NCT05218304

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
5,471

participants targeted

Target at P75+ for not_applicable diabetes

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 26, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2022

Completed
Last Updated

February 1, 2022

Status Verified

January 1, 2022

Enrollment Period

9 months

First QC Date

January 18, 2022

Last Update Submit

January 30, 2022

Conditions

DiabetesHypercholesterolemiaRenal FailureDengue FeverZikaChikungunyaRoss RiverMalariaSARS-CoV InfectionChronic Disease

Keywords

Chronic diseaseDiabetesWHO STEP approachPrevalenceNew Caledonia

Outcome Measures

Primary Outcomes (1)

  • 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.

    Within a year after recruiting the participant

Secondary Outcomes (3)

  • Health behaviors of the target population using the first step of the WHO STEPS survey method.

    Within a year after recruiting the participant

  • 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

Study Arms (2)

Sample

NO INTERVENTION

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

Sub-sample - blood test

EXPERIMENTAL

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

Biological: Blood sample

Interventions

Blood sampleBIOLOGICAL

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

Sub-sample - blood test

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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;

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Agence Sanitaire et Sociale Nouvelle Calédonie

Noumea, 98800, New Caledonia

Location

MeSH Terms

Conditions

Diabetes MellitusHypercholesterolemiaRenal InsufficiencyDengueZika Virus InfectionChikungunya FeverRoss River Virus InfectionMalariaSevere Acute Respiratory SyndromeChronic Disease

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperlipidemiasDyslipidemiasLipid Metabolism DisordersKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesMosquito-Borne DiseasesVector Borne DiseasesInfectionsArbovirus InfectionsVirus DiseasesFlavivirus InfectionsFlaviviridae InfectionsRNA Virus InfectionsHemorrhagic Fevers, ViralAlphavirus InfectionsTogaviridae InfectionsProtozoan InfectionsParasitic DiseasesRespiratory Tract InfectionsCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRespiratory Tract DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: This is an observational, descriptive and cross-sectional study
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2022

First Posted

February 1, 2022

Study Start

July 26, 2021

Primary Completion

April 30, 2022

Study Completion

May 30, 2022

Last Updated

February 1, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will share

Data will be share in new caledonia open data website. Data will be cleaned and anonymized prior sharing in on the open data

Shared Documents
SAP
Time Frame
within 1 year after the study end
Access Criteria
Open access
More information

Locations

NE(1)