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Baromètre Santé Adulte 2021-2022

Primary Purpose

Diabetes, Hypercholesterolemia, Renal Failure

Status
Suspended
Phase
Not Applicable
Locations
New Caledonia
Study Type
Interventional
Intervention
Blood sample
Sponsored by
Agence Sanitaire et Sociale de Nouvelle Calédonie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabetes focused on measuring Chronic disease, Diabetes, WHO STEP approach, Prevalence, New Caledonia

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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;

Sites / Locations

  • Agence Sanitaire et Sociale Nouvelle Calédonie

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Sample

Sub-sample - blood test

Arm Description

questionnaires physical measurements (height, weight, perimeter abdominal and blood pressure)

questionnaires physical measurements (height, weight, perimeter abdominal and blood pressure) Blood samples

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Health behaviors of the target population using the first step of the WHO STEPS survey method.
To correlate health data and everyday behaviors of the target population in order to show a trend in causal effect, in order to have specific health indicators up to date
To calculate the cardiovascular risk of the New Caledonian population using the SCORE projet
To calculate the cardiovascular risk based on systolic blood pressure, sex, smoking status and cholesterol level.
Seroprevalence of infectious diseases
To Determine the seroprevalence of dengue, Zika, chikungunya and Ross River arboviruses in New Caledonia, the seroprevalence against the malaria agent as well as the seroprevalence of SARS-CoV-2.

Full Information

First Posted
January 18, 2022
Last Updated
January 30, 2022
Sponsor
Agence Sanitaire et Sociale de Nouvelle Calédonie
Collaborators
Institut Pasteur, Pacific Community, World Health Organization, Institut de la Statitique et des Etudes Economiques Nouvelle Calédonie
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1. Study Identification

Unique Protocol Identification Number
NCT05218304
Brief Title
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

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Suspended
Why Stopped
Lockdown in the general population due to COVID
Study Start Date
July 26, 2021 (Actual)
Primary Completion Date
April 30, 2022 (Anticipated)
Study Completion Date
May 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Agence Sanitaire et Sociale de Nouvelle Calédonie
Collaborators
Institut Pasteur, Pacific Community, World Health Organization, Institut de la Statitique et des Etudes Economiques Nouvelle Calédonie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is an observational, descriptive and cross-sectional study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
5471 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sample
Arm Type
No Intervention
Arm Description
questionnaires physical measurements (height, weight, perimeter abdominal and blood pressure)
Arm Title
Sub-sample - blood test
Arm Type
Experimental
Arm Description
questionnaires physical measurements (height, weight, perimeter abdominal and blood pressure) Blood samples
Intervention Type
Biological
Intervention Name(s)
Blood sample
Intervention Description
A questionnaire, physical measurements (height, weight, perimeter abdominal and blood pressure) for all arm will be done, approximately 5400 people carried out by investigators. Only 1800 will undergo blood samples carried out by nurses
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
Within a year after recruiting the participant
Secondary Outcome Measure Information:
Title
Health behaviors of the target population using the first step of the WHO STEPS survey method.
Description
To correlate health data and everyday behaviors of the target population in order to show a trend in causal effect, in order to have specific health indicators up to date
Time Frame
Within a year after recruiting the participant
Title
To calculate the cardiovascular risk of the New Caledonian population using the SCORE projet
Description
To calculate the cardiovascular risk based on systolic blood pressure, sex, smoking status and cholesterol level.
Time Frame
Within a year after recruiting the participant
Title
Seroprevalence of infectious diseases
Description
To Determine the seroprevalence of dengue, Zika, chikungunya and Ross River arboviruses in New Caledonia, the seroprevalence against the malaria agent as well as the seroprevalence of SARS-CoV-2.
Time Frame
Within a year after recruiting the participant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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;
Facility Information:
Facility Name
Agence Sanitaire et Sociale Nouvelle Calédonie
City
Nouméa
ZIP/Postal Code
98800
Country
New Caledonia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be share in new caledonia open data website. Data will be cleaned and anonymized prior sharing in on the open data
IPD Sharing Time Frame
within 1 year after the study end
IPD Sharing Access Criteria
Open access
IPD Sharing URL
http://data.gouv.nc/pages/accueil/?flg=fr

Learn more about this trial

Baromètre Santé Adulte 2021-2022

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