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

Primary Purpose

Chronic Disease, Cardiovascular Diseases, Cancers

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
online questionnaire
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Disease

Eligibility Criteria

35 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CHU Clermont-Ferrand

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

adults aged 35 to 55 years

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)
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.

Full Information

First Posted
October 17, 2017
Last Updated
January 24, 2019
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
European Regional Development Fund, Conseil Régional Auvergne-Rhône-Alpes, Clermont-Ferrand, France., Agence Régionale de Santé Rhône-Alpes, Ligue Contre le Cancer, Puy de Dôme, Allier et Cantal, GIE Auvergne Thermale, Centre Jean Perrin, UFR Médecine, UFR STAPS, Laboratoire d'Informatique, de Modélisation et d'Optimisation des Systèmes (LIMOS), Centre de Recherche en Nutrition Humaine d'Auvergne
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1. Study Identification

Unique Protocol Identification Number
NCT03378895
Brief Title
CEPPPIA Pilot. Experimental Center of Participative and Individualized Predictive Prevention in Auvergne
Acronym
CEPPPIA
Official Title
CEPPPIA Pilot. Experimental Center of Participative and Individualized Predictive Prevention in Auvergne
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
September 28, 2018 (Actual)
Study Completion Date
September 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
European Regional Development Fund, Conseil Régional Auvergne-Rhône-Alpes, Clermont-Ferrand, France., Agence Régionale de Santé Rhône-Alpes, Ligue Contre le Cancer, Puy de Dôme, Allier et Cantal, GIE Auvergne Thermale, Centre Jean Perrin, UFR Médecine, UFR STAPS, Laboratoire d'Informatique, de Modélisation et d'Optimisation des Systèmes (LIMOS), Centre de Recherche en Nutrition Humaine d'Auvergne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease, Cardiovascular Diseases, Cancers, Diabetes Mellitus, Obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
No masking
Allocation
N/A
Enrollment
251 (Actual)

8. Arms, Groups, and Interventions

Arm Title
adults aged 35 to 55 years
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
online questionnaire
Intervention Description
Risk assessment identified by online questionnaire
Primary Outcome Measure Information:
Title
Individualized Prevention Program participation rate
Description
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
Time Frame
at day 1
Secondary Outcome Measure Information:
Title
Variation of the risk score in at least one of the three behavioral domains
Description
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)
Time Frame
at day 1
Title
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
Description
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.
Time Frame
at 3 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruddy RICHARD
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France

12. IPD Sharing Statement

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

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