Nutritional Status Assessment and Dietary Recommendations Program (VENREDI)

NCT06361550 | Recruiting

• 1 other identifier: AYTO_SALAMANCA_001
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: The Mediterranean diet has been related to beneficial effects in the prevention of cardiovascular diseases and other chronic pathologies related to diet, including some types of cancer. Specifically in the elderly population, it has been observed that the Mediterranean diet is inversely associated with all causes of mortality and that the greater the adherence to this type of diet, the lower the mortality in elderly adults. Objective: To evaluate the effect of a multifactorial intervention (seminar on shopping basket and food labeling, workshop on healthy cooking and subsequent tasting of the prepared products) in improving adherence to the Mediterranean diet in older adults. Methodology: Randomized controlled clinical trial with two parallel groups: an intervention group (IG) and a control group (CG). The study population will be adults over 60 years of age, retired or pre-retired. A sample size of 200 participants has been estimated, 100 in each group to detect a difference of 0.83 points or more in the MEDAS questionnaire. All participants will receive an educational talk on healthy nutrition, with an estimated duration of 2 hours. The GI, in addition to this educational workshop, will receive a practical seminar on how to properly carry out the shopping cart. This will take place both in a market and later in a supermarket in Salamanca. In addition, a workshop will be held where participants will prepare a menu consisting of three dishes (starter, main and dessert) and will later taste them. An initial and post-intervention evaluation will be carried out after 3 months so that both groups can study the change variables related to Adherence to the Mediterranean Diet \[Mediterranean Diet Adherence Questionnaire (MEDAS)\], physical activity \[Short physical performance battery (SPPB)\], sleep quality (ATENAS questionnaire) and assessment of cognitive function (MOCA questionnaire).

Conditions

Adherence to the Mediterranean Diet

Outcome Measures

Primary Outcomes (1)

• Adherence to the Mediterranean Diet

  Mediterranean Diet Adherence Questionnaire (MEDAS). Minimum \[Worse\] 0 - Maximum \[Better\] 14

  Baseline, 3 months

Secondary Outcomes (3)

• Physical activity

  Baseline, 3 months

• Sleep Quality

  Baseline, 3 months

• Cognitive function

  Baseline, 3 months

Study Arms (2)

Intervention group

EXPERIMENTAL

Practical seminar, carried out in a market, on how to properly carry out the shopping cart. Afterwards, the participants will prepare a menu, consisting of three courses (starter, main and dessert). Finally, the tasting of the different preparations will take place.

Other: VENREDI group

Control

ACTIVE COMPARATOR

Group educational talk, lasting 2 hours, aimed at correct compliance with the Mediterranean Diet according to current recommendations.

Other: Health education

Interventions

VENREDI group OTHER

Practical seminars aimed at improving the Mediterranean diet, guided by researchers.

Intervention group

Health education OTHER

Health education on Mediterranean diet

Control

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be 60 years old, retired or in early retirement
• Participate in the program "Research in active aging with preventive physiotherapy - PReGe"
• Agree to participate in the study and sign the informed consent.

You may not qualify if:

• Present any pathology that prevents carrying out the workshops appropriately.

Sponsors & Collaborators

• University of Salamanca: lead
• Ayuntamiento de Salamanca: collaborator

Study Sites (1)

Rosario Alonso Domínguez

Salamanca, Salamanca, 37007, Spain

RECRUITING

Central Study Contacts

Rosario Alonso Domínguez, PhD

CONTACT

0034923294500; ralonsod@usal.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigation

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: April 12, 2024
• Study Start: November 2, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)