The Lifestyle Intervention on 10-year Year Risk of Cardiovascular Disease Among Women in the Form of Cochrane Abstracts: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- Ten-year Risk of Cardiovascular Disease (CVD)
研究概览
简要总结
Patient education in lifestyle changes has a positive effect on health in individuals with cardiovascular (CV) risk. Despite current positive evidence about lifestyle and dietary change in the prevention of CVD, the recommendations are still not consistently and optimally applied to women.
The aim of the study was to analyze the effect of an intervention in the form of Cochrane abstract letters on women between 45 to 65 years.
详细描述
The study took place in family medicine (FM) offices from 1 February 2018 to 1 June 2020. Two FM offices were in the city of Split, the capital of the Split-Dalmatian County, two offices were in Osijek, the capital of the Osijek-Baranja County, one in Kutina, and one in Rijeka.
The participants were all women between 45 to 65 years. The investigators enrolled 210 participants, and the participants were divided in three groups. The first group was control group, and participants were not exposed to the intervention. The second group was passive-intervention group, which means the participants received letters in the same time period as active-intervention group but only with a reminder at their own cardiovascular disease risk. The third group was active-intervention group, where the participants received letters every three months, with their own cardiovascular disease risk and Cochrane abstracts in the form of blog-shots.
The study participants first completed the Pre-study questionnaire (Questionnaire 1), which included: a) demographic data, b) attitudes and knowledge questionnaire about CV risk factors, c) decisional conflict scale (DCS), and d) integrative hope scale (IHS).
Attitudes and knowledge questionnaire about CV risk factors was created according to the model of "Ottawa Decision Support Tutorial".
The DCS consist of 16 items rated in a 5-point Likert-type response format, and measures individual's uncertainty toward a course of action. There are five subscales: uncertainty, informed, values clarity, support and effective decision. The scores on the total scale and subscales are calculated as a sum of items, divided by the number of items and multiplied by 25, allowing for a score range from zero (no decisional conflict) to 100 points (extreme decisional conflict). The Croatian version of the scale was previously validated.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •female sex;
- •age 45 to 65 years, with one or more CV risk factors [overweight or obesity, i. e. body mass index (BMI) ≥25 kg/m2, and/or central obesity - waist circumference ≥88 cm, high blood pressure (systolic blood pressure ≥140 mm Hg and/or diastolic blood pressure ≥90 mm Hg), high blood cholesterol (≥5.2 mmol/L) and active smoking];
- •the participants on antihypertensive therapy were also included in the study.
排除标准
- •current cardiovascular disease (ischemic heart disease, peripheral artery disease, and stroke) were excluded;
- •the participants with malignant diseases;
- •the participants with serious systemic disease;
- •the participants with mental disease.
结局指标
主要结局
Ten-year Risk of Cardiovascular Disease (CVD)
时间窗: Change from baseline 10-year risk of CVD at 6 months
Ten-year risk of fatal CVD was estimated using the ACC/AHA (American College of Cardiology/American Heart Association) guidelines, based on the following data collected from the study participants: age, gender, race, total and HDL (high-density lipoprotein) cholesterol, systolic blood pressure, data about antihypertensive therapy, diabetes mellitus and smoking status.
次要结局
- Weight(Change from baseline weight at 6 months)
- Smoking Status(Change from baseline smoking status at 6 months)
- Body Mass Index (BMI)(Change from baseline BMI at 6 months)
- Waist Circumference(Change from baseline waist circumference at 6 months)
- Hips Circumference(Change from baseline hips circumference at 6 months)