Lifestyle Modification for Weight Loss in Schizophrenia

This study has been completed.
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Cenk Tek, Yale University Identifier:
First received: October 5, 2009
Last updated: November 4, 2015
Last verified: November 2015
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
Schizoaffective Disorder
Behavioral: Nutritional Lifestyle Modification Group
Other: Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Yale University:

Primary Outcome Measures:
  • The primary outcome measure is change in body weight from baseline. [ Time Frame: 16 weeks, 6 month follow-up ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00990925

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

Responsible Party: Cenk Tek, Associate Professor, Yale University Identifier: NCT00990925     History of Changes
Other Study ID Numbers: 0903004806  R01MH080048 
Study First Received: October 5, 2009
Last Updated: November 4, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
Schizoaffective disorder
weight loss

Additional relevant MeSH terms:
Psychotic Disorders
Weight Loss
Body Weight
Body Weight Changes
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Signs and Symptoms processed this record on May 05, 2016