Health Literacy LevelNCT06231667
The Effect of Health Literacy Education
A study testing Education in people with Health Literacy Level, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
The study was conducted with a parallel group randomized controlled experimental design to evaluate the effect of health literacy education given in early adolescence on the health literacy of adolescents. Read more about this study
- Who is it for?
- Ages 12 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Literacy Level
- What is being tested?
- Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2022to 30 Jan 2023
- 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 12 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Consent by the student's family
- Volunteering to participate in the research
- Having a low level of health literacy
Who cannot join
- Read and write Turkish
- Have a moderate or high level of health literacy
- Physical/mental disability or illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Health Literacy Education Given in Early Adolescence on Adolescents' Health Literacy
The study was conducted with a parallel group randomized controlled experimental design to evaluate the effect of health literacy education given in early adolescence on the health literacy of adolescents. The population of the study consisted of 6th and 7th grade (12-13 years old) students studying in a secondary school in Ankara. Power analysis was used to determine the sample size. A total of 80 adolescents who met the inclusion criteria were included in the sample.
- Conditions
- Health Literacy Level
- Being tested
- Education
- Keywords
- health literacy, education, adolescent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationOther
four training sessions were applied to the intervention group
| Study group | Role | What they receive |
|---|---|---|
| Education | Experimental | The health literacy training was implemented in a total of 4 sessions, each session lasting 30 minutes, with an interval of one week. Various teaching methods and techniques were used in the trainings. Receives: Other: Education |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Literacy Level (School Age Children Health Literacy Scale)
Health literacy level was evaluated in three groups: low health literacy (10-25 points), moderate health literacy (26-35 points) and (36-40) points: high health literacy (36-40 points). Intervention and control groups were selected among the students with low health literacy levels.
Measured: before the implementation
Health Literacy Level (School Age Children Health Literacy Scale)
Health literacy level was evaluated in three groups: low health literacy (10-25 points), moderate health literacy (26-35 points) and (36-40) points: high health literacy (36-40 points). Intervention and control groups were selected among the students with low health literacy levels.
Measured: one month after the education
Health Literacy Level (School Age Children Health Literacy Scale)
Health literacy level was evaluated in three groups: low health literacy (10-25 points), moderate health literacy (26-35 points) and (36-40) points: high health literacy (36-40 points). Intervention and control groups were selected among the students with low health literacy levels.
Measured: three month after the education
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start1 Sep 2022
- Primary completion15 Jan 2023
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Literacy LevelStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sultan Ayaz Alkaya, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06231667
- Sponsor's protocol ID
- 2022/07.03.2022
- Status last verified
- Jan 2024
- First submitted
- 18 Jan 2024
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Health Literacy Education Given in Early Adolescence on Adolescents' Health Literacy
- ClinicalTrials.gov ID
- NCT06231667
- Acronym / sponsor ID
- 2022/07.03.2022
- Conditions
- Health Literacy Level
- Keywords
- health literacy, education, adolescent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 15 Jan 2023 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 30 Jan 2024 (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.
The study was conducted with a parallel group randomized controlled experimental design to evaluate the effect of health literacy education given in early adolescence on the health literacy of adolescents. The population of the study consisted of 6th and 7th grade (12-13 years old) students studying in a secondary school in Ankara. Power analysis was used to determine the sample size. A total of 80 adolescents who met the inclusion criteria were included in the sample.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education | Experimental | Other: EducationThe health literacy training was implemented in a total of 4 sessions, each session lasting 30 minutes, with an interval of one week. Various teaching methods and techniques were used in the trainings. |
| Control | No intervention | – |
Who may qualify
- Ages
- 12 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Consent by the student's family
- Volunteering to participate in the research
- Having a low level of health literacy
Key exclusion criteria (3 listed)
- Read and write Turkish
- Have a moderate or high level of health literacy
- Physical/mental disability or illness
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 |
|---|---|---|
| Educationfour training sessions were applied to the intervention group | Other | Education |
Primary outcome
Health Literacy Level (School Age Children Health Literacy Scale)
Time frame: before the implementation
Health literacy level was evaluated in three groups: low health literacy (10-25 points), moderate health literacy (26-35 points) and (36-40) points: high health literacy (36-40 points). Intervention and control groups were selected among the students with low health literacy levels.
Health Literacy Level (School Age Children Health Literacy Scale)
Time frame: one month after the education
Health literacy level was evaluated in three groups: low health literacy (10-25 points), moderate health literacy (26-35 points) and (36-40) points: high health literacy (36-40 points). Intervention and control groups were selected among the students with low health literacy levels.
Health Literacy Level (School Age Children Health Literacy Scale)
Time frame: three month after the education
Health literacy level was evaluated in three groups: low health literacy (10-25 points), moderate health literacy (26-35 points) and (36-40) points: high health literacy (36-40 points). Intervention and control groups were selected among the students with low health literacy levels.
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 30 Jan 2024.
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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 Education in people with Health Literacy Level, run by Gazi University at 1 site in Turkey (Türkiye).
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 3 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 30 Jan 2024. 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 Turkey (Türkiye). 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?
Health Literacy Level (School Age Children Health Literacy Scale) (time frame: before the implementation). The study lists 3 primary outcomes in all. 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 30 Jan 2024.