Health LiteracyNCT07320079
Evaluation of the Effectiveness of Health Literacy Education Given to Women by Teach-Back Method
A study testing teach-back in people with Health Literacy and Teach Back, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
This study aims to enhance women's health literacy levels and to examine the effectiveness of the teach-back teaching technique in improving women's health literacy. The research was designed as a randomized controlled study. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Health Literacy, Teach Back
- What is being tested?
- teach-back
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Mar 2026to 20 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women aged between 18 and 65 years
- Those with a General Health Questionnaire-12 score below 4
Who cannot join
- Illiterate women
- Male individuals
- Those with communication difficulties
- Healthcare professionals (physicians, midwives, nurses, etc.)
- Emergency patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul University- Cerrahpasa
Istanbul, 34500
About this study
Official title: Evaluation of the Effectiveness of Health Literacy Education Given to Women by Teach-Back Method: Randomized Controlled Trial
This study aims to enhance women's health literacy levels and to examine the effectiveness of the teach-back teaching technique in improving women's health literacy. The research was designed as a randomized controlled study. In addition, this study aims to answer the question of whether health literacy education delivered using the teach-back method is effective in improving women's health literacy levels. Within the scope of the study, participants in the experimental group will receive health literacy education using the teach-back technique, while the control group will receive standard care. Data will be collected using a questionnaire method.
Read the detailed description
This study aims to enhance women's health literacy levels and to examine the effectiveness of the teach-back teaching technique in improving women's health literacy. Women aged between 18 and 65 years with a General Health Questionnaire-12 score below 4 will be included in the study. To determine the participants' socio-demographic and health characteristics, the "Personal Information Form" will be used; to assess general health, the "General Health Questionnaire-12" will be applied; to measure health literacy levels, the "Türkiye Health Literacy Scale-32 (TSOY-32)" will be utilized; and to assess self-efficacy, the "General Self-Efficacy Scale" will be employed. Additionally, the "Training Effectiveness Evaluation Form" will be used to evaluate the effectiveness of the education provided to the experimental group. The study will consist of a total of 74 participants, with 37 in the experimental group and 37 in the control group. Verbal and written consent will be obtained from participants who agree to take part in the study, and the participants will be assigned to groups accordingly. The experimental group will receive face-to-face health literacy education using the teach-back method in six sessions, each lasting 45 minutes per week. The control group will receive standard care.
- Conditions
- Health Literacy, Teach Back
- Being tested
- teach-back, Control Group
- Keywords
- Health literacy, Teach-back, Women, Self-efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
teach-backOther
The experimental group will receive face-to-face health literacy education using the teach-back method in six sessions, each lasting 45 minutes per week.
The training will be provided by the researcher on a one-to-one basis. Health literacy education will be delivered using the teach-back method. After each session, participants will be asked to repeat what they have learned in their own words. The researcher will assess how well the participants have understood the topic. Any misunderstandings will be identified and corrected. During this process, participants will also have the opportunity to ask questions. Additional information will be provided if necessary until participants can accurately repeat the expected knowledge. The module will be considered complete once the participants have correctly expressed the information and understood the topic. The following week, the next module will begin, and this process will continue until all six modules are completed.
Control GroupOther
The control group will receive standard care
| Study group | Role | What they receive |
|---|---|---|
| Teach-back | Experimental | The experimental group will receive face-to-face health literacy education using the teach-back method in six sessions, each lasting 45 minutes per week.
The training will be provided by the researcher on a one-to-one basis. Health literacy education will be delivered using the teach-back method. After each session, participants will be asked to repeat what they have learned in their own words. The researcher will assess how well the participants have understood the topic. Any misunderstandings will be identified and corrected. During this process, participants will also have the opportunity to ask questions. Additional information will be provided if necessary until participants can accurately repeat the expected knowledge. The module will be considered complete once the participants have correctly expressed the information and understood the topic. The following week, the next module will begin, and this process will continue until all six modules are completed. Receives: Other: teach-back |
| Control Group | Other | The control group will receive standard care. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health literacy
The Turkey Health Literacy Scale-32 will be used to measure health literacy levels. It is a scale consisting of 32 questions. The total score takes values between 0 and 50. 0 indicates the lowest health literacy level, and 50 indicates the highest health literacy level.
According to the scoring system below, health literacy is defined as follows:
a score of 0-25 indicates inadequate health literacy; a score of >25-33 indicates problematic-limited health literacy; a score of >33-42 indicates adequate health literacy; and a score of >42-50 indicates excellent health literacy.
Measured: Measurements will be taken at baseline, immediately after the training (week 6), and one month after the training (week 10).
The General Self-Efficacy Scale
The General Self-Efficacy Scale will be used to measure the participants' self-efficacy levels. The scale is a 5-point Likert-type instrument consisting of three subdimensions and 17 items. The subdimensions are Initiation (9 items), Persistence (5 items), and Maintenance Effort-Determination (3 items). The total scale score ranges from 17 to 85, with higher total scores indicating a higher level of self-efficacy belief.
