CEPPPIA Pilot. Experimental Center of Participative and Individualized Predictive Prevention in Auvergne

NCT ID: NCT03378895

Last Updated: 2019-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

251 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2018-09-28

Brief Summary

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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

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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.

Conditions

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Chronic Disease Cardiovascular Diseases Cancers Diabetes Mellitus Obesity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

No masking

Study Groups

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adults aged 35 to 55 years

Group Type EXPERIMENTAL

online questionnaire

Intervention Type BEHAVIORAL

Risk assessment identified by online questionnaire

Interventions

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online questionnaire

Risk assessment identified by online questionnaire

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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European Regional Development Fund

OTHER

Sponsor Role collaborator

Conseil Régional Auvergne-Rhône-Alpes, Clermont-Ferrand, France.

UNKNOWN

Sponsor Role collaborator

Agence Régionale de Santé Rhône-Alpes

OTHER

Sponsor Role collaborator

Ligue Contre le Cancer, Puy de Dôme, Allier et Cantal

UNKNOWN

Sponsor Role collaborator

GIE Auvergne Thermale

OTHER

Sponsor Role collaborator

Centre Jean Perrin

OTHER

Sponsor Role collaborator

UFR Médecine

UNKNOWN

Sponsor Role collaborator

UFR STAPS

UNKNOWN

Sponsor Role collaborator

Laboratoire d'Informatique, de Modélisation et d'Optimisation des Systèmes (LIMOS)

UNKNOWN

Sponsor Role collaborator

Centre de Recherche en Nutrition Humaine d'Auvergne

OTHER_GOV

Sponsor Role collaborator

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ruddy RICHARD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

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CHU Clermont-Ferrand

Clermont-Ferrand, , France

Site Status

Countries

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France

Other Identifiers

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2017-A00666-47

Identifier Type: OTHER

Identifier Source: secondary_id

CHU-358

Identifier Type: -

Identifier Source: org_study_id

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