Study ID Numbers: D4219-R
• First Posted: May 9, 2006
• Last Update Posted: Oct 9, 2014
• Last Verified: Oct 1, 2014

• Keywords provided by US Department of Veterans Affairs: Behavioral interventions; Mental Illness; Obesity; Psycho-educational interventions; Weight management
• Additional relevant MeSH terms: Mental Disorders

Study Results

Participant Flow

Arm/Group Title	MOVE Group	Control Group
Arm/Group Description	The intervention group completes approximately 8 individual level sessions with a MOVE specialist as well as approximately 8 group level intervention sessions. MOVE!: group based psychoeducation, motivation and support	The control group offers basic information about diet and exercise every month for six months.
Period Title: Overall Study
STARTED	53	56
COMPLETED	30	41
NOT COMPLETED	23	15

Baseline Characteristics

Arm/Group Title	MOVE Group	Control Group	Total
Arm/Group Description	The intervention group completes approximately 8 individual level sessions with a MOVE specialist as well as approximately 8 group level intervention sessions. MOVE!: group based psychoeducation, motivation and support	The control condition offers basic information about diet and exercise on a monthly basis.	Total of all reporting groups
Overall Participants	53	56	109
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	53 100%	54 96.4%	107 98.2%
>=65 years	0 0%	2 3.6%	2 1.8%
Sex: Female, Male (Count of Participants)
Female	13 24.5%	8 14.3%	21 19.3%
Male	40 75.5%	48 85.7%	88 80.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	1 1.8%	1 0.9%
Asian	0 0%	1 1.8%	1 0.9%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	36 67.9%	29 51.8%	65 59.6%
White	16 30.2%	21 37.5%	37 33.9%
More than one race	1 1.9%	4 7.1%	5 4.6%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	53 100%	56 100%	109 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MOVE Group	Control Group
Arm/Group Description	The intervention group completes approximately 8 individual level sessions with a MOVE specialist as well as approximately 8 group level intervention sessions. MOVE!: group based psychoeducation, motivation and support	The control group offers basic information about diet and exercise every month for six months.
Measure Participants	53	56
Baseline Weight	237.2 (50.3)	230.2 (45.7)
6 Month follow up	240.8 (40.1)	228.1 (43.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	MOVE Group, Control Group
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.720
	Comments
	Method	ANOVA
	Comments

2. Secondary Outcome

Title	Impact of Weight on Quality of Life Survey (IWQOL)
Description	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.
Time Frame	baseline and six months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MOVE Group	Control Group
Arm/Group Description	The intervention group completes approximately 8 individual level sessions with a MOVE specialist as well as approximately 8 group level intervention sessions. MOVE!: group based psychoeducation, motivation and support	The control group offers basic information about diet and exercise every month for six months.
Measure Participants	53	56
Baseline	67.6 (18.4)	73.5 (21.4)
6 Month Follow up	75.1 (15.7)	78.9 (19.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	MOVE Group, Control Group
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.710
	Comments
	Method	ANOVA
	Comments

Adverse Events

Adverse Event Reporting Description	Adverse Events were reviewed for this study, although none were observed during the research trial.
Arm/Group Title	MOVE Group		Control Group
Arm/Group Description	The intervention group completes approximately 8 individual level sessions with a MOVE specialist as well as approximately 8 group level intervention sessions. MOVE!: group based psychoeducation, motivation and support		The control condition offers basic information about diet and exercise on a monthly basis.
All Cause Mortality
	MOVE Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	MOVE Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/56 (0%)		0/56 (0%)
Other (Not Including Serious) Adverse Events
	MOVE Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/53 (0%)		0/56 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.