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Active, not recruiting Not applicable

Effects of the Health Promotion Program on Health Literacy, Physical and Mental Health Status, and Quality of Life

NCT07306520 · tracked via the Priya Life Science South Korea tracker
Phase
Not applicable
Started
2024-12-25
Last updated
2025-12-29

Condition(s) studied

Health Promotion

Investigational drug(s) / intervention(s)

Health educationAuricular acupressureExercise

Health education: Frequency: 12 sessions, once per week, one hour Will repeat three times a year.

Auricular acupressure: Frequency: 2 sessions, once per week for 2 weeks

Exercise: Frequency: 8 sessions, once per week, one hour Will repeat three times a year

Study 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 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

1. 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.
2. 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.
3. 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.

Eligibility

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
Accepted
\[Health Screen\]: Inclusion Criteria: people who * aged 19 and older * are able to read and respond to the questionnaire Exclusion Criteria: people who are not able to read and respond to the questionnaire \[Health Education\] Inclusion Criteria: people who * aged 19 and older * who are able to read and respond to the questionnaire Exclusion Criteria: people who are not able to read and respond to the questionnaire \[Auricular Acupressure\] Inclusion Criteria: 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. Exclusion Criteria: * those who are pregnant * those with a metal allergy * those with ear-related disorders. \[Exercise\] Inclusion Criteria: 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

Primary outcome measure(s)

  • Health Literacy (HLS-EU-Q47) — 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) — 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)) — 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) — 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.

Trial sites (1)

FacilityCityRegionStatus
Inha University Hospital Incheon South Korea
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07306520 on ClinicalTrials.gov ↗ ← All trials in South Korea