Measured: Measurements will be taken at baseline, immediately after the training (week 6), and one month after the training (week 10).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start2 Mar 2026
- Primary completion1 Feb 2027 (estimated)
- Study completion20 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health LiteracyStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental group and control group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Dünmez, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07320079
- Sponsor's protocol ID
- 2025-708
- Status last verified
- Aug 2026
- First submitted
- 22 Dec 2025
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Health Literacy Education Given to Women by Teach-Back Method: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07320079
- Acronym / sponsor ID
- 2025-708
- Conditions
- Health Literacy, Teach Back
- Keywords
- Health literacy, Teach-back, Women, Self-efficacy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 2 Mar 2026 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 20 Jul 2027 (estimated)
- First posted
- 6 Jan 2026 (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.
This study aims to enhance women's health literacy levels and to examine the effectiveness of the teach-back teaching technique in improving women's health literacy. The research was designed as a randomized controlled study. In addition, this study aims to answer the question of whether health literacy education delivered using the teach-back method is effective in improving women's health literacy levels. Within the scope of the study, participants in the experimental group will receive health literacy education using the teach-back technique, while the control group will receive standard care. Data will be collected using a questionnaire method.
Detailed description
This study aims to enhance women's health literacy levels and to examine the effectiveness of the teach-back teaching technique in improving women's health literacy. Women aged between 18 and 65 years with a General Health Questionnaire-12 score below 4 will be included in the study. To determine the participants' socio-demographic and health characteristics, the "Personal Information Form" will be used; to assess general health, the "General Health Questionnaire-12" will be applied; to measure health literacy levels, the "Türkiye Health Literacy Scale-32 (TSOY-32)" will be utilized; and to assess self-efficacy, the "General Self-Efficacy Scale" will be employed. Additionally, the "Training Effectiveness Evaluation Form" will be used to evaluate the effectiveness of the education provided to the experimental group. The study will consist of a total of 74 participants, with 37 in the experimental group and 37 in the control group. Verbal and written consent will be obtained from participants who agree to take part in the study, and the participants will be assigned to groups accordingly. The experimental group will receive face-to-face health literacy education using the teach-back method in six sessions, each lasting 45 minutes per week. The control group will receive standard care.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Experimental group and control group
| Arm | Type | Receives |
|---|---|---|
| Teach-back | Experimental | Other: teach-backThe experimental group will receive face-to-face health literacy education using the teach-back method in six sessions, each lasting 45 minutes per week. The training will be provided by the researcher on a one-to-one basis. Health literacy education will be delivered using the teach-back method. After each session, participants will be asked to repeat what they have learned in their own words. The researcher will assess how well the participants have understood the topic. Any misunderstandings will be identified and corrected. During this process, participants will also have the opportunity to ask questions. Additional information will be provided if necessary until participants can accurately repeat the expected knowledge. The module will be considered complete once the participants have correctly expressed the information and understood the topic. The following week, the next module will begin, and this process will continue until all six modules are completed. |
| Control Group | Other | Other: Control GroupThe control group will receive standard care. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women aged between 18 and 65 years
- Those with a General Health Questionnaire-12 score below 4
Key exclusion criteria (5 listed)
- Illiterate women
- Male individuals
- Those with communication difficulties
- Healthcare professionals (physicians, midwives, nurses, etc.)
- Emergency patients
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 |
|---|---|---|
| teach-backThe experimental group will receive face-to-face health literacy education using the teach-back method in six sessions, each lasting 45 minutes per week. The training will be provided by the researcher on a one-to-one basis. Health literacy education will be delivered using the teach-back method. After each session, participants will be asked to repeat what they have learned in their own words. The researcher will assess how well the participants have understood the topic. Any misunderstandings will be identified and corrected. During this process, participants will also have the opportunity to ask questions. Additional information will be provided if necessary until participants can accurately repeat the expected knowledge. The module will be considered complete once the participants have correctly expressed the information and understood the topic. The following week, the next module will begin, and this process will continue until all six modules are completed. | Other | Teach-back |
| Control GroupThe control group will receive standard care | Other | Control Group |
Primary outcome
Health literacy
Time frame: Measurements will be taken at baseline, immediately after the training (week 6), and one month after the training (week 10).
The Turkey Health Literacy Scale-32 will be used to measure health literacy levels. It is a scale consisting of 32 questions. The total score takes values between 0 and 50. 0 indicates the lowest health literacy level, and 50 indicates the highest health literacy level. According to the scoring system below, health literacy is defined as follows: a score of 0-25 indicates inadequate health literacy; a score of >25-33 indicates problematic-limited health literacy; a score of >33-42 indicates adequate health literacy; and a score of >42-50 indicates excellent health literacy.
The General Self-Efficacy Scale
Time frame: Measurements will be taken at baseline, immediately after the training (week 6), and one month after the training (week 10).
The General Self-Efficacy Scale will be used to measure the participants' self-efficacy levels. The scale is a 5-point Likert-type instrument consisting of three subdimensions and 17 items. The subdimensions are Initiation (9 items), Persistence (5 items), and Maintenance Effort-Determination (3 items). The total scale score ranges from 17 to 85, with higher total scores indicating a higher level of self-efficacy belief.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing teach-back in people with Health Literacy and Teach Back, run by Istanbul University - Cerrahpasa 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 2 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: looking for participants now, as of the sponsor's last update on 14 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fatma PhD student (+90 (212) 866 37 00, fatmadunmezz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health literacy (time frame: Measurements will be taken at baseline, immediately after the training (week 6), and one month after the training (week 10).). The study lists 2 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 14 Aug 2026.