Effectiveness of a Personalized Intervention Program for the Promotion of the Mediterranean Diet, Based on a Mobile Phone Application (e12HR), in Students of the University of Seville
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 322
- 试验地点
- 2
- 主要终点
- Change in the total score of the Mediterranean Diet Serving Score (MDSS) index at fourteen days of monitoring in both arms.
研究概览
简要总结
This is a controlled, randomized and multicentric clinical trial aimed at university students and performed at the Faculties of Medicine and Pharmacy at the University of Seville (Spain). Its objective is to evaluate the effect of an intervention based on the use of an information and communication technology (ICT) tool, specifically an application for mobile telephones (called e-12HR), in the improvement of adherence to the Mediterranean diet.
详细描述
Objective:
To evaluate the effect of an intervention based on the use of an information and communication technology (ICT) tool, specifically an application for mobile telephones (called e-12HR), in the increased adherence to the Mediterranean diet in a population of university students.
Design and setting:
A controlled, randomized and multicentric clinical trial with two parallel groups (control group and intervention group).
Study population:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Due to the nature of the intervention, participants cannot be blinded. However, the person responsible for the statistical analysis remains blinded throughout the study. In addition, although the different versions of the application are available in the Apple Store or Play Store at all times, personal alphanumeric codes are assigned to the participants; so that each participant only has access to him/her version of the application depending on whether they belong to the intervention group ('feedback' e-12HR) or to the control group ('non-feedback' e-12HR).
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Both genders.
- •Over the age of
- •Be a student at the Faculties of Medicine or Pharmacy (University of Seville).
- •Possess a mobile telephone with Internet access and iOS or Android operating system.
排除标准
- •Chronic pathologies, food intolerances or pregnancy (situations that could require specialized dietary recommendations).
结局指标
主要结局
Change in the total score of the Mediterranean Diet Serving Score (MDSS) index at fourteen days of monitoring in both arms.
时间窗: To assess the effect of the intervention, the change in the total score of the Mediterranean Diet Serving Score (MDSS) index is calculated at fourteen days after the initial intervention in both arms.
Mediterranean Diet Serving Score (MDSS) index is a metric which provides an assessment of the degree to which individuals follow the Mediterranean diet. It took into account previously-established rules which consider: Specific food groups, recommendations for consumption frequency for standard servings (per meal, daily or weekly) and a numerical score assigned to each item.
Change in the total score of the Mediterranean Diet Serving Score (MDSS) index at twenty-one days of monitoring in both arms.
时间窗: To assess the effect of the intervention, the change in the total score of the Mediterranean Diet Serving Score (MDSS) index is calculated at twenty-one days after the initial intervention in both arms.
Mediterranean Diet Serving Score (MDSS) index is a metric which provides an assessment of the degree to which individuals follow the Mediterranean diet. It took into account previously-established rules which consider: Specific food groups, recommendations for consumption frequency for standard servings (per meal, daily or weekly) and a numerical score assigned to each item.
Change in the total score of the Mediterranean Diet Serving Score (MDSS) index at twenty-eight days of monitoring in both arms.
时间窗: To assess the effect of the intervention, the change in the total score of the Mediterranean Diet Serving Score (MDSS) index is calculated at twenty-eight days after the initial intervention in both arms.
Mediterranean Diet Serving Score (MDSS) index is a metric which provides an assessment of the degree to which individuals follow the Mediterranean diet. It took into account previously-established rules which consider: Specific food groups, recommendations for consumption frequency for standard servings (per meal, daily or weekly) and a numerical score assigned to each item.
次要结局
未报告次要终点
研究者
Luis María Béjar Prado
Lecturer (Department of Preventive Medicine and Public Health)
University of Seville