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

Obesity Clinical Trial

— CEPPPIA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03378895
• Other study ID #: CHU-358
• Secondary ID: 2017-A00666-47
• Status: Completed
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: September 28, 2018

Study information

• Verified date: January 2019
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 251
• Est. completion date: September 28, 2018
• Est. primary completion date: September 28, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancers
• Cardiovascular Diseases
• Chronic Disease
• Diabetes Mellitus
• Obesity

Intervention

Behavioral:
• online questionnaire
Risk assessment identified by online questionnaire

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (11)

Lead Sponsor

Collaborator

University Hospital, Clermont-Ferrand

Agence Régionale de Santé Auvergne-Rhône-Alpes, Lyon, Centre de Recherche en Nutrition Humaine d'Auvergne, Centre Jean Perrin, Conseil Régional Auvergne-Rhône-Alpes, Clermont-Ferrand, France., European Regional Development Fund, GIE Auvergne Thermale, Laboratoire d’Informatique, de Modélisation et d’Optimisation des Systèmes (LIMOS), Ligue Contre le Cancer, Puy de Dôme, Allier et Cantal, UFR Médecine, UFR STAPS

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Individualized Prevention Program participation rate	Number of volunteers who accepted to participate in the interventional phase / number of volunteers who can be included in the study Assess the feasibility of implementing an Individualized Prevention Program on the modification of health behaviors among people aged 35 to 55 years with a risk of developing chronic diseases (cardiovascular diseases, metabolic diseases and / or cancers) and residing in the territory of Auvergne by measuring partipation rate and satisfaction	at day 1
Secondary	Variation of the risk score in at least one of the three behavioral domains	Evaluation of the effectiveness of an individualized primary prevention program on changing health behaviors among people aged 35 to 55 years with a risk of developing chronic diseases (cardiovascular diseases, metabolic diseases and/or cancers)	at day 1
Secondary	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	Evaluate the effectiveness of an individualized primary prevention program on the modification of health behaviors among people aged 35 to 55, at risk of developing chronic diseases (cardiovascular diseases, metabolic diseases and / or cancers) and residing in Auvergne.	at 3 month