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Completed

NCT Number: NCT07461883

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

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.

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Key information

Conditions

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad San Pablo-CEU

Alcorcón, Madrid, 28668, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

L0: non personalized dietary and lifestyle advice

Behavioral

Participants in this group attend monthly workshops on nutrition and healthy lifestyle habits during one year

L1: personalized dietary and lifestyle advice

Behavioral

Participants in this group receive level 0 intervention plus personalized dietary and lifestyle advice by a trained nutritionist.

L2: personalized dietary and lifestyle advice and digitalization

Behavioral

Participants in this group receive level 1 intervention plus access to a purpose-designed mobile app for data visualization and reminders of personalized advice

Primary outcomes

  1. Food literacy score assessed with the Food Literacy Questionnaire for Spanish older adults (FLQ-e)

    Time frame: From enrollment to the end of the intervention after 12 months

    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).

Secondary outcomes

  1. Dietary intake assessed by 3-day dietary record and nutrient analysis using DIAL software

    Time frame: From enrollment to the end of the intervention at 12 months

    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.

  2. Physical activity level assessed with the International Physical Activity Questionnaire - Short Version (IPAQ-sv)

    Time frame: From enrollment to the end of the intervention at 12 months

    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).

Sponsors and collaborators

Lead sponsor

CEU San Pablo University

Other

Collaborators

  • Departament of Electronic Technology, University of Seville, Seville, Spain
  • Fuenlabrada City Council (Ayuntamiento de Fuenlabrada, Spain)

Registry information

Acronym: MyFOODSenior

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 10, 2026
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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