ClinicalTrials.gg
CompletedNCT03378895CEPPPIAUpdated Jan 25, 2019

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

An interventional study of online questionnaire in Chronic Disease, Cardiovascular Diseases and Cancers, sponsored by University Hospital, Clermont-Ferrand. Completed at 1 site in France. Open to participants aged 35 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-25.

Primary conditionCardiovascular DiseasesRegistry: Chronic DiseaseReclassifiedWhy we changed it
Registry
Chronic Disease — the first condition term the registry derived for this study.
ClinicalTrials.gg
Cardiovascular Diseases
Why
  1. Chronic Disease is a broad heading, used only when no more specific condition is named.
  2. The study's listed conditions name Cardiovascular Diseases.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by University Hospital, Clermont-Ferrand · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
251
Allocation
Not applicable
Ages
35 Years to 55 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Chronic Disease
  • Cardiovascular Diseases
  • Cancers
  • Diabetes Mellitus
  • Obesity
03

In context

Cardiovascular Diseases Reclassified

5,368 studies on the registry are indexed under Cardiovascular Diseases; 939 are open to participants now.

This study's enrollment of 251 is above the median of 100 across 3,084 interventional studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

University Hospital, Clermont-Ferrand is the lead sponsor of 859 studies on the registry; 179 are open to participants now.

Compared within Cardiovascular Diseases, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Chronic Disease. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
35 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
251 participants (actual)

Study arms

  • Experimental
    adults aged 35 to 55 years

    Behavioral: online questionnaire

Interventions

  • Behavioralonline questionnaire

    Risk assessment identified by online questionnaire

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: at day 1

Secondary outcomes

  1. 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)

    Time frame: at day 1

  2. 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.

    Time frame: at 3 month

07

Study locations

1 site
  • CHU Clermont-Ferrand
    Clermont-Ferrand, 63003, France
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2017 to primary completion in Sep 2018, 9 months.

Of 1,077 non-industry interventional studies with no phase under Cardiovascular Diseases, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's 9 months is below that.

Counting every sponsor, half of 1,216 studies reached it within 26 months; a quarter within 12 and three quarters within 49.

Cardiovascular Diseases covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 17, 2017
First posted
Dec 20, 2017
StartActual
Dec 1, 2017
Primary completionActual
Sep 28, 2018
CompletionActual
Sep 28, 2018
Last update
Jan 25, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 25, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03378895
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
Responsible party
Sponsor
First posted
Dec 20, 2017
Start date
Dec 1, 2017
Primary completion
Sep 28, 2018
Completion
Sep 28, 2018
Last update
Jan 25, 2019

Study contacts

Ruddy RICHARD
principal investigator · University Hospital, Clermont-Ferrand

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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