Effectiveness of an App for Mobile Phones (e-12HR) to Increase Adherence to Mediterranean Diet in University Students
NCT ID: NCT05532137
Last Updated: 2024-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
322 participants
INTERVENTIONAL
2022-04-04
2025-12-16
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
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.
OTHER
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control group
This arm uses the 'non-feedback' e-12HR. This version of the application allows to calculate the Mediterranean Diet Serving Score (MDSS) index.
No interventions assigned to this group
Intervention group
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.
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).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
18 Years
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Luis María Béjar Prado
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Luis María Béjar Prado
Lecturer (Department of Preventive Medicine and Public Health)
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Luis M Bejar, Doctor
Role: PRINCIPAL_INVESTIGATOR
Lecturer (Department of Preventive Medicine and Public Health)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Preventive Medicine and Public Health
Seville, , Spain
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Angel Vilches, Doctor
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
Bejar LM, Mesa-Rodriguez P, Garcia-Perea MD. Short-Term Effect of a Health Promotion Intervention Based on the Electronic 12-Hour Dietary Recall (e-12HR) Smartphone App on Adherence to the Mediterranean Diet Among Spanish Primary Care Professionals: Randomized Controlled Clinical Trial. JMIR Mhealth Uhealth. 2024 Jan 8;12:e49302. doi: 10.2196/49302.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2813-N-21
Identifier Type: -
Identifier Source: org_study_id