Mediterranean DietNCT05532137
Effectiveness of an App for Mobile Phones (e-12HR) to Increase Adherence to Mediterranean Diet in University Students
A study testing e-12HR app in people with Mediterranean Diet and Diet Habits, run by Luis María Béjar Prado at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Mediterranean Diet, Diet Habits, Healthy Eating Index
- What is being tested?
- e-12HR app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 322 participants
- Where
- 1 siteSpain
- Study dates
- 4 Apr 2022to 16 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Chronic pathologies, food intolerances or pregnancy (situations that could require specialized dietary recommendations).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Department of Preventive Medicine and Public Health
Seville, 41009
Angel Vilches, Doctor, 34 954551771, ava@us.es
About this study
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.
Read the 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).
- Conditions
- Mediterranean Diet, Diet Habits, Healthy Eating Index
- Being tested
- e-12HR app
- Keywords
- Mediterranean Diet, Diet Habits, Healthy Eating Index
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
e-12HR appBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | This arm uses the 'non-feedback' e-12HR. This version of the application allows to calculate the Mediterranean Diet Serving Score (MDSS) index. |
| Intervention group | Experimental | 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. Receives: Behavioral: e-12HR app |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start4 Apr 2022
- Primary completion16 Dec 2024 (estimated)
- Study completion16 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Mediterranean DietStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 322 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luis María Béjar Prado
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Luis María Béjar Prado, University of Seville
- Investigators
- Luis M Bejar, Doctor, Principal investigator, Lecturer (Department of Preventive Medicine and Public Health)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05532137
- Sponsor's protocol ID
- 2813-N-21
- Status last verified
- Dec 2024
- First submitted
- 2 Sep 2022
- Last updated
- 24 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27806922Bejar 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.
PubMed 29095013Bejar 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.
PubMed 28789723Bejar 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.
PubMed 29907555Bejar 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.
PubMed 30973343Bejar 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.
PubMed 35889767Bejar 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.
PubMed 38190226
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05532137
- Acronym / sponsor ID
- 2813-N-21
- Conditions
- Mediterranean Diet, Diet Habits, Healthy Eating Index
- Keywords
- Mediterranean Diet, Diet Habits, Healthy Eating Index
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 322 participants (estimated)
- Lead sponsor
- Luis María Béjar PradoUniversity, hospital or other
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- 16 Dec 2024 (estimated)
- Study completion
- 16 Dec 2025 (estimated)
- First posted
- 8 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –This arm uses the 'non-feedback' e-12HR. This version of the application allows to calculate the Mediterranean Diet Serving Score (MDSS) index. |
| Intervention group | Experimental | Behavioral: e-12HR appThis 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Chronic pathologies, food intolerances or pregnancy (situations that could require specialized dietary recommendations).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| e-12HR appThe '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). | Behavioural | Intervention group |
Primary outcome
Change in the total score of the Mediterranean Diet Serving Score (MDSS) index at fourteen days of monitoring in both arms.
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.
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.
Change in the total score of the Mediterranean Diet Serving Score (MDSS) index at twenty-one days of monitoring in both arms.
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.
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.
Change in the total score of the Mediterranean Diet Serving Score (MDSS) index at twenty-eight days of monitoring in both arms.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
- Background: PubMed 27806922Bejar 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.
- Background: PubMed 29095013Bejar 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.
- Background: PubMed 28789723Bejar 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.
- Background: PubMed 29907555Bejar 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.
- Background: PubMed 30973343Bejar 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.
- Background: PubMed 35889767Bejar 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.
- Derived from this study: PubMed 38190226Bejar 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Luis M Bejar, Doctor principal investigator
Lecturer (Department of Preventive Medicine and Public Health)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing e-12HR app in people with Mediterranean Diet and Diet Habits, run by Luis María Béjar Prado at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luis M Bejar, Doctor (34 600024248, lmbprado@us.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the total score of the Mediterranean Diet Serving Score (MDSS) index at fourteen days of monitoring in both arms. (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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05532137, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2024.