Universidad San Pablo-CEU
Alcorcón, Madrid, 28668, Spain
NCT Number: NCT07461883
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.
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Notify Me65 year and older
All sexes
Interventional
Not applicable
Alcorcón, Madrid, 28668, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants in this group attend monthly workshops on nutrition and healthy lifestyle habits during one year
Participants in this group receive level 0 intervention plus personalized dietary and lifestyle advice by a trained nutritionist.
Participants in this group receive level 1 intervention plus access to a purpose-designed mobile app for data visualization and reminders of personalized advice
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).
Time frame: From enrollment to the end of the intervention at 12 months
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.
Time frame: From enrollment to the end of the intervention at 12 months
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).
CEU San Pablo University
Other
Acronym: MyFOODSenior
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