Reducing the Weight of Overweight Schizophrenia Patients - Full Text View

Sponsor:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00158366

Purpose

This study will determine the effectiveness of a group-based behavioral program for weight reduction in overweight and obese schizophrenia patients.

Condition	Intervention
Schizophrenia Obesity	Behavioral: Behavioral training Behavioral: Social skills training Behavioral: Behavioral training booster sessions

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Clinical Trial Of Weight Reduction in Schizophrenia

Resource links provided by NLM:

MedlinePlus related topics: Obesity Obesity in Children Schizophrenia Weight Control

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

Weight reduction [ Time Frame: Measured at Week 14 and Month 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Weight maintenance [ Time Frame: Measured at Week 14 and Month 24 ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	May 2004
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Phase 1 participants who will receive behavioral training for 14 weeks	Behavioral: Behavioral training The behavioral training will teach participants ways to control their diet and increase their physical activity.
2: Active Comparator Phase 1 participants who will receive social skills training for 14 weeks	Behavioral: Social skills training The social skills training will teach participants how to indirectly control their weight by making social contacts and seeking social support.
3: Experimental Participants in the Phase 1 behavioral training group who have a 4% or more weight loss and will be enrolled in weekly behavioral training alone for 24 months in Phase 2	Behavioral: Behavioral training The behavioral training will teach participants ways to control their diet and increase their physical activity.
4: Experimental Participants in the Phase 1 behavioral training group who have a 4% or more weight loss and will be enrolled in weekly behavioral training plus biweekly booster treatments for 24 months in Phase 2	Behavioral: Behavioral training booster sessions During biweekly booster treatment sessions, participants will discuss their response to different diet and exercise regimens, and researchers will discuss strategies for increasing one's success with the regimens.

Detailed Description:

Researchers have found a link between schizophrenia, high blood pressure, and insulin resistance; this link puts people with schizophrenia at an increased risk for diabetes and obesity. Weight reduction and maintenance is essential for decreasing these risks. Although data indicate that nonpharmacological interventions for weight loss are viable options, studies to determine their effectiveness have not been conducted. This study will determine the effectiveness of behavioral training for reducing weight in schizophrenia patients. This study will also determine the effects of weight reduction on cardiovascular risk factors in this population.

This study comprises two phases. In Phase 1, participants will be randomly assigned to receive either behavioral training or social skills training for 14 weeks. The behavioral training will teach participants ways to control their diet and increase their physical activity. The social skills training will teach participants how to indirectly control their weight by making social contacts and seeking social support. After 14 weeks, participants in the social skills training group and any participants who have not lost a specified amount of weight will complete the study; participants in the behavioral training group who have a 4% or more weight loss will be enrolled in Phase 2, a 24-month program designed to help participants maintain their weight loss. All participants in Phase 2 will continue to receive weekly behavioral training, but they will be randomly assigned to receive either behavioral training alone or behavioral training combined with biweekly booster treatments where participants discuss their response to different diet and exercise regimens and researchers discuss strategies for increasing one's success with the regimens. Interviews, self-report scales, and blood tests will be used to assess participants at study entry, after Phase 1, and at the end of the study. Assessments will include quality of life, self esteem, exercise frequency, blood pressure, serum lipids, and blood glucose.

Eligibility

Ages Eligible for Study:	14 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of schizophrenia or schizoaffective disorder
Body mass index (BMI) greater than 27
Stable on antipsychotic drug regimen for at least 1 month prior to study entry
Parent or guardian willing to provide informed consent, if applicable
Positive and negative syndrome scale score less than 90
Willing to use acceptable methods of contraception during the study

Exclusion Criteria:

Medical contraindication for participating in a weight reduction/exercise program
Mental retardation
Current enrollment in another weight management program
Current use of weight reduction medication
Unstable cardiovascular or thyroid disease
Active or end-stage renal disease
Psychiatric hospitalization within 1 month prior to study entry
Current use of more than one anti-psychotic medication
Pregnancy or breastfeeding

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00158366

Locations

United States, Pennsylvania
Western Psychiatric Institute and Clinic of University of Pennsylvania Medical Center
Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:	Jaspreet Brar, MBBS, MPH	Western Psychiatric Institute and Clinic of University of Pennsylvania Medical Center
Principal Investigator:	Rohan Ganguli, MD	Western Psychiatric Institute and Clinic of University of Pennsylvania Medical Center

More Information

Additional Information:

Click here for more information about the Schizophrenia and Wellness Research Program This link exits the ClinicalTrials.gov site

Publications:

Brar JS, Ganguli R, Pandina G, Turkoz I, Berry S, Mahmoud R. Effects of behavioral therapy on weight loss in overweight and obese patients with schizophrenia or schizoaffective disorder. J Clin Psychiatry. 2005 Feb;66(2):205-12.

Ganguli R, Brar JS, Ayrton Z. Weight gain over 4 months in schizophrenia patients: a comparison of olanzapine and risperidone. Schizophr Res. 2001 Apr 30;49(3):261-7.

Ganguli R. Weight gain associated with antipsychotic drugs. J Clin Psychiatry. 1999;60 Suppl 21:20-4.

Responsible Party:	University of Pittsburgh ( Rohan Ganguli )
Study ID Numbers:	R01 MH66068, DSIR 83-ATAP
Study First Received:	September 7, 2005
Last Updated:	September 18, 2008
ClinicalTrials.gov Identifier:	NCT00158366 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Weight Loss

Additional relevant MeSH terms:

Body Weight
Schizophrenia
Signs and Symptoms
Obesity
Mental Disorders

Nutrition Disorders
Overweight
Overnutrition
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on November 09, 2009