Nutritional Status Assessment and Dietary Recommendations Program (VENREDI)

Effectiveness of a Nutritional Intervention in Improving the Mediterranean Diet in Older Adults

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).

Study Overview

• Status: Recruiting
• Conditions: Adherence to the Mediterranean Diet
• Intervention / Treatment: Other: VENREDI group; Other: Health education

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rosario Alonso Domínguez, PhD; Phone Number: 3280 0034923294500; Email: ralonsod@usal.es

Study Locations

• Spain
  • Salamanca, Spain, 37007
    • Recruiting
    • Rosario Alonso Domínguez
    • Contact: Rosario Alonso Domínguez, PhD; Phone Number: 3280 0034923294500; Email: ralonsod@usal.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; 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; Practical seminars aimed at improving the Mediterranean diet, guided by researchers.
Active Comparator: Control; Group educational talk, lasting 2 hours, aimed at correct compliance with the Mediterranean Diet according to current recommendations.	Other: Health education; Health education on Mediterranean diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to the Mediterranean Diet	Mediterranean Diet Adherence Questionnaire (MEDAS). Minimum [Worse] 0 - Maximum [Better] 14	Baseline, 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical activity	Short Physical Performance Battery. Minimum [Worse] 0 - Maximum [Better] 12	Baseline, 3 months
Sleep Quality	Atenas questionnaire. Minimum [Better] 0 - Maximum [Worse] 24	Baseline, 3 months
Cognitive function	MOCA questionnaire. Minimum [Worse] 0 - Maximum [Better] 30	Baseline, 3 months

Collaborators and Investigators

• Sponsor: University of Salamanca
• Collaborators: Ayuntamiento de Salamanca

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2023
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: April 3, 2024
• First Submitted That Met QC Criteria: April 10, 2024
• First Posted (Actual): April 12, 2024

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: AYTO_SALAMANCA_001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No