跳至主要内容
临床试验/NCT03378895
NCT03378895已完成不适用

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

University Hospital, Clermont-Ferrand1 个研究点 分布在 1 个国家目标入组 251 人开始时间: 2017年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
251
试验地点
1
主要终点
Individualized Prevention Program participation rate

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

盲法说明

No masking

入排标准

年龄范围
35 Years 至 55 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

adults aged 35 to 55 years

Experimental

干预措施: online questionnaire (Behavioral)

结局指标

主要结局

Individualized Prevention Program participation rate

时间窗: 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

次要结局

  • Variation of the risk score in at least one of the three behavioral domains(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(at 3 month)

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

研究点 (1)

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