NCT00990925已完成不适用
Lifestyle Modification for Weight Loss in Schizophrenia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 149
- 试验地点
- 2
- 主要终点
- The primary outcome measure is change in body weight from baseline.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects will be between 18 and 65 years of age.
- •Have a BMI of 28 or greater.
- •Meet DSM-IV criteria for schizophrenia or schizoaffective disorder.
- •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.
排除标准
- •A history of dementia or mental retardation.
- •Not capable of giving informed consent for participation in this study.
- •Ongoing pregnancy.
- •Living in a structured environment where the meals are provided as part of the program, e.g., a group home, nursing home, etc.
结局指标
主要结局
The primary outcome measure is change in body weight from baseline.
时间窗: 16 weeks, 6 month follow-up
次要结局
- 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)
研究者
Cenk Tek
Associate Professor
Yale University
研究点 (2)
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