NCT07461883

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 8, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 9, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 9, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 10, 2026

Completed
Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

1.2 years

First QC Date

March 4, 2026

Last Update Submit

March 9, 2026

Conditions

Keywords

Personalized nutritionnutrigeneticsnutritional educationelderlyquality of lifeeHealth

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

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

    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)

    From enrollment to the end of the intervention at 12 months

Study Arms (3)

Level 0 (Control group, L0)

ACTIVE COMPARATOR
Behavioral: L0: non personalized dietary and lifestyle advice

Level 1 (L1). Personalized Nutrition Group

EXPERIMENTAL
Behavioral: L1: personalized dietary and lifestyle advice

Level 2 (L2). Personalized and digitalized group

EXPERIMENTAL
Behavioral: L2: personalized dietary and lifestyle advice and digitalization

Interventions

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

Level 1 (L1). Personalized Nutrition Group

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

Level 0 (Control group, L0)

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

Level 2 (L2). Personalized and digitalized group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad San Pablo-CEU

Alcorcón, Madrid, 28668, Spain

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, PhD, nutritionist

Study Record Dates

First Submitted

March 4, 2026

First Posted

March 10, 2026

Study Start

February 8, 2024

Primary Completion

April 9, 2025

Study Completion

April 9, 2025

Last Updated

March 10, 2026

Record last verified: 2026-03

Locations