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

NCT07306520 | Active Not Recruiting DMC

• 1 other identifier: 241015-1A
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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. 1.Health Education Program:
2. 2.Exercise Program:
3. 3.Auricular Acupressure:

Conditions

Health Promotion

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

Outcome Measures

Primary Outcomes (4)

• 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.

  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).

  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.

  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.

  baseline, 12 weeks

Secondary Outcomes (10)

• Numeric Rating Scale for Symptoms (NRS)

  baseline, 12 weeks

• Blood Pressure (automatic blood pressure cuff)

  baseline, 12 weeks

• Fasting blood glucose level

  baseline, 12 weeks

• Fasting Cholesterol Level

  baseline, 12 weeks

• Effect of exercise (SIt-and-Reach Test Score)

  baseline, 8 weeks

Study Arms (10)

Health Education Group

EXPERIMENTAL

Obesity, DM, hypertension, cholesterol

Behavioral: Health education

Health Education Control Group

NO INTERVENTION

Obesity, DM, hypertension, cholesterol

Auricular Acupressure Group1

EXPERIMENTAL

Back pain

Device: Auricular acupressure

Auricular Acupressure Control Group1

NO INTERVENTION

Back pain

Auricular Acupressure Group2

EXPERIMENTAL

Dysmenorrhea

Device: Auricular acupressure

Auricular Acupressure Control Group2

NO INTERVENTION

Dysmenorrhea

Auricular Acupressure Group3

EXPERIMENTAL

Perimenopausal symptoms

Device: Auricular acupressure

Auricular Acupressure Control Group3

NO INTERVENTION

Perimenopausal symptoms

Exercise Group

EXPERIMENTAL

Obesity, DM, hypertension, cholesterol

Behavioral: Exercise

Exercise Control Group

NO INTERVENTION

Obesity, DM, hypertension, cholesterol

Interventions

Health education BEHAVIORAL

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

Health Education Group

Auricular acupressure DEVICE

Frequency: 2 sessions, once per week for 2 weeks

Auricular Acupressure Group1; Auricular Acupressure Group2; Auricular Acupressure Group3

Exercise BEHAVIORAL

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

Exercise Group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• people who
• aged 19 and older
• are able to read and respond to the questionnaire

You may not qualify if:

• people who are not able to read and respond to the questionnaire
• \[Health Education\]
• people who
• aged 19 and older
• who are able to read and respond to the questionnaire
• people who are not able to read and respond to the questionnaire
• \[Auricular Acupressure\]
• 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.
• those who are pregnant
• those with a metal allergy
• those with ear-related disorders.
• \[Exercise\]
• Residents aged 19 and older who are able to read and respond to the questionnaire will be recruited for health screenings and surveys.

Sponsors & Collaborators

• Inha University Hospital: lead

Study Sites (1)

Inha University Hospital

Incheon, South Korea

Location

MeSH Terms

Conditions

Psychological Well-Being; Chronic Disease; Health Behavior; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: PRECEDE-PROCEED Model

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 29, 2025
• Study Start: December 25, 2024
• Primary Completion (Estimated): March 31, 2031
• Study Completion (Estimated): March 31, 2031
• Last Updated: December 29, 2025

Record last verified: 2025-12

Locations

KR (1)