An interventional study of e-12HR app in Mediterranean Diet, Diet Habits and Healthy Eating Index, sponsored by Luis María Béjar Prado. Recruiting at 1 site in Spain. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-24.
Sponsored by Luis María Béjar Prado · Not applicable, Interventional, and Other
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).
985 studies on the registry are indexed under Feeding Behavior; 178 are open to participants now.
This study's planned enrollment of 322 is above the median of 77 across 700 interventional studies indexed under Feeding Behavior.
Browse Feeding Behavior studies →This is the only study on the registry with Luis María Béjar Prado as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
- Chronic pathologies, food intolerances or pregnancy (situations that could require specialized dietary recommendations).
This arm uses the 'non-feedback' e-12HR. This version of the application allows to calculate the Mediterranean Diet Serving Score (MDSS) index.
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
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: 1. Evaluation of the user's MDSS index. 2. 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).
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Plan to share: No
Started Apr 2022 (actual). Primary completion is estimated for Dec 2024, 32 months after the start.
Of 503 non-industry interventional studies with no phase under Feeding Behavior, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 31. This study's planned 32 months is above that.
Counting every sponsor, half of 515 studies reached it within 14 months; a quarter within 5 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
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