Food LiteracyMyFOODSeniorNCT07461883
Improving Food Literacy in the Elderly Through an eHealth Education Program Based on Personalized Nutrition
A study testing L0: non personalized dietary and lifestyle advice, L1: personalized dietary and lifestyle advice and L2: personalized dietary and lifestyle advice and digitalization in people with Food Literacy, run by CEU San Pablo University at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Food Literacy
- What is being tested?
- L0: non personalized dietary and lifestyle advice, L1: personalized dietary and lifestyle advice and L2: personalized dietary and lifestyle advice and digitalization
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 8 Feb 2024to 9 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 65 years and over
- Non-institutionalized
- Retired from main professional activity or part-time working
- Smartphone user.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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:
- 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
- Food Literacy
- Being tested
- L0: non personalized dietary and lifestyle advice, L1: personalized dietary and lifestyle advice, L2: personalized dietary and lifestyle advice and digitalization
- Keywords
- Personalized nutrition, nutrigenetics, nutritional education, elderly, quality of life, eHealth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L0: non personalized dietary and lifestyle adviceBehavioural
Participants in this group attend monthly workshops on nutrition and healthy lifestyle habits during one year
L1: personalized dietary and lifestyle adviceBehavioural
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 digitalizationBehavioural
Participants in this group receive level 1 intervention plus access to a purpose-designed mobile app for data visualization and reminders of personalized advice
| Study group | Role | What they receive |
|---|---|---|
| Level 0 (Control group, L0) | Active comparator | Not described Receives: Behavioral: L0: non personalized dietary and lifestyle advice |
| Level 1 (L1). Personalized Nutrition Group | Experimental | Not described Receives: Behavioral: L1: personalized dietary and lifestyle advice |
| Level 2 (L2). Personalized and digitalized group | Experimental | Not described Receives: Behavioral: L2: personalized dietary and lifestyle advice and digitalization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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.
Measured: 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)
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).
Measured: From enrollment to the end of the intervention at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start8 Feb 2024
- Primary completion9 Apr 2025
- Study completion9 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Food LiteracyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- CEU San Pablo University
- Sponsor type
- University, hospital or other
- Collaborators
- Fuenlabrada City Council (Ayuntamiento de Fuenlabrada, Spain), Departament of Electronic Technology, University of Seville, Seville, Spain
- Responsible party
- Principal investigator, Rocio de la Iglesia, CEU San Pablo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07461883
- Sponsor's protocol ID
- PID2021-124170OA-I00
- Other IDs
- PID2021-124170OA-I00
- Acronym
- MyFOODSenior
- Status last verified
- Mar 2026
- First submitted
- 4 Mar 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Alvarez-Martin C, Benavent M, Ubeda N, Garcia-Gonzalez A, Martinez-Saez N, Gonzalez MP, Achon M, Fajardo V, de la Iglesia R, Alonso-Aperte E. A multi-domain algorithm towards precision nutrition: integrating genetic risk scores and phenotypic diversity in the elderly, the MyFOOD4Senior study. Genes Nutr. 2026 Sep 22;21(1):23. doi: 10.1186/s12263-026-00822-y.
PubMed 42839264
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Food Literacy in the Elderly Through an eHealth Education Program Based on Personalized Nutrition
- ClinicalTrials.gov ID
- NCT07461883
- Acronym / sponsor ID
- MyFOODSenior / PID2021-124170OA-I00
- Conditions
- Food Literacy
- Keywords
- Personalized nutrition, nutrigenetics, nutritional education, elderly, quality of life, eHealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- CEU San Pablo UniversityUniversity, hospital or other
- Collaborators
- Fuenlabrada City Council (Ayuntamiento de Fuenlabrada, Spain), Departament of Electronic Technology, University of Seville, Seville, Spain
- Study start
- 8 Feb 2024 (actual)
- Primary completion
- 9 Apr 2025 (actual)
- Study completion
- 9 Apr 2025 (actual)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age 65 years and over
- Non-institutionalized
- Retired from main professional activity or part-time working
- Smartphone user.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L0: non personalized dietary and lifestyle adviceParticipants in this group attend monthly workshops on nutrition and healthy lifestyle habits during one year | Behavioural | Level 0 (Control group, L0) |
| L1: personalized dietary and lifestyle adviceParticipants in this group receive level 0 intervention plus personalized dietary and lifestyle advice by a trained nutritionist. | Behavioural | Level 1 (L1). Personalized Nutrition Group |
| L2: 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 | Behavioural | Level 2 (L2). Personalized and digitalized group |
Primary outcome
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).
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Derived from this study: PubMed 42839264Alvarez-Martin C, Benavent M, Ubeda N, Garcia-Gonzalez A, Martinez-Saez N, Gonzalez MP, Achon M, Fajardo V, de la Iglesia R, Alonso-Aperte E. A multi-domain algorithm towards precision nutrition: integrating genetic risk scores and phenotypic diversity in the elderly, the MyFOOD4Senior study. Genes Nutr. 2026 Sep 22;21(1):23. doi: 10.1186/s12263-026-00822-y.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L0: non personalized dietary and lifestyle advice, L1: personalized dietary and lifestyle advice and L2: personalized dietary and lifestyle advice and digitalization in people with Food Literacy, run by CEU San Pablo University at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07461883, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.