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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06084429
Other study ID # 2023/OR-NSU/IRB/0707
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 24, 2024
Est. completion date November 30, 2024

Study information

Verified date November 2023
Source Hiroshima University
Contact Popi Rani Bhowmik, Doctoral Student (current)
Phone +8801775965487
Email d224513@hiroshima-u.ac.jp
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Health literacy is a person's decision-making ability to improve their quality of life and prevent diseases by accessing, understanding and applying health information. Health literacy in the adolescent's period can aid them to gain and understand health information which can bring positive health outcomes. The aim of this pilot study is to examine the efficacy of health education and school health activities provided by school nurses on improving health literacy among secondary school adolescents. The study will also examine whether health education by health champions (the adolescents) is effective in improving the health literacy of the community people, and examine whether these interventions develop awareness, improve health knowledge, empower, and change behaviors of secondary school adolescents. This intervention study aims to improve health literacy in the adolescents in Bangladesh and the school-located community. The Begum Ayesha Pilot Girl's High School in Dohar, Dhaka district will be selected as a field. First, we will place school nurses at the school, provide health checkups for both the adolescents (about n=316) and community people (about n=200), and school nurses will provide weekly health education for 3 months to the adolescents. After certifying them as "Health Champions", the health champions visit the community and provide health education activities to the community people. For both participant groups, health literacy will be measured as efficacy checking of this pilot study. Assent and informed consent will be obtained from the participants. Autonomy, beneficence, non-maleficence, fidelity, veracity, confidentiality, and justice of the participants will be ensured. Also, anonymity will be maintained across all stages of the study.


Recruitment information / eligibility

Status Recruiting
Enrollment 298
Est. completion date November 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 11 Years to 18 Years
Eligibility Inclusion Criteria: For school adolescents: - Students who are willing to participate. - Students who study in class 8 (Grade 8) at the time of enrollment. - Students who are female. - Students whose parents or legal guardians agree to give consent and are willing to participate in the study - Students who agree to receive health checkup, and are willing to respond to the questionnaire. - Students who will stay in the same school till study completion. For community people: - Persons who are aged at least 18 years old. - Persons who are willing to participate. - Persons who agree to receive health checkup, and willing to respond to the questionnaire. - Persons who will attend the health education activities. Exclusion Criteria: For school adolescents: • Students who are absent from school during the health checkup periods due to severe illness or without any reason or information For community people: - Persons who will not attend the education sessions physically. - Persons who will not live in the community until the post-test.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
pre and post test (health educational intervention)
The health education will be provided the following sessions. Introduction to Global and Bangladesh Health, Health Information access (Validity), Critical Values (Vital signs, BMI, RBS etc.), Emergency Management (burn, chocking, knife cut, fainting etc.), Food (classification, healthy food, unhealthy, food label, salt intake) (NCDs from unhealthy diet), Smoking and Alcohol (NCD related, substance abuse, secondhand smoking), Physical activity (Benefits, sedentary lifestyle, NCD related), Women's health (menstruation, menstrual cycle, hygiene, STD, contraception), Hygiene (water, food, brushing, bath, toileting, healthy habits), Environmental Sanitation and Communicable disease (clean, effects on health), and Women's health and societal contribution

Locations

Country Name City State
Bangladesh Begum Ayesha Pilot Girls' High School And College Dhaka Dohar

Sponsors (1)

Lead Sponsor Collaborator
Hiroshima University

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in health literacy score among the secondary school students Primary outcome will be measured by the health literacy scale for school-aged Children (HLSAC), Bangla version. Baseline, Midline (after 3 months of baseline), Endline (after 6 months of baseline)
Secondary Change in ratio of the level of health literacy This will be measured by HLSAC, Bangla version. Baseline, Midline (after 3 months of baseline), Endline (after 6 months of baseline)
Secondary Change in self-efficacy score this will be measured by General Self-Efficacy Scale (GSE) Baseline, Midline (after 3 months of baseline), Endline (after 6 months of baseline)
Secondary Change in reproductive age women specific health literacy This will be measured by using the Health literacy scale for women of reproductive age, Bangla version Baseline, Midline (after 3 months of baseline), Endline (after 6 months of baseline)
Secondary Change in awareness and knowledge score This will be measured by the researcher-developed scale Baseline, Midline (after 3 months of baseline), Endline (after 6 months of baseline)
Secondary Change in health behavior score this will be measured by the researcher-developed scale Baseline, Midline (after 3 months of baseline), Endline (after 6 months of baseline)
Secondary Qualitative self-evaluation attending the project and being a health champion Data will be collected through a open qualitative questionnaire (one/two questions will be asked the participants to share their experience for being a health champion and data will be recorded using a voice recorder). Endline (after 6 months of baseline)
Secondary For community people- Change in health literacy score This will be measured by the European Health literacy Survey Questionnaire short version (HLS-Q12), Bangla version, which is developed by Finbraten, 2018 in English Midline (after 3 months of baseline), Endline (after 6 months of baseline)
Secondary For community people- Change in awareness and knowledge score This will be measured by the researcher-developed scale Midline (after 3 months of baseline), Endline (after 6 months of baseline)
Secondary For community people- Change in health behavior score This will be measured by the researcher-developed scale Midline (after 3 months of baseline), Endline (after 6 months of baseline)
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