DiabetesNCT05218304
Baromètre Santé Adulte 2021-2022
A study testing Blood sample in people with Diabetes and Hypercholesterolemia, run by Agence Sanitaire et Sociale de Nouvelle Calédonie at 1 site in New Caledonia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Hypercholesterolemia, Renal Failure
- What is being tested?
- Blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,471 participants
- Where
- 1 siteNew Caledonia
- Study dates
- 26 Jul 2021to 30 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
New Caledonia1 site
Agence Sanitaire et Sociale Nouvelle Calédonie
Noumea, 98800
About this study
Official title: Baromètre Santé Adulte 2021-2022 in People Aged 18 to 64 in New Caledonia Using the WHO STEPwise Approach
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.
Read the 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.
- Conditions
- Diabetes, Hypercholesterolemia, Renal Failure, Dengue Fever, Zika, Chikungunya
- Being tested
- Blood sample
- Keywords
- Chronic disease, Diabetes, WHO STEP approach, Prevalence, New Caledonia
- Medical subject headings
- Diabetes Mellitus, Hypercholesterolemia, Renal Insufficiency, Dengue, Zika Virus Infection, Chikungunya Fever, Ross River Virus Infection, Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Biological: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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
Measured: Within a year after recruiting the participant
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.
Measured: Within a year after recruiting the participant
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.
Measured: Within a year after recruiting the participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start26 Jul 2021
- Primary completion30 Apr 2022 (estimated)
- Study completion30 May 2022 (estimated)
Why it stopped: Lockdown in the general population due to COVID
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is an observational, descriptive and cross-sectional study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 5,471 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Agence Sanitaire et Sociale de Nouvelle Calédonie
- Sponsor type
- Other government
- Collaborators
- Institut Pasteur, Pacific Community, World Health Organization, Institut de la Statitique et des Etudes Economiques Nouvelle Calédonie
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05218304
- Sponsor's protocol ID
- 2021-A01260-41
- Status last verified
- Jan 2022
- First submitted
- 18 Jan 2022
- Last updated
- 1 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be share in new caledonia open data website. Data will be cleaned and anonymized prior sharing in on the open data
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baromètre Santé Adulte 2021-2022 in People Aged 18 to 64 in New Caledonia Using the WHO STEPwise Approach
- ClinicalTrials.gov ID
- NCT05218304
- Acronym / sponsor ID
- 2021-A01260-41
- Conditions
- Diabetes, Hypercholesterolemia, Renal Failure, Dengue Fever, Zika, Chikungunya
- Keywords
- Chronic disease, Diabetes, WHO STEP approach, Prevalence, New Caledonia
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Lockdown in the general population due to COVID
- Enrolment
- 5,471 participants (estimated)
- Lead sponsor
- Agence Sanitaire et Sociale de Nouvelle CalédonieOther government
- Collaborators
- Institut Pasteur, Pacific Community, World Health Organization, Institut de la Statitique et des Etudes Economiques Nouvelle Calédonie
- Study start
- 26 Jul 2021 (actual)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 30 May 2022 (estimated)
- First posted
- 1 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is an observational, descriptive and cross-sectional study
| Arm | Type | Receives |
|---|---|---|
| Sample | No intervention | –questionnaires physical measurements (height, weight, perimeter abdominal and blood pressure) |
| Sub-sample - blood test | Experimental | Biological: Blood samplequestionnaires physical measurements (height, weight, perimeter abdominal and blood pressure) Blood samples |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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;
Key exclusion criteria (5 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampleA 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 | Biological | Sub-sample - blood test |
Primary outcome
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.
Time frame: Within a year after recruiting the participant
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.
3 secondary outcomes
Health behaviors of the target population using the first step of the WHO STEPS survey method.
Time frame: Within a year after recruiting the participant
To calculate the cardiovascular risk of the New Caledonian population using the SCORE projet
Time frame: Within a year after recruiting the participant
Seroprevalence of infectious diseases
Time frame: Within a year after recruiting the participant
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
- Individual participant dataSharing planned: Yes. Data will be share in new caledonia open data website. Data will be cleaned and anonymized prior sharing in on the open data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample in people with Diabetes and Hypercholesterolemia, run by Agence Sanitaire et Sociale de Nouvelle Calédonie at 1 site in New Caledonia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 1 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Caledonia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Within a year after recruiting the participant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2022.