- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05532137
Effectiveness of an App for Mobile Phones (e-12HR) to Increase Adherence to Mediterranean Diet in University Students
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 Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Luis M Bejar, Doctor
- Phone Number: 34 600024248
- Email: lmbprado@us.es
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: 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.
|
|
Experimental: 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.
|
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:
|
What is the study measuring?
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.
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.
|
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.
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.
|
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.
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.
|
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.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Luis M Bejar, Doctor, Lecturer (Department of Preventive Medicine and Public Health)
Publications and helpful links
General 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2813-N-21
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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