Clinical trial NCT06361550: Nutritional Status Assessment and Dietary Recommendations Program (VENREDI)
Official title: Effectiveness of a Nutritional Intervention in Improving the Mediterranean Diet in Older Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Adherence to the Mediterranean Diet
Lead sponsor: University of Salamanca
Sponsor class: OTHER
Collaborators: name: Ayuntamiento de Salamanca
First posted: 2024-04-12
Enrollment: 200
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Adherence to the Mediterranean Diet
timeFrame: Baseline, 3 months
Secondary outcomes:
measure: Physical activity
timeFrame: Baseline, 3 months
measure: Sleep Quality
timeFrame: Baseline, 3 months
measure: Cognitive function
timeFrame: Baseline, 3 months
Other outcomes:
Locations:
city: Salamanca
country: Spain
facility: Rosario Alonso Domínguez
Study officials:
References: