A Digital Lifestyle Intervention in Primary Healthcare to Prevent Cardiovascular Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 6
- 主要终点
- LDL-cholesterol
研究概览
简要总结
Unhealthy lifestyle behaviors are well-established risk factors for cardiovascular disease (CVD) which is the leading cause of death globally and in Sweden. Digitalization offers new and better possibilities for healthcare to fulfil their responsibility to support healthier lifestyles, however, to ensure scalability and sustained implementation of digital tools within healthcare, digital interventions need to be systematically maintained and delivered by the primary healthcare. The aim of this project is to evaluate whether a digital lifestyle intervention, developed within Swedish primary healthcare, can improve clinically important cardiovascular health outcomes and lifestyle behaviors. In this multi-center randomized controlled trial patients, 40-60 years, in Swedish primary healthcare will be recruited and randomized to the control or intervention group. All participants will receive standard care consisting of one structured health dialogue focused on lifestyle habits. The intervention group will also receive support through the digital lifestyle intervention for creating healthy habits regarding diet, physical activity, alcohol consumption, and tobacco usage. The primary outcome is LDL-cholesterol at 6 months post-randomization. Secondary outcomes 6 months post-randomization are HDL-, total cholesterol, fasting blood glucose, triglycerides, non-HDL, blood pressure, weight, height, BMI, waist circumference, cardiovascular risk evaluation (SCORE2), dietary intake, physical activity, sleep, stress, alcohol consumption, tobacco use, and health-related 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
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 39 Years 至 61 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Attended a Health dialogue visit to primary healthcare for patients 40-60 years old
- •Willing to change at least one lifestyle behavior regarding physical activity, diet, smoking/snus, alcohol, sleep, or stress
排除标准
- •heart failure
- •history of myocardial infarction
- •history of stroke
- •pregnancy
研究组 & 干预措施
Digital lifestyle intervention
Access to the digital intervention which will provide support for healthier lifestyle behaviors regarding diet, physical activity, sleep, stress, alcohol consumption, and use of tobacco.
干预措施: Digital lifestyle intervention (Behavioral)
Control arm
Standard care i.e., a routine appointment to the primary healthcare center for discussing lifestyle habits
结局指标
主要结局
LDL-cholesterol
时间窗: 6 months post-randomization
Low density lipoprotein cholesterol
次要结局
- Health-related quality of life(6 months post-randomization)
- Physical activity(6 months post-randomization)
- Weight(6 months post-randomization)
- Height(6 months post-randomization)
- Sedentary time(6 months post-randomization)
- Stress(6 months post-randomization)
- Sleep(6 months post-randomization)
- Body mass index(6 months post-randomization)
- Waist circumference(6 months post-randomization)
- HDL-cholesterol(6 months post-randomization)
- Total cholesterol(6 months post-randomization)
- Fasting blood glucose(6 months post-randomization)
- Triglycerides(6 months post-randomization)
- Non-HDL cholesterol(6 months post-randomization)
- Systolic blood pressure(6 months post-randomization)
- Diastolic blood pressure(6 months post-randomization)
- Diet intake(6 months post-randomization)
- Systematic COronary Risk Evaluation model, second version (SCORE2)(6 months post-randomization)
- Alcohol consumption(6 months post-randomization)
- Tobacco use(6 months post-randomization)
- Mediated effects on behavior change(6 months post-randomization)
- Participant experience from using the digital intervention(6 months post-randomization)
研究者
Marie Löf, docent
Professor
Karolinska Institutet