Cardiovascular Risk FactorNCT04315441
Surveillance of Cardiovascular Risk Factors in Cameroonian Garrison
An observational study of Cardiovascular Risk Factor, run by Support and Education Technic Centre.
Trial summary
Purpose: The objective of our study was to assess the cardiovascular risk of a Cameroonian military population and compare it to the cardiovascular risk of the neighboring civilian population. Read more about this study
- Who is it for?
- Ages 18 to 58 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factor
- What is being tested?
- STEPS and AUDIT questionnaires
- How many people
- 566 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 13 Nov 2018
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 58 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The subjects of our study were recruited according to two methods at the Military Medical Center of Sector N°5 in Ngaoundere. Participation in the study was proposed to any soldier who attended the Military Medical Center of Sector N°5 for the annual re-engagement medical visit during the period from January 1, 2017 to November 13, 2018. The civilian populations were recruited from two free cardiovascular risk factors screening campaigns carried out from January 04, 2017 to January 10, 2017 and from November 12, 2018 to November 18, 2018. These campaigns were open to soldiers wishing to participate.
Who may be able to join
- agree to participate,
- had to be aged between 18 and 58 years old,
- representing ages of enrollment and retirement for Cameroonian soldiers respectively.
Who cannot join
- -
About this study
Purpose: The objective of our study was to assess the cardiovascular risk of a Cameroonian military population and compare it to the cardiovascular risk of the neighboring civilian population.
Patients and methods: We will conduct a cross-sectional study that involved subjects aged from 18 to 58 years, recruited from October 2017 to November 2018 at the Fifth Military Sector Health Center in Ngaoundéré. Data collection and assessment was done according to World Health Organization STEPS manual for surveillance of risk factors of Non-communicable chronic diseases; and the Alcohol Use Disorders Identification Test. Five cardiovascular risk factors were assessed, smoking, harmful alcohol consumption, obesity/overweight, hypertension and diabetes. Cardiovascular risk was considered high in subjects with three or more cardiovascular risk factors. Univariates analysis and multivariate logistic regression were carried out according to their indications.
- Conditions
- Cardiovascular Risk Factor
- Being tested
- STEPS and AUDIT questionnaires
- Keywords
- prevention, non-communicable disease, cardiovascular diseases, cardiovascular risk, soldiers
- Medical subject headings
- Noncommunicable Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STEPS and AUDIT questionnairesDiagnostic test
assessment was done according to World Health Organization STEPS manual for surveillance of risk factors of Non-communicable chronic diseases; and the Alcohol Use Disorders Identification Test. Five cardiovascular risk factors were assessed, smoking, harmful alcohol consumption, obesity/overweight, hypertension and diabetes. Cardiovascular risk was considered high in subjects with three or more cardiovascular risk factors.
| Study group | Role | What they receive |
|---|---|---|
| Soldiers | any soldier who attended the Military Medical Center of Sector N°5 for the annual re-engagement medical visit during the period from January 1, 2017 to November 13, 2018. Receives: Diagnostic Test: STEPS and AUDIT questionnaires | |
| Civilians | The civilian populations were recruited from two free cardiovascular risk factors screening campaigns carried out from January 04, 2017 to January 10, 2017 and from November 12, 2018 to November 18, 2018 Receives: Diagnostic Test: STEPS and AUDIT questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular risk factor
evaluated by summing the participant's cardiovascular risk factors. The cardiovascular risk factors used for the cardiovascular risk assessment were smoking, excessive alcohol consumption (defined by an AUDIT score ≥ 8), overweight or obesity, hypertension, and diabetes. The cardiovascular risk was considered high if the subject had a combination of at least 3 cardiovascular risk factors.
Measured: At inclusion
Secondary outcomes (6)
Smoking
answering "yes" to the question do you smoke?
Measured: At inclusion
Alcoholism
answering "yes" to the question do you consume alcohol?
Measured: At inclusion
Body mass index
3 modalities was defined according to BMI. Underweight (BMI < 18.5 Kg/m2), normal weight (18 ≤ BMI < 25 Kg/m²), overweight (25 ≤ BMI < 30 Kg/m²), obesity (BMI ≥ 30 Kg/m²).
Measured: At inclusion
Systolic Blood Pressure (mmHg)
Systolic blood pressure ≥ 140 mmHg or taking a hypotensive treatment.
Measured: At inclusion
Glycaemia (mmol/L)
Fasting blood glucose ≥ 7 mmol/l or taking a hypoglycemic treatment
Measured: At inclusion
Diastolic Blood Pressure (mmHg)
diastolic ≥ 90 mmHg or taking a hypotensive treatment.
