Obesity, Schizoaffective Disorder, Schizophrenia
Conditions
Keywords
Obesity, Schizophrenia, Schizoaffective disorder, weight loss
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.
Interventions
BEHAVIORALNutritional Lifestyle Modification Group
Manualized group treatment to educate about basic nutritional concepts to help improve eating choices with the goal of losing weight.
OTHERUsual Care
Care as usual
Sponsors
National Institute of Mental Health (NIMH)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure is change in body weight from baseline. | 16 weeks, 6 month follow-up |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed