Impact of a Physical Health Promotion Program for People With Serious Mental Illness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Decrease of at least 3 of the 5 criteria of metabolic syndrome
研究概览
简要总结
The aim of this study is to evaluate the effectiveness of a lifestyle intervention, to reduce the risk of metabolic syndrome in patients with serious mental illness who receive treatment with antipsychotic medications.
The hypothesis of the study is that: the application of a physical health promotion program in people with serious mental illness, who receive treatment with antipsychotic medications, carried out by a mental health nurse, will decrease the presence of metabolic syndrome and contribute to improve their quality of life.
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
- Single (Care Provider)
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
- •Diagnostic of serious mental illness.
- •Treatment with antipsychotics.
- •Met at least 3 of the 5 criteria of metabolic syndrome According to the NCEP ATP III definition.
排除标准
- •Medical contraindications to exercise
- •Admitted to hospital.
- •intellectual disability
研究组 & 干预措施
Experimental Group
This group will carry out the lifestyle intervention (Physical health promotion program) during 6 months.
The group will attend a session per week.
干预措施: Physical health promotion program (Behavioral)
Control group
usual care
结局指标
主要结局
Decrease of at least 3 of the 5 criteria of metabolic syndrome
时间窗: 6 months
Fasting glucose ≥110 mg/dL (or receiving drug therapy for hyperglycemia) Blood pressure ≥130/85 mm Hg (or receiving drug therapy for hypertension) Triglycerides ≥150 mg/dL (or receiving drug therapy for hypertriglyceridemia) HDL-C \<40 mg/dL in men or \<50 mg/dL in women (or receiving drug therapy for reduced HDL-C) Waist circumference ≥102 cm in men or ≥88 cm in women
次要结局
- Metabolic syndrome prevalence(6 months)
- Quality of life improvement(6 months)
- use of antipsychotic(6 months)
- Toxic habits(6 months)