Lifestyle Modification for Weight Loss in Schizophrenia
2 other identifiers
interventional
149
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable obesity
Started Oct 2009
Typical duration for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 5, 2009
CompletedFirst Posted
Study publicly available on registry
October 7, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedNovember 5, 2015
November 1, 2015
2.3 years
October 5, 2009
November 4, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary outcome measure is change in body weight from baseline.
16 weeks, 6 month follow-up
Secondary Outcomes (2)
Change in lab values from baseline (fasting serum glucose, glycosylated hemoglobin, insulin, LDL cholesterol, triglyceride levels)
16 weeks, 6 month follow-up
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
Study Arms (2)
Weight Loss Education Group
EXPERIMENTALInvolvement in weekly manualized, educational group on nutrition and lifestyle modifications to help with weight loss.
Usual Care
OTHERTreatment as usual
Interventions
Manualized group treatment to educate about basic nutritional concepts to help improve eating choices with the goal of losing weight.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
- National Institute of Mental Health (NIMH)collaborator
Study Sites (1)
Connecticut Mental Health Center
New Haven, Connecticut, 06519, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cenk Tek, M.D.
Yale University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
October 5, 2009
First Posted
October 7, 2009
Study Start
October 1, 2009
Primary Completion
February 1, 2012
Study Completion
February 1, 2012
Last Updated
November 5, 2015
Record last verified: 2015-11