Health PromotionNCT07306520
Effects of the Health Promotion Program on Health Literacy, Physical and Mental Health Status, and Quality of Life
A study testing Health education, Auricular acupressure and Exercise in people with Health Promotion, run by Inha University Hospital at 1 site in South Korea.
Trial summary
This study aims to evaluate the physical and mental health status, prevalence of chronic diseases, health literacy, and health behaviors of residents in Gandaki Province, Nepal, and to assess the effectiveness of a community-based health promotion program integrating health education, exercise, and auricular… Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Promotion
- What is being tested?
- Health education, Auricular acupressure and Exercise
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Dec 2024to 31 Mar 2031
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- people who
- aged 19 and older
- are able to read and respond to the questionnaire
- people who
- aged 19 and older
- who are able to read and respond to the questionnaire
Show all 9Show fewer
- adults ls who reported a pain score of 3 or higher on the Numeric Rating Scale for symptoms (NRS) will be asked about their willingness to participate.
- Residents aged 19 and older who are able to read and respond to the questionnaire will be recruited for health screenings and surveys.
- Exclusion criteria: Individuals with medical conditions that contraindicate participation in exercise
Who cannot join
- people who are not able to read and respond to the questionnaire
- [Health Education]
- people who are not able to read and respond to the questionnaire
- [Auricular Acupressure]
- those who are pregnant
- those with a metal allergy
- those with ear-related disorders.
- [Exercise]
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of the Health Promotion Program on Health Literacy, Physical and Mental Health Status, and Quality of Life of Community Residents in Selected Districts of Gandaki Province, Nepal
This study aims to evaluate the physical and mental health status, prevalence of chronic diseases, health literacy, and health behaviors of residents in Gandaki Province, Nepal, and to assess the effectiveness of a community-based health promotion program integrating health education, exercise, and auricular acupressure. The intervention is designed to improve quality of life, health literacy, and chronic disease management among rural populations with limited healthcare access.
This is a prospective interventional cohort study conducted over seven years (2025-2031) in two rural villages of Pokhara, Gandaki Province: Belchautara (experimental) and Rupakot (control). A total of 400 residents aged 19 years and older will be screened and enrolled (200 per village). Participants will be recruited through local nursing colleges and health centers.
Read more
Year 1 involves mixed methods research (descriptive-correlational and qualitative) to identify community health needs.
Years 2-7 will employ a quasi-experimental design with annual interventions and follow-up evaluations.
Interventions
- Health Education Program: Frequency: 12 weekly sessions (1 hour each), repeated three times per year. Content: hygiene, nutrition, stress management, lifestyle modification. Measures: health literacy, blood pressure, glucose, cholesterol, anthropometry, quality of life, and PHQ-9.
- Exercise Program: Frequency: 8 weekly sessions (1 hour each), repeated three times per year. Activities: muscle stretching, sit-ups, push-ups, sit-to-stand, and grip strength training. Measures: Sit and Reach Test, push-up and sit-up counts, grip strength.
- Auricular Acupressure:
Indications: back pain, dysmenorrhea, or perimenopausal symptoms. Frequency: once per week for 2 weeks. Measures: Numeric Rating Scale (NRS), Oswestry Disability Index, Menstrual Distress Questionnaire, and Perimenopause Symptom Scale.
Exclusion: pregnancy, metal allergy, or ear disease.
Data will be collected at baseline and post-intervention through structured questionnaires and physical measurements.
- Conditions
- Health Promotion
- Being tested
- Health education, Auricular acupressure, Exercise
- Keywords
- physical health, mental health, chronic disease, quality of life, health literacy, health behavior, health education program, exercise, auricular acupressure, Cohort, health promotion program, Quasi-experimental study, Nepal
- Medical subject headings
- Psychological Well-Being, Chronic Disease, Health Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health educationBehavioural
Frequency: 12 sessions, once per week, one hour Will repeat three times a year.
