跳至主要内容
临床试验/NCT03119142
NCT03119142已完成不适用

Economic Crisis and Adherence to the Mediterranean Diet: Possible Impact on Biomarkers of Inflammation and Metabolic Phenotypes in the Cohort of the MOLI-SANI Study

Neuromed IRCCS1 个研究点 分布在 1 个国家目标入组 3,646 人开始时间: 2017年5月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
3,646
试验地点
1
主要终点
Adherence to the Mediterranean diet

研究概览

简要总结

The socioeconomic gradient in health is well known and is partially explained by differences in health-related behaviours across socioeconomic groups. There is reason to believe that the current economic crisis has been contributing to the observed rapid decrease in the adherence to the Mediterranean diet, thus reducing a protective factor against the development of major chronic diseases. This project aims at investigating whether the economic crisis could account for the shifting from the Mediterranean diet. Additionally, it will address variations in inflammation biomarkers (possibly dietary-related) or metabolic phenotypes as useful biological accounts for the decline in the adherence to Mediterranean diet. This project will also test whether for economically weakest people cultural resources could somehow attenuate the impact of material circumstances on lifestyle changes attributable to the economic crisis.

详细描述

Specific aims:

Aim 1: To identify population groups differently affected by the economic crisis within the population-based cohort of the MOLI-SANI study recruited in the years 2005-2006 (before economic crisis). This aim will be achieved by a new assessment of self-reported economic difficulties possibly emerged after the recruitment.

Aim 2: To estimate possible changes in dietary and health-related behaviours (with particular focus on the adherence to the Mediterranean diet) in subjects identified in the previous aim as highly or poorly affected by the economic crisis. Inflammatory status and metabolic phenotypes will be assessed in the two groups, recalled in a suitable proportion, to establish a possible link between shifting from the Mediterranean diet and adverse health outcomes. Quality of life and stress status will also be evaluated.

Aim 3: To evaluate in the group more affected by economic constraints whether nutrition knowledge and mass media exposure would account for the decline in the adherence to the Mediterranean diet and consequent changes in inflammatory status and/ or metabolic phenotypes.

Experimental Design Aim 1: Aim 1 will identify two groups of subjects as being most or less affected by the economic crisis. This aim will be reached by recall of 7,000 individuals from the Moli-sani cohort recruited in the years 2005-2006. Subjects will be administered a questionnaire to assess economic constraints likely occurred after the economic crisis onset. The questionnaire will update socioeconomic position and estimate economic constraints, food quality and food expenditure.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • The present study will include subjects recruited in the Moli-sani cohort during 2005-2006 and for which inclusion criteria were:
  • aged >=35 years
  • inscribed in the city hall registries

排除标准

  • The present study will include subjects recruited in the Moli-sani cohort during 2005-2006 and for which exclusion criteria were:
  • pregnancy at the time of recruitment,
  • disturbances in understanding or willingness
  • current poly-traumas or coma, refusal to sign the Informed Consent form

结局指标

主要结局

Adherence to the Mediterranean diet

时间窗: The follow-up is of 10 years since baseline enrolment (2005-2010)

Dietary information will be collected by administering the Italian version of the EPIC questionnaire (Pala V et al. Tumori. 2003;89:594-607), already used at baseline, to estimate the changes in dietary habits. Adherence to a Mediterranean dietary pattern will be evaluated both by a priori (Mediterranean Diet Score; Trichopoulou A et al. N Engl J Med. 2003;348:2599-608) and a posteriori approach (Principal Factor Analysis; Centritto F et al. Nutr Metab Cardiovasc Dis. 2009;19:697-706).

次要结局

  • Obesity(The follow-up is of 10 years since baseline enrolment (2005-2010))
  • Hypertension(The follow-up is of 10 years since baseline enrolment (2005-2010))
  • Hypercholesterolemia(The follow-up is of 10 years since baseline enrolment (2005-2010))
  • Inflammation(The follow-up is of 10 years since baseline enrolment (2005-2010))
  • Diabetes(The follow-up is of 10 years since baseline enrolment (2005-2010))

研究者

发起方
Neuromed IRCCS
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marialaura Bonaccio

PhD

Neuromed IRCCS

研究点 (1)

Loading locations...

相似试验

Economic Crisis and Adherence to the Mediterranean... | 临床试验