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: March 28, 2014
Last verified: March 2014

October 5, 2009
March 28, 2014
October 2009
February 2012   (final data collection date for primary outcome measure)
The primary outcome measure is change in body weight from baseline. [ Time Frame: 16 weeks, 6 month follow-up ] [ Designated as safety issue: No ]
The primary outcome measure is change in body weight from baseline. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00990925 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Change in lab values from baseline (fasting serum glucose, glycosylated hemoglobin, insulin, LDL cholesterol, triglyceride levels) [ Time Frame: 16 weeks ] [ 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 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Lifestyle Modification for Weight Loss in Schizophrenia
Lifestyle Modification for Weight Loss in Schizophrenia

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Obesity
  • Schizophrenia
  • Schizoaffective Disorder
  • 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.
  • Other: Usual Care
    Care as usual
    Other Name: Usual Care
  • Experimental: Weight Loss Education Group
    Involvement in weekly manualized, educational group on nutrition and lifestyle modifications to help with weight loss.
    Intervention: Behavioral: Nutritional Lifestyle Modification Group
  • Usual Care
    Treatment as usual
    Intervention: Other: Usual Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
149
February 2012
February 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00990925
0903004806, MH080048
No
Cenk Tek, Yale University
Yale University
Not Provided
Principal Investigator: Cenk Tek, M.D. Yale University
Yale University
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP