Mediterranean Diet Clinical Trial
Official title:
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
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.
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: 322 university students (161 participants in each group) are necessary; of both genders, over the age of 18 years, who meet selection criteria. Study setting: Faculties of Medicine and Pharmacy at the University of Seville (Spain). Statistical Analysis Discrete variables are presented as a number followed by percentages. Continuous variables are presented using means and standard deviations. The data are tested for normality using the nonparametric Kolmogorov-Smirnov test. Students t-test or the nonparametric Mann-Whitney U-test is used for the analysis of quantitative variables, and the chi-square test is used for the comparison of proportions. The results are considered significant if p-value < 0.05. Statistical analyses are performed using the SPSS statistical software package ver-sion 26.0 (SPSS Inc., Chicago, Illinois, USA). Measurements and intervention: Adherence to the Mediterranean diet is evaluated at seven (baseline), fourteen, twenty-one and twenty-eight days follow-up: the adherence to the Mediterranean diet index selected for the study is the Mediterranean Diet Serving Score (MDSS) index. The advice on healthy diet recommendations (Mediterranean diet) is common to both groups. There are two versions of e-12HR in the study: 'feedback' e-12HR and 'non-feedback' e-12HR (both versions of the application allow the collection of data on dietary intake in order to calculate the MDSS index). Control group: use of 'non-feedback' e-12HR (in order to calculate the MDSS index). Intervention group: use of 'feedback' e-12HR (in order to calculate the MDSS index; additionally, this version is designed to promote the Mediterranean diet). ;
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