Auricular acupressureDevice
Frequency: 2 sessions, once per week for 2 weeks
ExerciseBehavioural
Frequency: 8 sessions, once per week, one hour Will repeat three times a year
| Study group | Role | What they receive |
|---|---|---|
| Health Education Group | Experimental | Obesity, DM, hypertension, cholesterol Receives: Behavioral: Health education |
| Health Education Control Group | No intervention | Obesity, DM, hypertension, cholesterol |
| Auricular Acupressure Group1 | Experimental | Back pain Receives: Device: Auricular acupressure |
| Auricular Acupressure Control Group1 | No intervention | Back pain |
| Auricular Acupressure Group2 | Experimental | Dysmenorrhea Receives: Device: Auricular acupressure |
| Auricular Acupressure Control Group2 | No intervention | Dysmenorrhea |
| Auricular Acupressure Group3 | Experimental | Perimenopausal symptoms Receives: Device: Auricular acupressure |
| Auricular Acupressure Control Group3 | No intervention | Perimenopausal symptoms |
| Exercise Group | Experimental | Obesity, DM, hypertension, cholesterol Receives: Behavioral: Exercise |
| Exercise Control Group | No intervention | Obesity, DM, hypertension, cholesterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Literacy (HLS-EU-Q47)
Health literacy will be assessed using the HLS-EU-Q47 (European Health Literacy Survey) developed by the World Health Organization (WHO) European Office. The tool will be used with permission after being translated and adapted by Chun Hee-Ran and Lee Ju-Yeol. It consists of 16 items, including 7 on healthcare, 5 on disease prevention, and 4 on health promotion, measured on a 4-point scale (very difficult to very easy). Responses of difficult/very difficult are scored as 0, while easy/very easy are scored as 1. Higher scores indicate greater health literacy (range 1-16). Based on total scores, 0-8 points indicate inadequate, 9-12 points indicate borderline, and 13 points or higher indicate sufficient health lieteracy.
Measured: baseline, 12 weeks
Subjective Perception of Health (5-point Likert scale)
Subjective perception of health refers to an individual's self-assessment of their health status, whether good or poor. This is evaluated on a 5-point Likert scale with the responses: ① Very good, ② Good, ③ Fair, ④ Poor, and ⑤ Very poor. The subjective change in health status is a self-assessment of whether one's health has improved or worsened compared to a previous assessment. The question is: "How is your current health compared to the previous baseline survey?" Responses are measured on a 5-point Likert scale: ① Very much improved, ② Somewhat improved, ③ Same as before, ④ Somewhat worsened, and ⑤ Very much worsened (16).
Measured: baseline, 12 weeks
Mental Health (Patient Health Questionnaire (PHQ-9))
The PHQ-9 (Patient Health Questionnaire) will assess the Mental Health. The PHQ-9 is a tool developed for diagnosing major depressive disorder and is widely used in primary healthcare settings. Participants are asked how often they experienced problems over the past two weeks, measured on a 4-point scale (Not at all to Nearly every day), with scores ranging from 0-27. Higher scores indicate more severe depressive symptoms. When using a cutoff score of 10, the sensitivity (94%) and specificity (80%) are high. Cronbach's alpha was reported as 0.84 among 125 Nepali primary care patients.
Measured: baseline, 12 weeks
Quality of life (EQ-5D-5L Score)
Quality of life will be measured using the EQ-5D-5L, developed and translated in Nepalese by EuroQol. The EQ-5D-5L assesses current health status across five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each domain is rated on a 5-point scale from no problems to extreme problems. Reliability (ICC = 0.75). and one factor explained 88.3% of total variance. The EuroQol group provides a Nepali version of the tool, which will be used with approval.
Measured: baseline, 12 weeks
Secondary outcomes (10)
Numeric Rating Scale for Symptoms (NRS)
The Numeric Rating Scale for symptoms (NRS) is widely used in clinical practice due to its simplicity and convenience for assessing pain and various symptoms. The NRS measures symptoms on a scale from 0 to 10, with scores closer to 10 indicating greater severity of perceived symptoms.
Measured: baseline, 12 weeks
Blood Pressure (automatic blood pressure cuff)
Blood pressure will be measured using an automatic blood pressure cuff. Both systolic and diastolic blood pressure will be measured. Participants will be asked to sit quietly for 2-3 minutes and remove any tight clothing. Measurements will be taken on both the right and left arms, ensuring that the mid-arm is positioned at heart level. Elevated blood pressure is defined as exceeding the 95th percentile for age and height.
Measured: baseline, 12 weeks
Fasting blood glucose level
To measure fasting capillary blood glucose, participants will be instructed to fast overnight after dinner. The next morning, their fingers will be disinfected with alcohol swabs, allowed to dry, and blood will be drawn from peripheral capillaries using a new lancet. Measurements will be taken using the Accu-Chek Active glucose meter and the SD CodeFree glucose meter.
