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临床试验/NCT05218304
NCT05218304暂停不适用

Baromètre Santé Adulte 2021-2022 in People Aged 18 to 64 in New Caledonia Using the WHO STEPwise Approach

Agence Sanitaire et Sociale de Nouvelle Calédonie2 个研究点 分布在 1 个国家目标入组 5,471 人开始时间: 2021年7月26日最近更新:
适应症

试验速览

阶段
不适用
状态
暂停
发起方
入组人数
5,471
试验地点
2
主要终点
To know the prevalence of the main risk factors chronic diseases (obesity, diabetes, high blood pressure, high cholesterol and kidney failure) in the adult population of New Caledonia aged 18 to 64 using the WHO STEPS survey method.

研究概览

简要总结

In 2021-2022, Agence Sanitaire et Sociale Nouvelle Calédonie (ASSNC) is undertaking the "Baromètre Santé Adulte" for the third time. This study is carried out this year in collaboration with WHO and Institut Pasteur de Nouvelle Calédonie (IPNC).

The main objective of this investigation is to describe the current levels of chronic disease risk factors in the adult population of New Caledonia aged from 18 to 64 years old. This study will also help to estimate prevalence of certain diseases (diabetes, hypercholesterolemia, renal failure), seroprevalence of arboviruses (dengue fever, Zika, chikungunya and Ross River) malaria as well as the seroprevalence of SARS-CoV-2.

Repeated regularly, these surveys allow the ASS-NC to capitalize on population indicators, to compare them according to socio-demographic characteristics, to identify groups at risk, to provide changes in health behaviors and to strengthen analytical capacities in order to adapt the guidelines for public policies and prevention programs.

详细描述

The "Barometre Santé Adulte" is an observational, descriptive and cross-sectional study whose data collection will take place in New Caledonia.

For this study the sampling is based on the 2019 population census, according to a 3-stage stratified sample design. In total, the main sample will consist of approximately 5,500 people (first phase) and the sub-sample will consist of 1,800 people (second phase).

The participation rate is estimated at 60%. Data collection will take place from February to May at the people's place drawn according to two steps:

  • Firstly, investigators will carry out a questionnaire with the people who gave their informed consent as well as taking physical measurements: height, weight, abdominal circumference and blood pressure. In addition to the socio-demographic characteristics of the respondents, the questionnaire deals with several health topics: consumption of psychoactive substances, diet, physical activity, health status and access to care, screening, oral health, driving motor vehicle risk, sexual health, mental health, etc. The time taken to complete the questionnaire is estimated at one hour.
  • Secondly, and for a sub-sample of 1,800 people, nurses will come back to the people's places who volunteer to take a venous blood test: blood sugar, total cholesterol, HbA1c, serum creatinine, CBC and serology of diseases transmitted by mosquitoes (dengue, chikungunya, Zika and Ross River, malaria).

All the data collected will be entered on a tablet in the eSTEPS application. The analysis of data (R Studio software) and the drafting of the report will be carried out by ASSNC staff. The first results are expected for the second half of 2022.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Individuals informed of the conduct of the research and having given their written consent to participate in the study (questionnaire and taking physical measurements);
  • Individuals between the ages of 18 and 64;
  • Individuals residing in New Caledonia in so-called "ordinary" housing under their main residence at the last population census in 2019;

排除标准

  • Pregnant or breastfeeding women;
  • Tourists and transients staying in New Caledonia for less than 6 months at the time of the investigation;
  • People who are not intellectually fit to answer the questionnaire;
  • Persons subject to guardianship, curatorship or any other legal incapacity;
  • For the second phase of the study will be excluded people describing a febrile syndrome;

结局指标

主要结局

To know the prevalence of the main risk factors chronic diseases (obesity, diabetes, high blood pressure, high cholesterol and kidney failure) in the adult population of New Caledonia aged 18 to 64 using the WHO STEPS survey method.

时间窗: Within a year after recruiting the participant

In order to measure the prevalence of the main risk factors chronic diseases, WHO STEPS method will be used. This questionnaire is a 3 steps method, the first steps is a questionnaire mainly based on medical history and health behaviors. The second steps is associated with taking physical measurements such as weight, height, blood pressure, waist size. The last steps concerned only the experimental group "the sub-sample" for which some blood sample will be drawn out for the detection of elevated levels of blood glucose, HbA1c, total cholesterol and serum creatinine.

次要结局

  • To calculate the cardiovascular risk of the New Caledonian population using the SCORE projet(Within a year after recruiting the participant)
  • Seroprevalence of infectious diseases(Within a year after recruiting the participant)
  • Health behaviors of the target population using the first step of the WHO STEPS survey method.(Within a year after recruiting the participant)

研究者

发起方
Agence Sanitaire et Sociale de Nouvelle Calédonie
申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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