Effectiveness of an App for Mobile Phones (e-12HR) to Increase Adherence to Mediterranean Diet in University Students

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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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

Conditions
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Mediterranean Diet, Diet Habits, Healthy Eating Index

Intervention / Treatment
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* Behavioral: e-12HR app


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Both genders. Over the age of 18. 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. Exclusion Criteria: - Chronic pathologies, food intolerances or pregnancy (situations that could require specialized dietary recommendations).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants (university students) are included by probability single-stage cluster sampling at the Faculties of Medicine and Pharmacy at the University of Seville (Spain), selecting 4 random classrooms in each school. Of the 4 selected classrooms in each faculty (Medicine and Pharmacy), 2 are randomly assigned to the control group and 2 to the intervention group.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>This arm uses the 'non-feedback' e-12HR. This version of the application allows to calculate the Mediterranean Diet Serving Score (MDSS) index. | |
| Experimental: Intervention group<br>This arm uses the 'feedback' e-12HR. This version of the application allows to calculate the Mediterranean Diet Serving Score (MDSS) index; additionally, this version is designed to promote the Mediterranean diet. | Behavioral: e-12HR app<br>* The 'feedback' e-12HR version: This version of the application allows to calculate the Mediterranean Diet Serving Score (MDSS) index; additionally, this version is designed to promote the Mediterranean diet with two specific automatic functions: Evaluation of the user's MDSS index. Identification of the food groups for which the user has not fulfilled the Mediterranean diet recommendations (in addition, this version also provided the user the consumption recommendations established for these food groups).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the total score of the Mediterranean Diet Serving Score (MDSS) index at fourteen days of monitoring 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. | 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. | 
| Change in the total score of the Mediterranean Diet Serving Score (MDSS) index at twenty-one days of monitoring 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. | 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. | 
| Change in the total score of the Mediterranean Diet Serving Score (MDSS) index at twenty-eight days of monitoring 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. | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mediterranean Diet, Diet Habits, Healthy Eating Index