Measured: baseline, 12 weeks
Fasting Cholesterol Level
To measure fasting cholesterol, participants will be instructed to fast overnight after dinner. The next morning, their fingers will be disinfected with alcohol swabs, allowed to dry, and blood will be drawn from peripheral capillaries using a new lancet. Measurements will be taken using the CardioCheck PA device.
Measured: baseline, 12 weeks
Effect of exercise (SIt-and-Reach Test Score)
The Sit-and-Reach Test will be used for the effect of exercise. This test is a simple, widely used method to assess overall flexibility, particularly of the lower back and hamstrings. It involves reaching forward while seated with legs straight, measuring the distance reached. Participants sit on the floor with their legs fully extended and feet placed against a standardized measurement box. With both hands overlapped and arms fully extended, participants reach forward as far as possible and hold the position for 2 seconds. The distance reached (in centimeters) is recorded as the Sit-and-Reach Test score, with higher values indicating greater flexibility.
Measured: baseline, 8 weeks
Effect of exercise (Grip Strength Test)
This test will be used for the effect of exercise. Grip strength test measures how much force a person can exert when squeezing a hand grip dynamometer. It's a simple and commonly used method for assessing general muscle strength, particularly in the forearm, and is often used in medical and fitness settings. Grip strength is measured using an electronic hand dynamometer. Participants hold the dynamometer in their both hands separately, with the arm in a neutral position alongside the body. They are instructed to squeeze the device with maximum effort for a few seconds. The highest value (in kilograms) from repeated trials is recorded as the final grip strength score.
Measured: baseline, 8 weeks
Effect of exercise (Push-up and Sit-up Test (1-Minute Test))
This test will be used for the effect of exercise. Muscular endurance is assessed by counting the number of push-ups and sit-ups performed within one minute. For push-ups, participants perform standard push-ups with proper posture. For sit-ups, participants lie in the supine position with knees bent and perform consecutive sit-ups for one minute. The total number of correctly completed repetitions within 60 seconds is recorded for each exercise.
Measured: baseline, 8 weeks
Dysmenorrhea (Menstrual Distress Questionnaire (MEDI-Q))
Dysmenorrhea will be measured using the Menstrual Distress Questionnaire (MEDI-Q). This tool developed by Silvia et al. 2021 assess 25 items, covering the following areas: pain, discomfort, psychic or cognitive changes, gastrointestinal symptoms and changes in physiological functions. The MEDI-Q Total Score is obtained from the sum of all the distress scores calculated for each item. The minimum score obtainable is 0, indicating the absence of any specified symptom relevant to generate distress during menstruation in the previous 12 months. The maximum score is 125, indicating the presence of all the investigated symptoms in more than one-half of menstruations in the past year, each of them generating severe distress. This tool has high internal consistency (Cronbach's alpha ≥0.95) and test-retest reliability (from 0.60 to 0.70).
Measured: baseline, 2 weeks
Perimenopause symptoms (Perimenopausal Symptoms Rating Scale (MRS scale))
Perimenopause symptoms will be measured using the Perimenopausal Symptoms Rating Scale. This tool will be used in this study which is a valuable tool for assessing health related quality of life of women in the menopausal transition and it is used worldwide. It is a standardized scale meeting psychometric norm. There are 11 questions and each symptom has five ordinal scales of rating menopausal symptoms by its severity. Severity is described into five levels as none (0), mild (1), moderate (2), severe (3) and very severe (4). For this study, the tool will be used with permission and applied in its validated Nepali version, which has been previously used in Nepal (Menopause Rating Scale: Validation and Applicability in Nepalese Women).
