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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH080048 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Weight Loss Education Group | Experimental | Involvement in weekly manualized, educational group on nutrition and lifestyle modifications to help with weight loss. |
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| Usual Care | Other | Treatment as usual |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutritional Lifestyle Modification Group | Behavioral | Manualized group treatment to educate about basic nutritional concepts to help improve eating choices with the goal of losing weight. |
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome measure is change in body weight from baseline. | 16 weeks, 6 month follow-up |
| Measure | Description | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cenk Tek, M.D. | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Connecticut Mental Health Center | New Haven | Connecticut | 06519 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Usual Care | Other | Care as usual |
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| 16 weeks, 6 month follow-up |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D001836 | Body Weight Changes |