An interventional study of Behavioral training and Social skills training in Schizophrenia and Obesity, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to participants aged 14 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-08-22.
Sponsored by University of Pittsburgh · Not applicable, Interventional, and Treatment
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.
3,470 studies on the registry are indexed under Schizophrenia; 471 are open to participants now.
This study's enrollment of 261 is above the median of 70 across 2,871 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →University of Pittsburgh is the lead sponsor of 1,384 studies on the registry; 166 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
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Exclusion Criteria:
Phase 1 participants who will receive behavioral training for 14 weeks
Behavioral: Behavioral training
Phase 1 participants who will receive social skills training for 14 weeks
Behavioral: Social skills training
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
Behavioral: Behavioral training
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
Behavioral: Behavioral training booster sessions
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.
Weight reduction
Time frame: Measured at Week 14 and Month 24
Weight maintenance
Time frame: Measured at Week 14 and Month 24
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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