CEPPPIA Pilot. Experimental Center of Participative and Individualized Predictive Prevention in Auvergne (CEPPPIA)
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| ClinicalTrials.gov Identifier: NCT03378895 |
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Recruitment Status :
Completed
First Posted : December 20, 2017
Last Update Posted : January 25, 2019
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Disease Cardiovascular Diseases Cancers Diabetes Mellitus Obesity | Behavioral: online questionnaire | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 251 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Masking Description: | No masking |
| Primary Purpose: | Prevention |
| Official Title: | CEPPPIA Pilot. Experimental Center of Participative and Individualized Predictive Prevention in Auvergne |
| Actual Study Start Date : | December 1, 2017 |
| Actual Primary Completion Date : | September 28, 2018 |
| Actual Study Completion Date : | September 28, 2018 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: adults aged 35 to 55 years |
Behavioral: online questionnaire
Risk assessment identified by online questionnaire |
- Individualized Prevention Program participation rate [ Time Frame: at day 1 ]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
- Variation of the risk score in at least one of the three behavioral domains [ Time Frame: at day 1 ]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)
- 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 [ Time Frame: at 3 month ]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.
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| Ages Eligible for Study: | 35 Years to 55 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03378895
| France | |
| CHU Clermont-Ferrand | |
| Clermont-Ferrand, France, 63003 | |
| Principal Investigator: | Ruddy RICHARD | University Hospital, Clermont-Ferrand |
| Responsible Party: | University Hospital, Clermont-Ferrand |
| ClinicalTrials.gov Identifier: | NCT03378895 |
| Other Study ID Numbers: |
CHU-358 2017-A00666-47 ( Other Identifier: 2017-A00666-47 ) |
| First Posted: | December 20, 2017 Key Record Dates |
| Last Update Posted: | January 25, 2019 |
| Last Verified: | January 2019 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Cardiovascular Diseases Chronic Disease Disease Attributes Pathologic Processes |