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start1 Jan 2017
- Primary completion12 Nov 2018
- Study completion13 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Risk FactorStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 566 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Support and Education Technic Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bienvenu BONGUE, Support and Education Technic Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04315441
- Sponsor's protocol ID
- UJM_UDD_01
- Status last verified
- Mar 2020
- First submitted
- 12 Mar 2020
- Last updated
- 19 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bell Ngan W, Essama Eno Belinga L, Essam Nlo'o ASP, Roche F, Goethals L, Mandengue SH, Bongue B. Surveillance of Cardiovascular Risk Factors in the Fifth Military Sector Health Center, Ngaoundere, Cameroon: Observational Study. JMIR Form Res. 2020 Nov 26;4(11):e18567. doi: 10.2196/18567.
PubMed 33242013
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surveillance of Cardiovascular Risk Factors in Cameroonian Garrison
- ClinicalTrials.gov ID
- NCT04315441
- Acronym / sponsor ID
- UJM_UDD_01
- Conditions
- Cardiovascular Risk Factor
- Keywords
- prevention, non-communicable disease, cardiovascular diseases, cardiovascular risk, soldiers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 566 participants (actual)
- Lead sponsor
- Support and Education Technic CentreUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 12 Nov 2018 (actual)
- Study completion
- 13 Nov 2018 (actual)
- First posted
- 19 Mar 2020 (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.
Purpose: The objective of our study was to assess the cardiovascular risk of a Cameroonian military population and compare it to the cardiovascular risk of the neighboring civilian population.
Patients and methods: We will conduct a cross-sectional study that involved subjects aged from 18 to 58 years, recruited from October 2017 to November 2018 at the Fifth Military Sector Health Center in Ngaoundéré. Data collection and assessment was done according to World Health Organization STEPS manual for surveillance of risk factors of Non-communicable chronic diseases; and the Alcohol Use Disorders Identification Test. Five cardiovascular risk factors were assessed, smoking, harmful alcohol consumption, obesity/overweight, hypertension and diabetes. Cardiovascular risk was considered high in subjects with three or more cardiovascular risk factors. Univariates analysis and multivariate logistic regression were carried out according to their indications.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Soldiers | – | Diagnostic Test: STEPS and AUDIT questionnairesany soldier who attended the Military Medical Center of Sector N°5 for the annual re-engagement medical visit during the period from January 1, 2017 to November 13, 2018. |
| Civilians | – | Diagnostic Test: STEPS and AUDIT questionnairesThe civilian populations were recruited from two free cardiovascular risk factors screening campaigns carried out from January 04, 2017 to January 10, 2017 and from November 12, 2018 to November 18, 2018 |
Who may qualify
- Ages
- 18 to 58 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The subjects of our study were recruited according to two methods at the Military Medical Center of Sector N°5 in Ngaoundere. Participation in the study was proposed to any soldier who attended the Military Medical Center of Sector N°5 for the annual re-engagement medical visit during the period from January 1, 2017 to November 13, 2018. The civilian populations were recruited from two free cardiovascular risk factors screening campaigns carried out from January 04, 2017 to January 10, 2017 and from November 12, 2018 to November 18, 2018. These campaigns were open to soldiers wishing to participate.
Key inclusion criteria (3 listed)
- agree to participate,
- had to be aged between 18 and 58 years old,
- representing ages of enrollment and retirement for Cameroonian soldiers respectively.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| STEPS and AUDIT questionnairesassessment was done according to World Health Organization STEPS manual for surveillance of risk factors of Non-communicable chronic diseases; and the Alcohol Use Disorders Identification Test. Five cardiovascular risk factors were assessed, smoking, harmful alcohol consumption, obesity/overweight, hypertension and diabetes. Cardiovascular risk was considered high in subjects with three or more cardiovascular risk factors. | Diagnostic test | Civilians, Soldiers |
Primary outcome
Cardiovascular risk factor
Time frame: At inclusion
evaluated by summing the participant's cardiovascular risk factors. The cardiovascular risk factors used for the cardiovascular risk assessment were smoking, excessive alcohol consumption (defined by an AUDIT score ≥ 8), overweight or obesity, hypertension, and diabetes. The cardiovascular risk was considered high if the subject had a combination of at least 3 cardiovascular risk factors.
6 secondary outcomes
Smoking
Time frame: At inclusion
Alcoholism
Time frame: At inclusion
Body mass index
Time frame: At inclusion
Systolic Blood Pressure (mmHg)
Time frame: At inclusion
Glycaemia (mmol/L)
Time frame: At inclusion
Diastolic Blood Pressure (mmHg)
Time frame: At inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2020.
- Derived from this study: PubMed 33242013Bell Ngan W, Essama Eno Belinga L, Essam Nlo'o ASP, Roche F, Goethals L, Mandengue SH, Bongue B. Surveillance of Cardiovascular Risk Factors in the Fifth Military Sector Health Center, Ngaoundere, Cameroon: Observational Study. JMIR Form Res. 2020 Nov 26;4(11):e18567. doi: 10.2196/18567.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Risk Factor, run by Support and Education Technic Centre.
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 1 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: finished, as of the sponsor's last update on 19 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cardiovascular risk factor (time frame: At inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04315441, which also lists 1 linked publication.
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 19 Mar 2020.