Western Psychiatric Institute and Clinic of University of Pennsylvania Medical Center
Pittsburgh, Pennsylvania, 15213, United States
NCT Number: NCT00158366
This study will determine the effectiveness of a group-based behavioral program for weight reduction in overweight and obese schizophrenia patients.
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Notify Me14 year–60 year
All sexes
Interventional
Not applicable
Pittsburgh, Pennsylvania, 15213, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Measured at Week 14 and Month 24
Time frame: Measured at Week 14 and Month 24
University of Pittsburgh
Other
A Clinical Trial Of Weight Reduction in Schizophrenia
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