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临床试验/NCT06361550
NCT06361550招募中不适用

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

University of Salamanca2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年11月2日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
2
主要终点
Adherence to the Mediterranean Diet

研究概览

简要总结

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

Adherence to the Mediterranean Diet

时间窗: Baseline, 3 months

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

次要结局

  • Sleep Quality(Baseline, 3 months)
  • Cognitive function(Baseline, 3 months)
  • Physical activity(Baseline, 3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Fausto Jose Barbero-Iglesias

Principal investigation

University of Salamanca

研究点 (2)

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