Nutritional Status Assessment and Dietary Recommendations Program (VENREDI)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorUniversity of Salamanca

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Present any pathology that prevents carrying out the workshops appropriately.

Trial design

Design model

Parallel

Treatments tested in this trial

  • VENREDI group

    Other intervention

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

  • Health education

    Other intervention

    Health education on Mediterranean diet

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Adherence to the Mediterranean Diet

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

Time frame
Baseline, 3 months

Secondary outcomes

1

Physical activity

Short Physical Performance Battery. Minimum \[Worse\] 0 - Maximum \[Better\] 12

Time frame
Baseline, 3 months
2

Sleep Quality

Atenas questionnaire. Minimum \[Better\] 0 - Maximum \[Worse\] 24

Time frame
Baseline, 3 months
3

Cognitive function

MOCA questionnaire. Minimum \[Worse\] 0 - Maximum \[Better\] 30

Time frame
Baseline, 3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Salamanca

Lead sponsor

Ayuntamiento de Salamanca

Collaborator