Clinical trial NCT05218304: Baromètre Santé Adulte 2021-2022
Official title: Baromètre Santé Adulte 2021-2022 in People Aged 18 to 64 in New Caledonia Using the WHO STEPwise Approach
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Diabetes
Hypercholesterolemia
Renal Failure
Dengue Fever
Zika
Chikungunya
Ross River
Malaria
SARS-CoV Infection
Chronic Disease
Keywords: Chronic disease
Diabetes
WHO STEP approach
Prevalence
New Caledonia
Lead sponsor: Agence Sanitaire et Sociale de Nouvelle Calédonie
Sponsor class: OTHER_GOV
Collaborators: name: Institut Pasteur
name: Pacific Community
name: World Health Organization
name: Institut de la Statitique et des Etudes Economiques Nouvelle Calédonie
First posted: 2022-02-01
Enrollment: 5471
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is an observational, descriptive and cross-sectional study
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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;

Exclusion Criteria:

* 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;

Primary outcomes:
measure: 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.
timeFrame: Within a year after recruiting the participant
Secondary outcomes:
measure: Health behaviors of the target population using the first step of the WHO STEPS survey method.
timeFrame: Within a year after recruiting the participant
measure: To calculate the cardiovascular risk of the New Caledonian population using the SCORE projet
timeFrame: Within a year after recruiting the participant
measure: Seroprevalence of infectious diseases
timeFrame: Within a year after recruiting the participant
Other outcomes:
Locations:
city: Nouméa
country: New Caledonia
facility: Agence Sanitaire et Sociale Nouvelle Calédonie
Study officials:
References: