Clinical trial NCT03378895: CEPPPIA Pilot. Experimental Center of Participative and Individualized Predictive Prevention in Auvergne
Official title: CEPPPIA Pilot. Experimental Center of Participative and Individualized Predictive Prevention in Auvergne
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Disease
Cardiovascular Diseases
Cancers
Diabetes Mellitus
Obesity
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: European Regional Development Fund
name: Conseil Régional Auvergne-Rhône-Alpes, Clermont-Ferrand, France.
name: Agence Régionale de Santé Rhône-Alpes
name: Ligue Contre le Cancer, Puy de Dôme, Allier et Cantal
name: GIE Auvergne Thermale
name: Centre Jean Perrin
name: UFR Médecine
name: UFR STAPS
name: Laboratoire d'Informatique, de Modélisation et d'Optimisation des Systèmes (LIMOS)
name: Centre de Recherche en Nutrition Humaine d'Auvergne
First posted: 2017-12-20
Enrollment: 251
Sex: ALL
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The state of health in France appears to be good with regard to major indicators such as life expectancy at birth.

However, France is characterized by a high standardized rate of premature mortality (deaths occurring before the age of 65) in comparison with other European countries, with geographical disparities. Between 2006 and 2010, the standardized rate of premature mortality was higher in Auvergne than the national average.

Chronic diseases such as cardiovascular diseases, cancers and / or metabolic diseases (including diabetes and obesity) are the main causes of these premature deaths. These diseases have several causes: they depend on the genetic heritage, the way of life and the environment. Family history is a known risk factor for these chronic diseases. Eating habits, insufficient physical activity or physical inactivity, excessive drinking and smoking which promote the occurrence of these chronic diseases are the main risk factors that we can modify. Preventive measures are known and are regularly the subject of public health plans and awareness campaigns targeting lifestyles modification of the populations. These prevention campaigns affect entire population, while the risk factors for chronic diseases are different from one to another, this encourages personalization of preventive measures. The CEPPPIA pilot study falls within this framework and aims to evaluate the feasibility of setting up an individualized prevention program on the modification of health behaviors among people aged 35 to 55, who has a moderate risk of developing chronic diseases and residing in Auvergne territory.

Detailed description: The state of health in France appears to be good with regard to major indicators such as life expectancy at birth.

However, France is characterized by a high standardized rate of premature mortality (deaths occurring before the age of 65) in comparison with other European countries, with geographical disparities. Between 2006 and 2010, the standardized rate of premature mortality was higher in Auvergne than the national average.

Chronic diseases such as cardiovascular diseases, cancers and / or metabolic diseases (including diabetes and obesity) are the main causes of these premature deaths. These diseases have several causes: they depend on the genetic heritage, the way of life and the environment. Family history is a known risk factor for these chronic diseases. Eating habits, insufficient physical activity or physical inactivity, excessive drinking and smoking which promote the occurrence of these chronic diseases are the main risk factors that we can modify. Preventive measures are known and are regularly the subject of public health plans and awareness campaigns targeting lifestyles modification of the populations. These prevention campaigns affect entire population, while the risk factors for chronic diseases are different from one to another, this encourages personalization of preventive measures. The CEPPPIA pilot study falls within this framework and aims to evaluate the feasibility of setting up an individualized prevention program on the modification of health behaviors among people aged 35 to 55, who has a moderate risk of developing chronic diseases and residing in Auvergne territory.

Eligibility criteria: Inclusion Criteria:

* Men or women aged 35 to 55 years
* Subjects identified as moderate risk (group G1) following the assessment of the level of risk
* Covered by the Social Security
* Having signed the information form and having given his / her free consent during the inclusion visit
* Judged able to understand the aims of the study and ready to accept the constraints

Exclusion Criteria:

* Age \<35 years or\> 55 years
* Person who has not completed and validated the FSI (online health questionnaire)
* Person belonging to group G1 but with a moderate pathological risk (P1) and no identifiable risk in the behavioral field (C0)
* Pregnant or lactating women
* Persons benefiting from a legal protection measure
* Persons refusing to sign information and consent form
* Person in an exclusion period from another study, or having received more than 4500 € in the year
* Person deprived of his liberty by judicial or administrative decision
* Medical or surgical history, judged by the investigator to be incompatible with the study
* Suspicion of psychiatric disorders judged by the investigator to be incompatible with the study

Primary outcomes:
measure: Individualized Prevention Program participation rate
timeFrame: at day 1
Secondary outcomes:
measure: Variation of the risk score in at least one of the three behavioral domains
timeFrame: at day 1
measure: Variation of the risk score in at least one of the three behavioral domains; The risk score will be calculated from the results reported on a self-administered questionnaire
timeFrame: at 3 month
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Ruddy RICHARD
role: PRINCIPAL_INVESTIGATOR
References: