Clinical Trials Directory

Trials / Completed

CompletedNCT07461883

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
120 (actual)
Sponsor
CEU San Pablo University · Academic / Other
Sex
All
Age
65 Years
Healthy volunteers
Not accepted

Summary

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.

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALL0: non personalized dietary and lifestyle adviceParticipants in this group attend monthly workshops on nutrition and healthy lifestyle habits during one year
BEHAVIORALL1: personalized dietary and lifestyle adviceParticipants in this group receive level 0 intervention plus personalized dietary and lifestyle advice by a trained nutritionist.
BEHAVIORALL2: personalized dietary and lifestyle advice and digitalizationParticipants in this group receive level 1 intervention plus access to a purpose-designed mobile app for data visualization and reminders of personalized advice

Timeline

Start date
2024-02-08
Primary completion
2025-04-09
Completion
2025-04-09
First posted
2026-03-10
Last updated
2026-03-10

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT07461883. Inclusion in this directory is not an endorsement.