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Clinical Trials/NCT07461883
NCT07461883
Completed
Not Applicable

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

CEU San Pablo University1 site in 1 country120 target enrollmentStarted: February 8, 2024Last updated:

Overview

Phase
Not Applicable
Status
Completed
Sponsor
CEU San Pablo University
Enrollment
120
Locations
1
Primary Endpoint
Food literacy score assessed with the Food Literacy Questionnaire for Spanish older adults (FLQ-e)

Overview

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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
65 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Level 0 (Control group, L0)

Active Comparator

Intervention: L0: non personalized dietary and lifestyle advice (Behavioral)

Level 1 (L1). Personalized Nutrition Group

Experimental

Intervention: L1: personalized dietary and lifestyle advice (Behavioral)

Level 2 (L2). Personalized and digitalized group

Experimental

Intervention: L2: personalized dietary and lifestyle advice and digitalization (Behavioral)

Outcomes

Primary Outcomes

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

  • 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)

Investigators

Sponsor
CEU San Pablo University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Rocio de la Iglesia

Professor, PhD, nutritionist

CEU San Pablo University

Study Sites (1)

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