Educational Strategy in Populations of Different Socioeconomic Status to Improve Cardiovascular Health Through a Digital Health Literacy Program: e-DUCASS Advance
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Mean Change From Baseline in Life's Essential 8 Score at 24 Months
研究概览
简要总结
The e-DUCASS Advance study is a randomized study evaluating whether a 24-month digital health education program can improve cardiovascular health among people living in Córdoba, Spain, and representing different socioeconomic backgrounds and areas of the city. Approximately 600 participants aged 12 to 79 years will be enrolled. Participants will be assigned by family so that members of the same family remain in the same study group.
All participants will first receive an initial basic health education workshop covering healthy eating, physical activity, sleep, tobacco use, and other health-related behaviors. Families will then be randomly assigned to one of two groups. The control group will receive no additional educational intervention, whereas the digital intervention group will receive weekly educational content through a web-based application or messaging channels. This content will include short videos, infographics, knowledge assessments, motivational activities, and access to support.
Cardiovascular health will be assessed at baseline, 12 months, and 24 months using the American Heart Association's Life's Essential 8 score. This score evaluates diet, physical activity, nicotine exposure, sleep, body mass index, blood lipids, blood glucose, and blood pressure.
The study will compare changes in cardiovascular health between the two groups and examine whether the effect of the program differs according to the socioeconomic characteristics of the participants' areas of residence. Other assessments will include adherence to a Mediterranean lifestyle, health and nutrition literacy, physical activity and sedentary behavior, chronotype, quality of life, anxiety, and depression.
详细描述
e-DUCASS Advance is a 24-month, parallel-group, cluster-randomized controlled trial designed to evaluate the effectiveness of an enhanced digital health literacy intervention for improving cardiovascular health among people with different socioeconomic backgrounds in Córdoba, Spain. Participants are recruited from across the city.
The household is the unit of randomization, ensuring that all participating members of the same household are assigned to the same trial arm and reducing the risk of contamination between groups. Households are randomized in a 1:1 ratio to the control or digital intervention group using stratified permuted block randomization.
Randomization is stratified by socioeconomic status and household composition, resulting in six strata. Household composition is classified into three categories: households with children, households comprising two or more adults without children, and single-person households. Socioeconomic status is categorized as high or low-middle. Households within the upper income quintile of the municipal distribution for Córdoba, based on the 2023 Household Income Distribution Atlas of the Spanish National Statistics Institute, are classified as high income. All remaining households are classified within the low-middle-income category.
The randomization sequence was generated by an independent statistical programmer using the blockrand package, version 1.5, in R statistical software, version 4.4.2. Allocation was centralized, and researchers responsible for participant recruitment were unaware of the block sizes and upcoming assignments. Randomization was implemented in three successive waves as recruitment progressed, following a prespecified master randomization log.
After the baseline clinical and sociodemographic assessment, all participants receive an initial basic health education workshop addressing healthy eating, physical activity, sleep, tobacco use, and other cardiovascular health-related behaviors. Participants assigned to the control group receive no further structured educational intervention. Participants assigned to the digital intervention group receive weekly educational content through a web-based application or messaging channels for 24 months.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Participants and the staff responsible for delivering the digital intervention and coordinating study visits were aware of treatment allocation. Access to allocation information was restricted to the nutritionist responsible for the intervention content and participant contact and the research nurse responsible for visit coordination and biological sample collection. Investigators responsible for outcome evaluation and the statistical analysts remained blinded to treatment allocation. Study data were coded so that group assignment was concealed during outcome assessment and statistical analysis.
入排标准
- 年龄范围
- 12 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 12 to 79 years.
- •Provision of written informed consent. For participants younger than 18 years, written informed consent from a parent or legal guardian and assent from the participant, when appropriate, are required.
- •Both healthy individuals and individuals with stable medical conditions are eligible. No specific disease or cardiovascular risk factor is required for participation.
排除标准
- •Life expectancy of less than 5 years.
- •Inability to complete the study intervention or scheduled study procedures, either independently or, when applicable, with support from a parent, legal guardian, or household member.
- •Serious or unstable medical conditions that could limit participation, follow-up, or survival, including hypertension or diabetes with target-organ damage affecting survival, disabling clinical manifestations of cerebrovascular disease, severe psychiatric illness, advanced chronic kidney disease, chronic liver disease, cancer under active treatment, severe or very severe chronic obstructive pulmonary disease, endocrine disease at risk of decompensation, or clinically significant chronic gastrointestinal disease.
研究组 & 干预措施
Control group
No further intervention
Digital Intervention Group
Participants receive the initial basic health education workshop provided to all study participants, followed by a 24-month enhanced digital health literacy intervention. Weekly educational content is delivered through a web-based application or messaging channels and includes short videos, infographics, brief knowledge assessments, motivational activities, participation feedback, and access to support. The content addresses healthy eating, physical activity, sleep, tobacco use, and other health-related behaviors aimed at improving cardiovascular health.
干预措施: Enhanced Digital Health Literacy Program (Behavioral)
结局指标
主要结局
Mean Change From Baseline in Life's Essential 8 Score at 24 Months
时间窗: Baseline and 24 months
Cardiovascular health will be assessed using the American Heart Association's Life's Essential 8 score. The overall score is calculated as the mean of eight component scores: diet, physical activity, nicotine exposure, sleep health, body mass index, blood lipids, blood glucose, and blood pressure. Each component and the overall score range from 0 to 100 points, with higher scores indicating better cardiovascular health.
次要结局
- Mean Change From Baseline in Life's Essential 8 Score at 12 Months(Baseline and 12 months)
- Mean Change From Baseline in Mediterranean Lifestyle Index Score at 24 Months(Baseline and 24 months)
- Mean Change From Baseline in Mediterranean Diet Adherence Screener Score at 24 Months(Baseline and 24 months)
- Mean Change From Baseline in Physical Activity at 24 Months(Baseline and 24 months)
- Mean Change From Baseline in Patient Health Questionnaire-9 Score at 24 Months(Baseline and 24 months)
- Mean Change From Baseline in Generalized Anxiety Disorder-7 Score at 24 Months(Baseline and 24 months)
- Mean Change From Baseline in EQ-5D-5L Index Score at 24 Months(Baseline and 24 months)