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Lifestyle Modification for Weight Loss in Schizophrenia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00990925
First Posted: October 7, 2009
Last Update Posted: November 5, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Cenk Tek, Yale University
  Purpose
The purpose of this study is to find out how effective lifestyle modification group therapy is on reducing body weight when compared to usual care in individuals with schizophrenia and/or schizoaffective disorder.

Condition Intervention
Obesity Schizophrenia Schizoaffective Disorder Behavioral: Nutritional Lifestyle Modification Group Other: Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lifestyle Modification for Weight Loss in Schizophrenia

Resource links provided by NLM:


Further study details as provided by Cenk Tek, Yale University:

Primary Outcome Measures:
  • The primary outcome measure is change in body weight from baseline. [ Time Frame: 16 weeks, 6 month follow-up ]

Secondary Outcome Measures:
  • Change in lab values from baseline (fasting serum glucose, glycosylated hemoglobin, insulin, LDL cholesterol, triglyceride levels) [ Time Frame: 16 weeks, 6 month follow-up ]
  • Change in questionnaires and assessments (Q-LES-Q, QLS, PANSS, Food craving scales, Food frequency scales, Food preference scales) [ Time Frame: 16 weeks, 6 month follow-up ]

Enrollment: 149
Study Start Date: October 2009
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Weight Loss Education Group
Involvement in weekly manualized, educational group on nutrition and lifestyle modifications to help with weight loss.
Behavioral: Nutritional Lifestyle Modification Group
Manualized group treatment to educate about basic nutritional concepts to help improve eating choices with the goal of losing weight.
Usual Care
Treatment as usual
Other: Usual Care
Care as usual

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects will be between 18 and 65 years of age.
  2. Have a BMI of 28 or greater.
  3. Meet DSM-IV criteria for schizophrenia or schizoaffective disorder.
  4. Be on a stable dose of antipsychotic medication for at least one month, with positive symptoms stability as judged by the clinical team and investigator.

Exclusion Criteria:

  1. A history of dementia or mental retardation.
  2. Not capable of giving informed consent for participation in this study.
  3. Ongoing pregnancy.
  4. Living in a structured environment where the meals are provided as part of the program, e.g., a group home, nursing home, etc.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00990925


Locations
United States, Connecticut
Connecticut Mental Health Center
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Cenk Tek, M.D. Yale University
  More Information

Responsible Party: Cenk Tek, Associate Professor, Yale University
ClinicalTrials.gov Identifier: NCT00990925     History of Changes
Other Study ID Numbers: 0903004806
R01MH080048 ( U.S. NIH Grant/Contract )
First Submitted: October 5, 2009
First Posted: October 7, 2009
Last Update Posted: November 5, 2015
Last Verified: November 2015

Keywords provided by Cenk Tek, Yale University:
Obesity
Schizophrenia
Schizoaffective disorder
weight loss

Additional relevant MeSH terms:
Schizophrenia
Weight Loss
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Body Weight Changes
Body Weight
Signs and Symptoms