A Randomized Controlled Trial of Lifestyle Intervention for Cardiovascular Disease Risk Factors Among Female Residents at the National Guard Residential City, Jeddah, Saudi Arabia, 2015
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 主要终点
- Framingham Risk Scores Reduction
研究概览
简要总结
Cardiovascular disease (CVD) remains the major cause of mortality globally. Applying a comprehensive interventional program based on the individual's risk may reduce the incidence and complications of CVD; thus, helping to decrease the burden on the healthcare system. This study compared the effects of a 3-month intervention involving lifestyle modification and physical activity with standard care in women ≥30 years having a moderate-to-high risk of CVD, with respect to improving physical activity and cardiovascular disease risk factors at the National Guard Residential City in Jeddah, Saudi Arabia, in 2015. The effects of this community-based lifestyle program were assessed through a randomized controlled trial. Women in the intervention group (n=31) received health education, exercise training, and diet counselling as individuals and in groups according to the participant's risk. Women in the control group (n=28) received one health education session at the screening site. The Framingham risk score (FRS) was calculated at baseline and at 3 months for both groups. The mean participant age was 42±8 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged ≥ 30 years.
- •The participants must be at moderate to high-risk of CVD according to FRS.
排除标准
- •Women aged < 30 years.
- •Women aged ≥ 30 years with low risk of CVD according to FRS.
- •Pregnant women.
- •Female patients diagnosed with CVD.
结局指标
主要结局
Framingham Risk Scores Reduction
时间窗: 3 months
The proportion of individuals with moderate Framingham risk scores (FRS) reducing their risk by 10% and the proportion of individuals with high (FRS) reducing their risk by 25% using the Framingham risk score. It consists of six point scores including age, total cholesterol, smoking status, HDL level, diabetes status, systolic Blood Pressure and Treatment Status. The sum of these points will result in an estimate of the 10-Year risk of developing cardiovascular event and for risk categorization of low (\< 10% FRS), moderate (10%-19% FRS), or high risk (≥ 20% FRS).
次要结局
- Framingham Risk Category Changes(3 months)
研究者
Jumana Khouja
Assistant Consultant
King Abdullah International Medical Research Center