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Lifestyle Modification for Weight Loss in Schizophrenia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cenk Tek, Yale University
ClinicalTrials.gov Identifier:
NCT00990925
First received: October 5, 2009
Last updated: June 4, 2013
Last verified: June 2013
History of Changes
  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
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:

U.S. FDA Resources

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
Other Name: Usual Care

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00990925

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

No publications provided

Responsible Party: Cenk Tek, Associate Professor, Yale University
ClinicalTrials.gov Identifier: NCT00990925     History of Changes
Other Study ID Numbers: 0903004806, MH080048
Study First Received: October 5, 2009
Last Updated: June 4, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Obesity
Psychotic Disorders
Schizophrenia
Weight Loss
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Body Weight Changes

ClinicalTrials.gov processed this record on June 13, 2013