Lifestyle Modification for Weight Loss in Schizophrenia

Obesity Clinical Trial

Official title:

Lifestyle Modification for Weight Loss in Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00990925
• Other study ID #: 0903004806
• Secondary ID: R01MH080048
• Status: Completed
• Phase: N/A
• First received: October 5, 2009
• Last updated: November 4, 2015
• Start date: October 2009
• Est. completion date: February 2012

Study information

• Verified date: November 2015
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia
• Weight Loss

Intervention

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

Locations

Country	Name	City	State
United States	Connecticut Mental Health Center	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome measure is change in body weight from baseline.		16 weeks, 6 month follow-up	No
Secondary	Change in lab values from baseline (fasting serum glucose, glycosylated hemoglobin, insulin, LDL cholesterol, triglyceride levels)		16 weeks, 6 month follow-up	No
Secondary	Change in questionnaires and assessments (Q-LES-Q, QLS, PANSS, Food craving scales, Food frequency scales, Food preference scales)		16 weeks, 6 month follow-up	No