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临床试验/NCT07306520
NCT07306520
进行中(未招募)
不适用

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

Inha University Hospital1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2024年12月25日最近更新:

概览

阶段
不适用
状态
进行中(未招募)
入组人数
400
试验地点
1
主要终点
Health Literacy (HLS-EU-Q47)

概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • people who are not able to read and respond to the questionnaire
  • \[Health Education\]
  • Inclusion Criteria:
  • 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.

结局指标

主要结局

Health Literacy (HLS-EU-Q47)

时间窗: 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)

时间窗: 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))

时间窗: 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)

时间窗: 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.

次要结局

  • 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)
  • Effect of exercise (Grip Strength Test)(baseline, 8 weeks)
  • Effect of exercise (Push-up and Sit-up Test (1-Minute Test))(baseline, 8 weeks)
  • Dysmenorrhea (Menstrual Distress Questionnaire (MEDI-Q))(baseline, 2 weeks)
  • Perimenopause symptoms (Perimenopausal Symptoms Rating Scale (MRS scale))(baseline, 2 weeks)
  • Disability in daily life due to musculoskeletal pain (Oswestry Disability Index(ODI))(baseline. 2 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

EUN JIN LEE

Professor

Inha University Hospital

研究点 (1)

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