NCT06133400

Brief Summary

This is a cross-sectional study carried out on a sample of the adult population aged 18 to 69, distributed over the five archipelagos of French Polynesia. Participation in the study involves: agreement to answer a questionnaire to collect information on socio-demographic characteristics, lifestyle habits and medical history; physical measurements (height, weight, waist circumference, blood pressure and skin pigmentation); and agreement to take biological samples (blood, saliva and stool) for biological, genetic and microbiological analyses. The aim of the study is to assess the current health status of the population of French Polynesia and to evaluate the influence of contextual risk factors (lifestyle, place of residence, history of infection) and intrinsic susceptibility factors (genetics, age, gender, microbiota) in relation to non-communicable and infectious diseases.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,942

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

November 4, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 8, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2021

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

October 30, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 15, 2023

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

2.1 years

First QC Date

October 30, 2023

Last Update Submit

November 15, 2023

Conditions

Keywords

cross-sectional surveynon-communicable diseasecommunicable diseaseFrench Polynesiapopulation genetics

Outcome Measures

Primary Outcomes (16)

  • Prevalence of obesity

    Proportion of participants with indicators of obesity based on physical measurements (BMI, waist circumference) and quantification of lipid levels from blood samples.

    2 years

  • Prevalence of diabetes

    Proportion of participants with indicators of diabetes based on self-reported data on diabetes history (previous diagnosis, antidiabetic treatment) and quantification of glycated haemoglobin from blood samples.

    2 years

  • Prevalence of cardiovascular diseases

    Proportion of participants with indicators of cardiovascular diseases based on self-reported data on history of hypertension (previous diagnosis, treatment for hypertension), blood pressure measurement, and quantification of lipid levels from blood samples.

    2 years

  • Association between non-communicable diseases and behavioral factors

    Calculation of odd ratios to investigate association between non-communicable diseases (obesity, diabetes, cardiovascular diseases) and behavioral factors such as tobacco smoking, alcohol consumption, diet or physical activity data self-reported by the participants in the questionnaire.

    2 years

  • Association between non-communicable diseases and physical measurements

    Calculation of odd ratios to investigate association between non-communicable diseases (obesity, diabetes, cardiovascular diseases) and physical measurements such as BMI (based on the BMI formula i.e., weight in kilograms divided by height in meters squared).

    2 years

  • Association between non-communicable diseases and blood analyses

    Calculation of odd ratios to investigate association between non-communicable diseases (obesity, diabetes, cardiovascular diseases) and blood analyses (such as glycated haemoglobin and lipid levels).

    2 years

  • Seroprevalence of communicable diseases

    Proportion of participants with IgG antibodies, detected in blood samples, specific for different pathogens : arboviruses (four dengue serotypes, Zika, chikungunya), hepatitis B and C viruses, hantaviruses, SARS-CoV-2 and other pathogens known to regularly cause infections in French Polynesia (including influenza viruses, human immunodeficiency virus…). Proportion of participants with positive filarial antigenemia to assess the prevalence of Bancroftian lymphatic filariasis.

    2 years

  • Composition of microbiome

    Bacterial DNA sequencing from stool and saliva samples to assess the gut and oral microbiota profiles and association with lifestyle behavior, diet and susceptibility to communicable and non-communicable diseases.

    2 years

  • Level of exposure to heavy metals

    Quantification of levels of heavy metals (including mercury and lead) from blood samples and association with lifestyle behavior and diet.

    2 years

  • Level of exposure to pesticides

    Quantification of levels of pesticides (including chlordane and toxaphene) from blood samples and association with lifestyle behavior and diet.

    2 years

  • Level of exposure to mosquito bites

    Proportion of participants with IgG antibodies targeting mosquito salivary proteins in blood samples to assess the risk of infection by mosquito-borne viruses

    2 years

  • Prevalence of ciguatera poisoning

    Estimation of the rate of ciguatera poisoning in the population based on data self-reported by the participants in the questionnaire e.g. the occurrence of symptoms suggestive for ciguatera poisoning at least once in their lifetime

    2 years

  • Demographic and adaptive history of French Polynesians using genomics

    Human Whole Genome Sequencing from saliva samples to reconstruct the genetic history of the population of French Polynesia, in terms of both demographic and adaptive history.

    2 years

  • Genetic susceptibility to obesity

    Genome-wide association studies to identify human genetic factors that are associated with BMI or lipids levels.

    2 years

  • Genetic susceptibility to diabetes

    Genome-wide association studies to identify human genetic factors that are associated with HbA1c.

    2 years

  • Genetic susceptibility to communicable diseases

    Genome-wide association studies to identify human genetic factors that are associated with the detection of IgG antibodies specific for different pathogens: arboviruses, hepatitis B and C viruses, hantaviruses, SARS-CoV-2 and other pathogens known to regularly cause infections in French Polynesia (including influenza viruses, human immunodeficiency virus…).

    2 years

Study Arms (1)

Subjects representative of the adult population (18-69 y) of French Polynesia

EXPERIMENTAL

Population sample composed of people aged 18 to 69. These people must have been living in French Polynesia for more than two years at the time of the 2017 census

Other: QuestionnaireOther: Physical measurementsOther: Biological samples

Interventions

Questionnaire about socio-demographical status, health status and lifestyle habits

Subjects representative of the adult population (18-69 y) of French Polynesia

Measurement of height, weight, waist circumference, blood pressure and skin pigmentation

Subjects representative of the adult population (18-69 y) of French Polynesia

Collect venous blood, saliva and stool samples

Subjects representative of the adult population (18-69 y) of French Polynesia

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • be aged 18 or over and under 70 on the date of recruitment
  • having signed the consent form

You may not qualify if:

  • Minors
  • Pregnant or parturient women, and nursing mothers
  • Persons deprived of their liberty by a judicial or administrative decision
  • Adults who are the subject of a legal protection measure or who are unable to express their consent
  • People undergoing psychiatric care
  • Individuals who are not affiliated to a social security scheme or beneficiaries of such a scheme
  • Homeless people
  • Disabled people (unable to move)
  • People unable to answer the questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Louis Malardé

Papeete, Îles du Vent, 98713, French Polynesia

Location

Related Publications (1)

  • Teiti I, Aubry M, Fernandes-Pellerin S, Patin E, Madec Y, Boucheron P, Vanhomwegen J, Torterat J, Lastere S, Olivier S, Jaquaniello A, Roux M, Mendiboure V, Harmant C, Bisiaux A, Rijo de Leon G, Liu D, Bossin H, Mathieu-Daude F, Gatti C, Suhas E, Chung K, Condat B, Ayotte P, Conte E, Jolly N, Manuguerra JC, Sakuntabhai A, Fontanet A, Quintana-Murci L, Cao-Lormeau VM. Unravelling the determinants of human health in French Polynesia: the MATAEA project. Front Epidemiol. 2023 Nov 27;3:1201038. doi: 10.3389/fepid.2023.1201038. eCollection 2023.

MeSH Terms

Conditions

Noncommunicable DiseasesCommunicable DiseasesHeavy Metal PoisoningCiguatera Poisoning

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsInfectionsPoisoningChemically-Induced DisordersFoodborne Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Van-Mai CAO-LORMEAU, PhD

    Institut Louis Malardé

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2023

First Posted

November 15, 2023

Study Start

November 4, 2019

Primary Completion

December 8, 2021

Study Completion

December 8, 2021

Last Updated

November 18, 2023

Record last verified: 2023-11

Locations