Chronic DiseaseCEPPPIANCT03378895
CEPPPIA Pilot. Experimental Center of Participative and Individualized Predictive Prevention in Auvergne
A study testing online questionnaire in people with Chronic Disease and Cardiovascular Diseases, run by University Hospital, Clermont-Ferrand at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 35 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Disease, Cardiovascular Diseases, Cancers
- What is being tested?
- online questionnaire
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 251 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2017to 28 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Chronic Disease, Cardiovascular Diseases, Cancers, Diabetes Mellitus, Obesity
- Being tested
- online questionnaire
- Medical subject headings
- Chronic Disease, Cardiovascular Diseases, Neoplasms, Diabetes Mellitus, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
online questionnaireBehavioural
Risk assessment identified by online questionnaire
| Study group | Role | What they receive |
|---|---|---|
| adults aged 35 to 55 years | Experimental | Not described Receives: Behavioral: online questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at day 1
Secondary outcomes (2)
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)
Measured: at day 1
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.
Measured: at 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2017
- Study start1 Dec 2017
- Primary completion28 Sep 2018
- Study completion28 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 251 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- 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
- Investigators
- Ruddy RICHARD, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03378895
- Sponsor's protocol ID
- CHU-358
- Other IDs
- 2017-A00666-47
- Acronym
- CEPPPIA
- Status last verified
- Jan 2019
- First submitted
- 17 Oct 2017
- Last updated
- 25 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CEPPPIA Pilot. Experimental Center of Participative and Individualized Predictive Prevention in Auvergne
- ClinicalTrials.gov ID
- NCT03378895
- Acronym / sponsor ID
- CEPPPIA / CHU-358
- Conditions
- Chronic Disease, Cardiovascular Diseases, Cancers, Diabetes Mellitus, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 251 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- 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
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 28 Sep 2018 (actual)
- Study completion
- 28 Sep 2018 (actual)
- First posted
- 20 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adults aged 35 to 55 years | Experimental | Behavioral: online questionnaire |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| online questionnaireRisk assessment identified by online questionnaire | Behavioural | adults aged 35 to 55 years |
Primary outcome
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
2 secondary outcomes
Variation of the risk score in at least one of the three behavioral domains
Time frame: at day 1
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruddy RICHARD principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing online questionnaire in people with Chronic Disease and Cardiovascular Diseases, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Individualized Prevention Program participation rate (time frame: at day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2019.