Effectiveness of an App for Mobile Phones (e-12HR) to Increase Adherence to Mediterranean Diet in University Students

NCT05532137 | Recruiting

• 1 other identifier: 2813-N-21
• Study Type: interventional
• Target: 322
• Locations: 1 country
• Sites: 1

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.

Conditions

Mediterranean Diet; Diet Habits; Healthy Eating Index

Keywords

Mediterranean Diet; Diet Habits; Healthy Eating Index

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  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.

Study Arms (2)

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.

Behavioral: e-12HR app

Interventions

e-12HR app BEHAVIORAL

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).

Intervention group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- Chronic pathologies, food intolerances or pregnancy (situations that could require specialized dietary recommendations).

Sponsors & Collaborators

• Luis María Béjar Prado: lead

Study Sites (1)

Department of Preventive Medicine and Public Health

Seville, 41009, Spain

RECRUITING

Related Publications (7)

• 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.

  PMID: 27806922 BACKGROUND

• 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.

  PMID: 29095013 BACKGROUND

• 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.

  PMID: 28789723 BACKGROUND

• 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.

  PMID: 29907555 BACKGROUND

• 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.

  PMID: 30973343 BACKGROUND

• 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.

  PMID: 35889767 BACKGROUND

• 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.

  PMID: 38190226 DERIVED

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Study Officials

• Luis M Bejar, Doctor

  Lecturer (Department of Preventive Medicine and Public Health)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luis M Bejar, Doctor

CONTACT

34 600024248; lmbprado@us.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the intervention, participants cannot be blinded. However, the person responsible for the statistical analysis remains blinded throughout the study. In addition, although the different versions of the application are available in the Apple Store or Play Store at all times, personal alphanumeric codes are assigned to the participants; so that each participant only has access to him/her version of the application depending on whether they belong to the intervention group ('feedback' e-12HR) or to the control group ('non-feedback' e-12HR).
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer (Department of Preventive Medicine and Public Health)

Model Details: 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.

Study Record Dates

• First Submitted: September 2, 2022
• First Posted: September 8, 2022
• Study Start: April 4, 2022
• Primary Completion: December 16, 2024
• Study Completion: December 16, 2025
• Last Updated: December 24, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)