Measured: baseline, 2 weeks
Disability in daily life due to musculoskeletal pain (Oswestry Disability Index(ODI))
The level of disability in daily life due to musculoskeletal pain was measured using the Oswestry Disability Index. The ODI consists of 10 Items (pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sexual activity, social life, and traveling), with each item scored from 0 to 5. The total score is summed and then multiplied by 2 to convert it into a percentage. The levels of disability are interpreted as follows - 0-20%: Minimal disability (able to perform daily activities without special measures), 21-40%: Moderate disability (pain and difficulty present in daily life, requiring conservative treatment), 41-60%: Severe disability (persistent pain significantly interferes with daily life, requiring detailed examination), 61-80%: Crippling disability (affects all aspects of personal life, requiring active treatment), 81-100%: Bed-bound (unable to carry out daily activities)
Measured: baseline. 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start25 Dec 2024
- Primary completion31 Mar 2031 (estimated)
- Study completion31 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health PromotionStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- PRECEDE-PROCEED Model
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inha University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, EUN JIN LEE, Inha University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07306520
- Sponsor's protocol ID
- 241015-1A
- Status last verified
- Dec 2025
- First submitted
- 21 Nov 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Health Promotion Program on Health Literacy, Physical and Mental Health Status, and Quality of Life of Community Residents in Selected Districts of Gandaki Province, Nepal
- ClinicalTrials.gov ID
- NCT07306520
- Acronym / sponsor ID
- 241015-1A
- Conditions
- Health Promotion
- Keywords
- physical health, mental health, chronic disease, quality of life, health literacy, health behavior, health education program, exercise
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Inha University HospitalUniversity, hospital or other
- Study start
- 25 Dec 2024 (actual)
- Primary completion
- 31 Mar 2031 (estimated)
- Study completion
- 31 Mar 2031 (estimated)
- First posted
- 29 Dec 2025 (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 evaluate the physical and mental health status, prevalence of chronic diseases, health literacy, and health behaviors of residents in Gandaki Province, Nepal, and to assess the effectiveness of a community-based health promotion program integrating health education, exercise, and auricular acupressure. The intervention is designed to improve quality of life, health literacy, and chronic disease management among rural populations with limited healthcare access.
This is a prospective interventional cohort study conducted over seven years (2025-2031) in two rural villages of Pokhara, Gandaki Province: Belchautara (experimental) and Rupakot (control). A total of 400 residents aged 19 years and older will be screened and enrolled (200 per village). Participants will be recruited through local nursing colleges and health centers.
Year 1 involves mixed methods research (descriptive-correlational and qualitative) to identify community health needs.
Years 2-7 will employ a quasi-experimental design with annual interventions and follow-up evaluations.
Interventions
- Health Education Program: Frequency: 12 weekly sessions (1 hour each), repeated three times per year. Content: hygiene, nutrition, stress management, lifestyle modification. Measures: health literacy, blood pressure, glucose, cholesterol, anthropometry, quality of life, and PHQ-9.
- Exercise Program: Frequency: 8 weekly sessions (1 hour each), repeated three times per year. Activities: muscle stretching, sit-ups, push-ups, sit-to-stand, and grip strength training. Measures: Sit and Reach Test, push-up and sit-up counts, grip strength.
- Auricular Acupressure:
Indications: back pain, dysmenorrhea, or perimenopausal symptoms. Frequency: once per week for 2 weeks. Measures: Numeric Rating Scale (NRS), Oswestry Disability Index, Menstrual Distress Questionnaire, and Perimenopause Symptom Scale.
Exclusion: pregnancy, metal allergy, or ear disease.
Data will be collected at baseline and post-intervention through structured questionnaires and physical measurements.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 10
- Model description
- PRECEDE-PROCEED Model
| Arm | Type | Receives |
|---|---|---|
| Health Education Group | Experimental | Behavioral: Health educationObesity, DM, hypertension, cholesterol |
| Health Education Control Group | No intervention | –Obesity, DM, hypertension, cholesterol |
| Auricular Acupressure Group1 | Experimental | Device: Auricular acupressureBack pain |
| Auricular Acupressure Control Group1 | No intervention | –Back pain |
| Auricular Acupressure Group2 | Experimental | Device: Auricular acupressureDysmenorrhea |
| Auricular Acupressure Control Group2 | No intervention | –Dysmenorrhea |
| Auricular Acupressure Group3 | Experimental | Device: Auricular acupressurePerimenopausal symptoms |
| Auricular Acupressure Control Group3 | No intervention | –Perimenopausal symptoms |
| Exercise Group | Experimental | Behavioral: ExerciseObesity, DM, hypertension, cholesterol |
| Exercise Control Group | No intervention | –Obesity, DM, hypertension, cholesterol |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- people who
- aged 19 and older
- are able to read and respond to the questionnaire
- people who
- aged 19 and older
Key exclusion criteria (8 listed)
- people who are not able to read and respond to the questionnaire
- [Health Education]
- people who are not able to read and respond to the questionnaire
- [Auricular Acupressure]
- those who are pregnant
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 |
|---|---|---|
| Health educationFrequency: 12 sessions, once per week, one hour Will repeat three times a year. | Behavioural | Health Education Group |
| Auricular acupressureFrequency: 2 sessions, once per week for 2 weeks | Device | Auricular Acupressure Group1, Auricular Acupressure Group2, Auricular Acupressure Group3 |
| ExerciseFrequency: 8 sessions, once per week, one hour Will repeat three times a year | Behavioural | Exercise Group |
Primary outcome
Health Literacy (HLS-EU-Q47)
Time frame: baseline, 12 weeks
Health literacy will be assessed using the HLS-EU-Q47 (European Health Literacy Survey) developed by the World Health Organization (WHO) European Office. The tool will be used with permission after being translated and adapted by Chun Hee-Ran and Lee Ju-Yeol. It consists of 16 items, including 7 on healthcare, 5 on disease prevention, and 4 on health promotion, measured on a 4-point scale (very difficult to very easy). Responses of difficult/very difficult are scored as 0, while easy/very easy are scored as 1. Higher scores indicate greater health literacy (range 1-16). Based on total scores, 0-8 points indicate inadequate, 9-12 points indicate borderline, and 13 points or higher indicate sufficient health lieteracy.
