Improving Food Literacy in the Elderly Through an eHealth Education Program Based on Personalized Nutrition (MyFOODSenior)

This controlled trial aims to assess the impact of personalization and digitalization on the development of skills related to food agency, safe dietary habits, and healthy lifestyles in a cohort of 120 free-living individuals aged 65 years and older. Participants are assigned to intervention and control groups to evaluate the effectiveness of tailored interventions leveraging personalized and digital approaches.

Study Overview

• Status: Completed
• Conditions: Food Literacy
• Intervention / Treatment: Behavioral: L0: non personalized dietary and lifestyle advice; Behavioral: L1: personalized dietary and lifestyle advice; Behavioral: L2: personalized dietary and lifestyle advice and digitalization

Detailed Description

The "proof of principle" study was a one-year, three-arm controlled trial conducted in free-living men and women over 65 years old living in Madrid, Spain. The study aimed to answer the following questions:

i) Did personalization of dietary and lifestyle advice improve diet and food literacy, promoting healthy lifestyles? ii) Was the use of a specifically designed mobile app effective in assisting and/or motivating study participants to make and sustain appropriate health-promoting changes? To answer these questions, participants were assigned to a Control group (Level 0) or to one of two intervention groups for a one-year period.

Participants were recruited in Cultural associations in Fuenlabrada, a town in southern Madrid. A cluster sampling was carried out, randomly selecting three centers from among the eight Cultural Centers for the Elderly existing in Fuenlabrada. One center acted as a control center, while the other two provided the sample of seniors who were the subjects of the interventions (one center for L1 (personalization) and another for L2 (personalization and digitalization)). Adequate distance between the selected centers was ensured to avoid cross-contamination between participants. Participation in the project was offered to all users of the selected centers who met the inclusion criteria, up to the number of participants required for the project.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Alcorcón, Madrid, Spain, 28668
      • Universidad San Pablo-CEU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 65 years and over
• Non-institutionalized
• Retired from main professional activity or part-time working
• Smartphone user.

Exclusion Criteria:

• Presence of a severe or limiting disease (such as cancer, dementia, advanced Parkinson's disease, or any other serious pathological condition)
• Use of a pacemaker or implantable automatic defibrillator
• Adherence to a specific prescribed diet for any reason other than a low-sodium, low-fat, or weight-control diet.
• Diagnosis of digestive disorders such as celiac disease or Crohn's disease, or any metabolic disease or condition that alters nutritional requirements.
• Use of enteral or parenteral nutritional support at home.
• Presence of cognitive or psychomotor impairment.
• Expectation of institutionalization.
• Consumption of more than five main meals per week outside the home

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Level 0 (Control group, L0)	Behavioral: L0: non personalized dietary and lifestyle advice; Participants in this group attend monthly workshops on nutrition and healthy lifestyle habits during one year
Experimental: Level 1 (L1). Personalized Nutrition Group	Behavioral: L1: personalized dietary and lifestyle advice; Participants in this group receive level 0 intervention plus personalized dietary and lifestyle advice by a trained nutritionist.
Experimental: Level 2 (L2). Personalized and digitalized group	Behavioral: L2: personalized dietary and lifestyle advice and digitalization; Participants in this group receive level 1 intervention plus access to a purpose-designed mobile app for data visualization and reminders of personalized advice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Food literacy score assessed with the Food Literacy Questionnaire for Spanish older adults (FLQ-e)	The Food Literacy Questionnaire for Spanish older adults (FLQ-e) consists of 41 items covering five domains of food literacy: (1) basic healthy eating, (2) label consultation and food selection, (3) meal planning and budgeting, (4) food safety, preparation and cooking, and (5) awareness of the influence of food on personal wellbeing. The questionnaire generates a total food literacy score ranging from 0 to 123 points. Based on this score, participants are classified into three levels of food literacy: low (0-41 points), medium (42-82 points), and high (83-123 points).	From enrollment to the end of the intervention after 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dietary intake assessed by 3-day dietary record and nutrient analysis using DIAL software	Dietary intake assessed using a 3-day dietary record. Reported foods analyzed using DIAL software to estimate daily energy and nutrient intake. Nutrient and food group intake are compared with dietary reference guidelines for older adults to evaluate adherence to dietary recommendations. Unit of measure: Daily energy intake (kcal/day) and nutrient intake (e.g., g/day or mg/day), and adherence to dietary recommendations.	From enrollment to the end of the intervention at 12 months
Physical activity level assessed with the International Physical Activity Questionnaire - Short Version (IPAQ-sv)	The IPAQ-sv provides estimates of time spent in different intensities of physical activity and total physical activity expressed as metabolic equivalent minutes per week (MET-minutes/week).	From enrollment to the end of the intervention at 12 months

Collaborators and Investigators

• Sponsor: CEU San Pablo University
• Collaborators: Fuenlabrada City Council (Ayuntamiento de Fuenlabrada, Spain); Departament of Electronic Technology, University of Seville, Seville, Spain

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2024
• Primary Completion (Actual): April 9, 2025
• Study Completion (Actual): April 9, 2025

Study Registration Dates

• First Submitted: March 4, 2026
• First Submitted That Met QC Criteria: March 9, 2026
• First Posted (Actual): March 10, 2026

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: quality of life; elderly; eHealth; nutrigenetics; Personalized nutrition; nutritional education
• Other Study ID Numbers: PID2021-124170OA-I00 (Other Grant/Funding Number: MCIN/AEI/10.13039/501100011033 ERDF A Way of Making Europe)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No