| ID | Type | Description | Link |
|---|---|---|---|
| R01MH066068 | U.S. NIH Grant/Contract | View source | |
| DSIR 83-ATAP |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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This study will determine the effectiveness of a group-based behavioral program for weight reduction in overweight and obese schizophrenia patients.
Researchers have found a link between schizophrenia, high blood pressure, and insulin resistance; this link puts people with schizophrenia at an increased risk for diabetes and obesity. Weight reduction and maintenance is essential for decreasing these risks. Although data indicate that nonpharmacological interventions for weight loss are viable options, studies to determine their effectiveness have not been conducted. This study will determine the effectiveness of behavioral training for reducing weight in schizophrenia patients. This study will also determine the effects of weight reduction on cardiovascular risk factors in this population.
This study comprises two phases. In Phase 1, participants will be randomly assigned to receive either behavioral training or social skills training for 14 weeks. The behavioral training will teach participants ways to control their diet and increase their physical activity. The social skills training will teach participants how to indirectly control their weight by making social contacts and seeking social support. After 14 weeks, participants in the social skills training group and any participants who have not lost a specified amount of weight will complete the study; participants in the behavioral training group who have a 4% or more weight loss will be enrolled in Phase 2, a 24-month program designed to help participants maintain their weight loss. All participants in Phase 2 will continue to receive weekly behavioral training, but they will be randomly assigned to receive either behavioral training alone or behavioral training combined with biweekly booster treatments where participants discuss their response to different diet and exercise regimens and researchers discuss strategies for increasing one's success with the regimens. Interviews, self-report scales, and blood tests will be used to assess participants at study entry, after Phase 1, and at the end of the study. Assessments will include quality of life, self esteem, exercise frequency, blood pressure, serum lipids, and blood glucose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Phase 1 participants who will receive behavioral training for 14 weeks |
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| 2 | Active Comparator | Phase 1 participants who will receive social skills training for 14 weeks |
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| 3 | Experimental | Participants in the Phase 1 behavioral training group who have a 4% or more weight loss and will be enrolled in weekly behavioral training alone for 24 months in Phase 2 |
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| 4 | Experimental | Participants in the Phase 1 behavioral training group who have a 4% or more weight loss and will be enrolled in weekly behavioral training plus biweekly booster treatments for 24 months in Phase 2 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral training | Behavioral | The behavioral training will teach participants ways to control their diet and increase their physical activity. |
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| Measure | Description | Time Frame |
|---|---|---|
| Weight reduction | Measured at Week 14 and Month 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Weight maintenance | Measured at Week 14 and Month 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rohan Ganguli, MD | Western Psychiatric Institute and Clinic of University of Pennsylvania Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Western Psychiatric Institute and Clinic of University of Pennsylvania Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15705006 | Background | Brar JS, Ganguli R, Pandina G, Turkoz I, Berry S, Mahmoud R. Effects of behavioral therapy on weight loss in overweight and obese patients with schizophrenia or schizoaffective disorder. J Clin Psychiatry. 2005 Feb;66(2):205-12. doi: 10.4088/jcp.v66n0208. | |
| 11356587 | Background | Ganguli R, Brar JS, Ayrton Z. Weight gain over 4 months in schizophrenia patients: a comparison of olanzapine and risperidone. Schizophr Res. 2001 Apr 30;49(3):261-7. doi: 10.1016/s0920-9964(00)00080-3. |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D050177 | Overweight |
| D044343 | Overnutrition |
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| Social skills training | Behavioral | The social skills training will teach participants how to indirectly control their weight by making social contacts and seeking social support. |
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| Behavioral training booster sessions | Behavioral | During biweekly booster treatment sessions, participants will discuss their response to different diet and exercise regimens, and researchers will discuss strategies for increasing one's success with the regimens. |
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| 10548138 | Background | Ganguli R. Weight gain associated with antipsychotic drugs. J Clin Psychiatry. 1999;60 Suppl 21:20-4. |
| 23410710 | Derived | Janney CA, Ganguli R, Richardson CR, Holleman RG, Tang G, Cauley JA, Kriska AM. Sedentary behavior and psychiatric symptoms in overweight and obese adults with schizophrenia and schizoaffective disorders (WAIST Study). Schizophr Res. 2013 Apr;145(1-3):63-8. doi: 10.1016/j.schres.2013.01.010. Epub 2013 Feb 12. |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |