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
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | L0: non personalized dietary and lifestyle advice | Participants in this group attend monthly workshops on nutrition and healthy lifestyle habits during one year |
| 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. |
| 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 |
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.