Economic Crisis and Adherence to the Mediterranean Diet (CASSIOPEA)

Obesity Clinical Trial

— CASSIOPEA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03119142
• Other study ID #: 5/17
• Status: Completed
• Start date: May 2, 2017
• Est. completion date: January 31, 2020

Study information

• Verified date: September 2020
• Source: Neuromed IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

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.

Experimental Design Aim 2: Within the two groups identified in aim 1, aim 2 will:

1. Perform a dietary follow up by administering the Italian version of the EPIC questionnaire (9), already used at baseline, to estimate the changes in dietary habits. Lifestyle follow up will be obtained by a validated questionnaire used at baseline.

2. Assess changes in inflammatory status by measurements of the following biomarkers:

High-sensitivity C-reactive protein, Interleukin-6, Interleukin-18, Tumor necrosis factor, Plasminogen activator inhibitor-1, VCAM, ICAM, P-selectin, E-selectin, L-selectin, CD40L, adiponectin, platelet and leukocyte counts, lipids, triglycerides, glucose, insulin.

3. Estimate variations in the metabolic phenotypes (prevalence of hypertension, diabetes, obesity, metabolic syndrome, and levels of blood pressure, hip and waist circumferences).

Experimental Design Aim 3: A validated questionnaire on nutrition knowledge and exposure to mass media will be administered. This will allow to retrospectively identify additional subgroups differently exposed to information in order to estimate the role of cultural resources in health-related behavioural changes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3646
• Est. completion date: January 31, 2020
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Italy	Irccs Neuromed	Campobasso

Sponsors (1)

Lead Sponsor	Collaborator
Neuromed IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Obesity	Body mass index (BMI) will be obtained by dividing weight in kilograms (kg) by height (meters) squared. Obesity will be defined according to the following BMI categories: Underweight = <18.5; Normal weight = 18.5-24.9; Overweight = 25-29.9; Obesity = BMI of 30 or greater.	The follow-up is of 10 years since baseline enrolment (2005-2010)
Secondary	Hypertension	Hypertension will be defined as systolic blood pressure =140 mm Hg or diastolic blood pressure =90 mm Hg or treatment for hypertension.	The follow-up is of 10 years since baseline enrolment (2005-2010)
Secondary	Hypercholesterolemia	Hypercholesterolemia will be defined if total cholesterol =240 mg/dl or by use of specific medication.	The follow-up is of 10 years since baseline enrolment (2005-2010)
Secondary	Diabetes	Diabetes will be defined as blood glucose =126 mg/dl or by use of specific pharmacological treatment.	The follow-up is of 10 years since baseline enrolment (2005-2010)
Secondary	Inflammation	Inflammatory status will be assessed by measurements of the following biomarkers: High-sensitivity C-reactive protein, Interleukin-6, Interleukin-18, Tumor necrosis factor, Plasminogen activator inhibitor-1, VCAM, ICAM, P-selectin, E-selectin, L-selectin, CD40L, adiponectin, platelet and leukocyte counts, lipids, triglycerides, glucose, insulin.	The follow-up is of 10 years since baseline enrolment (2005-2010)