HypertensionNCT04554017
Knowledge on Preventive Measures of Hypertension
A study testing Education/Training in people with Hypertension, run by Garden City University College at 1 site in Ghana.
Trial summary
Hypertension among children and adolescents is on the rise in both developed and developing countries. Childhood and adolescent obesity, a key factor for hypertension in this population results largely from unhealthy dietary and physical inactivity behaviours. Read more about this study
- Who is it for?
- Ages 13 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Education/Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 345 participants
- Where
- 1 siteGhana
- Study dates
- 15 Mar 2020to 22 Mar 2020
- 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 13 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Participants who gave consent
- Minors with parental or guardian assent
Who cannot join
- Participants already living with hypertension
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Knowledge on Preventive Measures of Hypertension: An Interventional Study Among Senior High School Students, Kenyase - Ghana
Hypertension among children and adolescents is on the rise in both developed and developing countries. Childhood and adolescent obesity, a key factor for hypertension in this population results largely from unhealthy dietary and physical inactivity behaviours. Adequate knowledge, a component for behavior change, has been found to be crucial to improving one's confidence to tackle these improper behaviours. Despite this, there are gaps in knowledge on hypertension and its risks factors in Ghanaian adolescents. Using an educational intervention (health talk), the study therefore sought to improve knowledge on preventive measures of hypertension among senior high school students in Ghana.
Read the detailed description
A pre-post interventional study using health talks was carried out among 345 adolescents aged 13 to 20 years. Participants included both male and female students aged 13 to 20 years. Owing to the large number, the students were divided into two groups. The Pre-test was then administered. Following this, two health education sessions were delivered by two registered nurses for each session. A week after these health talks, the research team went back to the school to collect data for the post-intervention. Questionnaires used for both pre and post assessment collected data on demographic factors and knowledge on dietary and physical activity behaviours linked to hypertension.
- Conditions
- Hypertension
- Being tested
- Education/Training
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education/TrainingOther
It consisted of a brief overview of hypertension, risk factors, complications and much emphasis placed on the preventive measures (what they include and why it is necessary to practice them).
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm - All participant (Single arm) | Experimental | Participants received education or health talks on dietary and physical activity behaviours linked to hypertension Receives: Other: Education/Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in participants knowledge on the preventives measures of hypertension using the mean scores
Close ended questionnaire was used to assess participants' knowledge on dietary practices and physical activity related to prevention of hypertension. The same questions were administered both pre- and post-assessment
Measured: 1 week
Secondary outcomes (1)
Association between the demographic characteristics and impact of the educational intervention on adolescents' knowledge on the preventive measures was measured using logistic regression analysis
In order to determine the association between the demographic characteristics and the impact of education on student's knowledge, the mean change in knowledge was categorize into two: <50% impact and ≥50%. Significance was set at p-value < 0.05.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start15 Mar 2020
- Primary completion22 Mar 2020
- Study completion22 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 345 participants (actual)
Sponsor and investigators
- Lead sponsor
- Garden City University College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isaac Nkrumah, Garden City University College
- Investigators
- Isaac Nkrumah, Masters, Principal investigator, Garden City University College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04554017
- Sponsor's protocol ID
- DOS/VOL.2/01/2020/01
- Status last verified
- Sep 2020
- First submitted
- 4 Sep 2020
- Last updated
- 18 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be made availability online immediately the paper is published in a journal. This will however, be before 12 months following study completion
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Knowledge on Preventive Measures of Hypertension: An Interventional Study Among Senior High School Students, Kenyase - Ghana
- ClinicalTrials.gov ID
- NCT04554017
- Acronym / sponsor ID
- DOS/VOL.2/01/2020/01
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 345 participants (actual)
- Lead sponsor
- Garden City University CollegeUniversity, hospital or other
- Study start
- 15 Mar 2020 (actual)
- Primary completion
- 22 Mar 2020 (actual)
- Study completion
- 22 Mar 2020 (actual)
- First posted
- 18 Sep 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.
Hypertension among children and adolescents is on the rise in both developed and developing countries. Childhood and adolescent obesity, a key factor for hypertension in this population results largely from unhealthy dietary and physical inactivity behaviours. Adequate knowledge, a component for behavior change, has been found to be crucial to improving one's confidence to tackle these improper behaviours. Despite this, there are gaps in knowledge on hypertension and its risks factors in Ghanaian adolescents. Using an educational intervention (health talk), the study therefore sought to improve knowledge on preventive measures of hypertension among senior high school students in Ghana.
Detailed description
A pre-post interventional study using health talks was carried out among 345 adolescents aged 13 to 20 years. Participants included both male and female students aged 13 to 20 years. Owing to the large number, the students were divided into two groups. The Pre-test was then administered. Following this, two health education sessions were delivered by two registered nurses for each session. A week after these health talks, the research team went back to the school to collect data for the post-intervention. Questionnaires used for both pre and post assessment collected data on demographic factors and knowledge on dietary and physical activity behaviours linked to hypertension.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention arm - All participant (Single arm) | Experimental | Other: Education/TrainingParticipants received education or health talks on dietary and physical activity behaviours linked to hypertension |
Who may qualify
- Ages
- 13 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Participants who gave consent
- Minors with parental or guardian assent
Key exclusion criteria (1 listed)
- Participants already living with hypertension
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 |
|---|---|---|
| Education/TrainingIt consisted of a brief overview of hypertension, risk factors, complications and much emphasis placed on the preventive measures (what they include and why it is necessary to practice them). | Other | Intervention arm - All participant (Single arm) |
Primary outcome
Change in participants knowledge on the preventives measures of hypertension using the mean scores
Time frame: 1 week
Close ended questionnaire was used to assess participants' knowledge on dietary practices and physical activity related to prevention of hypertension. The same questions were administered both pre- and post-assessment
1 secondary outcome
Association between the demographic characteristics and impact of the educational intervention on adolescents' knowledge on the preventive measures was measured using logistic regression analysis
Time frame: 1 week
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 18 Sep 2020.
- Individual participant dataSharing planned: Yes. IPD will be made availability online immediately the paper is published in a journal. This will however, be before 12 months following study completion
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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.
Isaac Nkrumah, Masters principal investigator
Garden City University College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education/Training in people with Hypertension, run by Garden City University College at 1 site in Ghana.
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 2 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 18 Sep 2020. 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 Ghana. 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?
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?
Change in participants knowledge on the preventives measures of hypertension using the mean scores (time frame: 1 week). 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 18 Sep 2020.