Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2026-01-02 @ 1:56 AM
Study NCT ID:
NCT05218304
Status:
SUSPENDED
Last Update Posted:
2022-02-01
First Post:
2022-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Baromètre Santé Adulte 2021-2022
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D006937', 'term': 'Hypercholesterolemia'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D003715', 'term': 'Dengue'}, {'id': 'D000071243', 'term': 'Zika Virus Infection'}, {'id': 'D065632', 'term': 'Chikungunya Fever'}, {'id': 'D000096745', 'term': 'Ross River Virus Infection'}, {'id': 'D008288', 'term': 'Malaria'}, {'id': 'D045169', 'term': 'Severe Acute Respiratory Syndrome'}, {'id': 'D002908', 'term': 'Chronic Disease'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D000096724', 'term': 'Mosquito-Borne Diseases'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001102', 'term': 'Arbovirus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018177', 'term': 'Flavivirus Infections'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006482', 'term': 'Hemorrhagic Fevers, Viral'}, {'id': 'D018354', 'term': 'Alphavirus Infections'}, {'id': 'D014036', 'term': 'Togaviridae Infections'}, {'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is an observational, descriptive and cross-sectional study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5471}}, 'statusModule': {'whyStopped': 'Lockdown in the general population due to COVID', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2021-07-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-30', 'studyFirstSubmitDate': '2022-01-18', 'studyFirstSubmitQcDate': '2022-01-30', 'lastUpdatePostDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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', '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.'}], 'secondaryOutcomes': [{'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', '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'}, {'measure': 'To calculate the cardiovascular risk of the New Caledonian population using the SCORE projet', 'timeFrame': 'Within a year after recruiting the participant', 'description': 'To calculate the cardiovascular risk based on systolic blood pressure, sex, smoking status and cholesterol level.'}, {'measure': 'Seroprevalence of infectious diseases', 'timeFrame': 'Within a year after recruiting the participant', '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic disease', 'Diabetes', 'WHO STEP approach', 'Prevalence', 'New Caledonia'], 'conditions': ['Diabetes', 'Hypercholesterolemia', 'Renal Failure', 'Dengue Fever', 'Zika', 'Chikungunya', 'Ross River', 'Malaria', 'SARS-CoV Infection', 'Chronic Disease']}, 'descriptionModule': {'briefSummary': '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).\n\nThe 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.\n\nRepeated 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.', 'detailedDescription': 'The "Barometre Santé Adulte" is an observational, descriptive and cross-sectional study whose data collection will take place in New Caledonia.\n\nFor 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).\n\nThe 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:\n\n* 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.\n* 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).\n\nAll 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals informed of the conduct of the research and having given their written consent to participate in the study (questionnaire and taking physical measurements);\n* Individuals between the ages of 18 and 64;\n* Individuals residing in New Caledonia in so-called "ordinary" housing under their main residence at the last population census in 2019;\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women;\n* Tourists and transients staying in New Caledonia for less than 6 months at the time of the investigation;\n* People who are not intellectually fit to answer the questionnaire;\n* Persons subject to guardianship, curatorship or any other legal incapacity;\n* For the second phase of the study will be excluded people describing a febrile syndrome;'}, 'identificationModule': {'nctId': 'NCT05218304', 'briefTitle': 'Baromètre Santé Adulte 2021-2022', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Agence Sanitaire et Sociale de Nouvelle Calédonie'}, 'officialTitle': 'Baromètre Santé Adulte 2021-2022 in People Aged 18 to 64 in New Caledonia Using the WHO STEPwise Approach', 'orgStudyIdInfo': {'id': '2021-A01260-41'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Sample', 'description': 'questionnaires physical measurements (height, weight, perimeter abdominal and blood pressure)'}, {'type': 'EXPERIMENTAL', 'label': 'Sub-sample - blood test', 'description': 'questionnaires physical measurements (height, weight, perimeter abdominal and blood pressure) Blood samples', 'interventionNames': ['Biological: Blood sample']}], 'interventions': [{'name': 'Blood sample', 'type': 'BIOLOGICAL', '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', 'armGroupLabels': ['Sub-sample - blood test']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98800', 'city': 'Noumea', 'country': 'New Caledonia', 'facility': 'Agence Sanitaire et Sociale Nouvelle Calédonie', 'geoPoint': {'lat': -22.27407, 'lon': 166.44884}}]}, 'ipdSharingStatementModule': {'url': 'http://data.gouv.nc/pages/accueil/?flg=fr', 'infoTypes': ['SAP'], 'timeFrame': 'within 1 year after the study end', 'ipdSharing': 'YES', 'description': 'Data will be share in new caledonia open data website. Data will be cleaned and anonymized prior sharing in on the open data', 'accessCriteria': 'Open access'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Agence Sanitaire et Sociale de Nouvelle Calédonie', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Institut Pasteur', 'class': 'INDUSTRY'}, {'name': 'Pacific Community', 'class': 'OTHER'}, {'name': 'World Health Organization', 'class': 'OTHER'}, {'name': 'Institut de la Statitique et des Etudes Economiques Nouvelle Calédonie', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}