Back to resultsLifestyle Modification for Weight Loss in Schizophrenia
Primary Purpose
Obesity, Schizophrenia, Schizoaffective Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nutritional Lifestyle Modification Group
Usual Care
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Obesity, Schizophrenia, Schizoaffective disorder, weight loss
Eligibility Criteria
Inclusion Criteria:
- Subjects will be between 18 and 65 years of age.
- Have a BMI of 28 or greater.
- Meet DSM-IV criteria for schizophrenia or schizoaffective disorder.
- 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:
- A history of dementia or mental retardation.
- Not capable of giving informed consent for participation in this study.
- Ongoing pregnancy.
- Living in a structured environment where the meals are provided as part of the program, e.g., a group home, nursing home, etc.
Sites / Locations
- Connecticut Mental Health Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Weight Loss Education Group
Usual Care
Arm Description
Involvement in weekly manualized, educational group on nutrition and lifestyle modifications to help with weight loss.
Treatment as usual
Outcomes
Primary Outcome Measures
The primary outcome measure is change in body weight from baseline.
Secondary Outcome Measures
Change in lab values from baseline (fasting serum glucose, glycosylated hemoglobin, insulin, LDL cholesterol, triglyceride levels)
Change in questionnaires and assessments (Q-LES-Q, QLS, PANSS, Food craving scales, Food frequency scales, Food preference scales)
Full Information
NCT ID
NCT00990925
First Posted
October 5, 2009
Last Updated
November 4, 2015
Sponsor
Yale University
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00990925
Brief Title
Lifestyle Modification for Weight Loss in Schizophrenia
Official Title
Lifestyle Modification for Weight Loss in Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yale University
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Schizophrenia, Schizoaffective Disorder
Keywords
Obesity, Schizophrenia, Schizoaffective disorder, weight loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
149 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Weight Loss Education Group
Arm Type
Experimental
Arm Description
Involvement in weekly manualized, educational group on nutrition and lifestyle modifications to help with weight loss.
Arm Title
Usual Care
Arm Type
Other
Arm Description
Treatment as usual
Intervention Type
Behavioral
Intervention Name(s)
Nutritional Lifestyle Modification Group
Intervention Description
Manualized group treatment to educate about basic nutritional concepts to help improve eating choices with the goal of losing weight.
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Care as usual
Primary Outcome Measure Information:
Title
The primary outcome measure is change in body weight from baseline.
Time Frame
16 weeks, 6 month follow-up
Secondary Outcome Measure Information:
Title
Change in lab values from baseline (fasting serum glucose, glycosylated hemoglobin, insulin, LDL cholesterol, triglyceride levels)
Time Frame
16 weeks, 6 month follow-up
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects will be between 18 and 65 years of age.
Have a BMI of 28 or greater.
Meet DSM-IV criteria for schizophrenia or schizoaffective disorder.
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:
A history of dementia or mental retardation.
Not capable of giving informed consent for participation in this study.
Ongoing pregnancy.
Living in a structured environment where the meals are provided as part of the program, e.g., a group home, nursing home, etc.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cenk Tek, M.D.
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Connecticut Mental Health Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Lifestyle Modification for Weight Loss in Schizophrenia
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