Subjective Perception of Health (5-point Likert scale)
Time frame: baseline, 12 weeks
Subjective perception of health refers to an individual's self-assessment of their health status, whether good or poor. This is evaluated on a 5-point Likert scale with the responses: ① Very good, ② Good, ③ Fair, ④ Poor, and ⑤ Very poor. The subjective change in health status is a self-assessment of whether one's health has improved or worsened compared to a previous assessment. The question is: "How is your current health compared to the previous baseline survey?" Responses are measured on a 5-point Likert scale: ① Very much improved, ② Somewhat improved, ③ Same as before, ④ Somewhat worsened, and ⑤ Very much worsened (16).
Mental Health (Patient Health Questionnaire (PHQ-9))
Time frame: baseline, 12 weeks
The PHQ-9 (Patient Health Questionnaire) will assess the Mental Health. The PHQ-9 is a tool developed for diagnosing major depressive disorder and is widely used in primary healthcare settings. Participants are asked how often they experienced problems over the past two weeks, measured on a 4-point scale (Not at all to Nearly every day), with scores ranging from 0-27. Higher scores indicate more severe depressive symptoms. When using a cutoff score of 10, the sensitivity (94%) and specificity (80%) are high. Cronbach's alpha was reported as 0.84 among 125 Nepali primary care patients.
Quality of life (EQ-5D-5L Score)
Time frame: baseline, 12 weeks
Quality of life will be measured using the EQ-5D-5L, developed and translated in Nepalese by EuroQol. The EQ-5D-5L assesses current health status across five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each domain is rated on a 5-point scale from no problems to extreme problems. Reliability (ICC = 0.75). and one factor explained 88.3% of total variance. The EuroQol group provides a Nepali version of the tool, which will be used with approval.
10 secondary outcomes
Numeric Rating Scale for Symptoms (NRS)
Time frame: baseline, 12 weeks
Blood Pressure (automatic blood pressure cuff)
Time frame: baseline, 12 weeks
Fasting blood glucose level
Time frame: baseline, 12 weeks
Fasting Cholesterol Level
Time frame: baseline, 12 weeks
Effect of exercise (SIt-and-Reach Test Score)
Time frame: baseline, 8 weeks
Effect of exercise (Grip Strength Test)
Time frame: baseline, 8 weeks
Effect of exercise (Push-up and Sit-up Test (1-Minute Test))
Time frame: baseline, 8 weeks
Dysmenorrhea (Menstrual Distress Questionnaire (MEDI-Q))
Time frame: baseline, 2 weeks
Perimenopause symptoms (Perimenopausal Symptoms Rating Scale (MRS scale))
Time frame: baseline, 2 weeks
Disability in daily life due to musculoskeletal pain (Oswestry Disability Index(ODI))
Time frame: baseline. 2 weeks
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 29 Dec 2025.
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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 Health education, Auricular acupressure and Exercise in people with Health Promotion, run by Inha University Hospital at 1 site in South Korea.
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 9 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 29 Dec 2025. 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 South Korea. 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?
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 (HLS-EU-Q47) (time frame: baseline, 12 weeks). The study lists 4 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 29 Dec 2025.