Clinical trial NCT05532137: Effectiveness of an App for Mobile Phones (e-12HR) to Increase Adherence to Mediterranean Diet in University Students
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mediterranean Diet
Diet Habits
Healthy Eating Index
Keywords: Mediterranean Diet
Diet Habits
Healthy Eating Index
Lead sponsor: University of Seville
Sponsor class: OTHER
First posted: 2022-09-08
Enrollment: 322
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

Brief summary: 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: 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).

Eligibility criteria: 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).

Primary outcomes:
measure: Change in the total score of the Mediterranean Diet Serving Score (MDSS) index at fourteen days of monitoring in both arms.
timeFrame: 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.
measure: Change in the total score of the Mediterranean Diet Serving Score (MDSS) index at twenty-one days of monitoring in both arms.
timeFrame: 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.
measure: Change in the total score of the Mediterranean Diet Serving Score (MDSS) index at twenty-eight days of monitoring in both arms.
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Seville
country: Spain
facility: Department of Preventive Medicine and Public Health
Study officials:
affiliation: Lecturer (Department of Preventive Medicine and Public Health)
name: Luis M Bejar, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bejar LM, Sharp BN, Garcia-Perea MD. The e-EPIDEMIOLOGY Mobile Phone App for Dietary Intake Assessment: Comparison with a Food Frequency Questionnaire. JMIR Res Protoc. 2016 Nov 2;5(4):e208. doi: 10.2196/resprot.5782.
citation: Bejar LM, Vazquez-Limon E. Is there any alternative to traditional food frequency questionnaire for evaluating habitual dietary intake? Nutr Hosp. 2017 Jul 28;34(4):990-888. doi: 10.20960/nh.650.
citation: Bejar LM. First evaluation steps of a new method for dietary intake estimation regarding a list of key food groups in adults and in different sociodemographic and health-related behaviour strata. Public Health Nutr. 2017 Oct;20(15):2660-2669. doi: 10.1017/S1368980017001641. Epub 2017 Aug 9.
citation: Bejar LM, Reyes OA, Garcia-Perea MD. Electronic 12-Hour Dietary Recall (e-12HR): Comparison of a Mobile Phone App for Dietary Intake Assessment With a Food Frequency Questionnaire and Four Dietary Records. JMIR Mhealth Uhealth. 2018 Jun 15;6(6):e10409. doi: 10.2196/10409.
citation: Bejar LM, Garcia-Perea MD, Reyes OA, Vazquez-Limon E. Relative Validity of a Method Based on a Smartphone App (Electronic 12-Hour Dietary Recall) to Estimate Habitual Dietary Intake in Adults. JMIR Mhealth Uhealth. 2019 Apr 11;7(4):e11531. doi: 10.2196/11531.
citation: Bejar LM. Weekend-Weekday Differences in Adherence to the Mediterranean Diet among Spanish University Students. Nutrients. 2022 Jul 8;14(14):2811. doi: 10.3390/nu14142811.