Economic Crisis and Adherence to the Mediterranean Diet (CASSIOPEA)

NCT03119142 | Completed

• 1 other identifier: 5/17
• Study Type: observational
• Target: 3,646
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dietary Habits; Inflammation; Economic Problems; Obesity; Diabetes; Hypertension

Outcome Measures

Primary Outcomes (1)

• Adherence to the Mediterranean diet

  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).

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

Secondary Outcomes (5)

• 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)

• Diabetes

  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)

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

MOLI-SANI is a population-based cohort study that recruited, between 2005 and 2010, 24,325 men and women at random from individuals aged 35 years or older resident in the Molise region, to investigate genetic and environmental risk factors for cardiovascular, cerebrovascular and tumour diseases. Of them, the present study will include about 7,000 subjects recruited in 2005-2006.

You may qualify if:

• aged \>=35 years
• inscribed in the city hall registries

You may not qualify if:

• pregnancy at the time of recruitment,
• disturbances in understanding or willingness
• current poly-traumas or coma, refusal to sign the Informed Consent form

Sponsors & Collaborators

• Neuromed IRCCS: lead

Study Sites (1)

Irccs Neuromed

Campobasso, 86100, Italy

Location

Related Publications (1)

• Bonaccio M, Costanzo S, Di Castelnuovo A, Persichillo M, De Curtis A, Olivieri M, Cerletti C, Donati MB, de Gaetano G, Iacoviello L; CASSIOPEA Study and Moli-sani Study Investigators. The CASSIOPEA Study (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): Rationale, design and characteristics of participants. Nutr Metab Cardiovasc Dis. 2021 Apr 9;31(4):1053-1062. doi: 10.1016/j.numecd.2020.12.008. Epub 2020 Dec 13.

  PMID: 33549444 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be obtained from participants who had fasted overnight and had refrained from smoking for at least 6 h and stored in liquid nitrogen in the Biological bank of the Moli-sani study.

MeSH Terms

Conditions

Feeding Behavior; Inflammation; Obesity; Diabetes Mellitus; Hypertension

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: April 10, 2017
• First Posted: April 18, 2017
• Study Start: May 2, 2017
• Primary Completion: July 31, 2019
• Study Completion: January 31, 2020
• Last Updated: September 16, 2020

Record last verified: 2020-09

Locations

IT (1)