Development and Validation of a Multimodal Intervention Program for Patients With Metabolic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 2
- 主要终点
- Waist circumference
研究概览
简要总结
The aim of this study is to identify the psychological, emotional and lifestyle variables that can have an influence on the different components of metabolic syndrome (MetS) and develop a program for change lifestyle in this patients.
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 (Participant)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 25 and 65 years age
- •Waist circumference >88 cm for women and >102 cm for men
- •Blood pressure: systolic ≥ 130 mmHg and diastolic ≥ 85 mmHg
- •Fasting glucose level ≥ 110mg/dL
- •Triglycerides: ≥ 150 mg/dL
- •HDL cholesterol ≤40 mg/dL in men and ≤50 mg/DL in women
排除标准
- •Osteoarthritis,
- •Active inflammatory diseases,
- •Severe psychiatric disorders and/or significant cognitive impairment assessed using the Mini-Mental State Examination.
结局指标
主要结局
Waist circumference
时间窗: 2 minutes
(cm). Measured using a tape measure placed in a horizontal plane, located at the midpoint between the last rib and the iliac crest
Blood pressure
时间窗: 15 minutes
Taken according to the recommendations of the American Heart Association, and considering the mean of three readings, each separated by two minutes.
Weight
时间窗: 2 minutes
weight (Kg)
Lipid profile
时间窗: 3 minutes
lipid profile (HDL-C, total cholesterol, triglycerides)
Glycemic profile (fasting glucose)
时间窗: 3 minutes
glycemic profile (fasting glucose)
次要结局
- Assertiveness Inventory(5 minutes)
- Fagerström Test for Nicotine Dependence(5 minutes)
- Perceived Stress Scale -PSS(5 minutes)
- Medical Outcomes Study 12-Item Short Form - SF-12(5 minutes)
- State-Trait Anger Expression Inventory-2 - STAXI-2(5 minutes)
- Mediterranean-diet scale(5 minutes)
研究者
Jaqueline Garcia da Silva
Ph.D. Student
Universidad de Granada