Work-Related ConditionNCT05886101
Increase Health Literacy Through Health Education to Improve Menstruation Related Self-care and Work Productivity
A study testing Health Education in people with Work-Related Condition and Menstrual Discomfort, run by Hiroshima University at 1 site in Bangladesh.
Trial summary
The aim of the study is to increase health literacy, especially in menstruation self-care, and empower female RMG workers through health education by an occupational nurse, and as a consequent improve work productivity in RMG factories in Dhaka, Bangladesh Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Work-Related Condition, Menstrual Discomfort, Occupational Problems
- What is being tested?
- Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 Apr 2023to 28 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women
- Age (18-49 years old)
- Who is having menstruation or not
- Who will be willing to participate
- Who will like to be stay in the job for 6 months
- Who will give consent to share information for the study
- Who will willing to take part in the health educatio
Who cannot join
- Men and self-identified male or female (the third gender)
- The reason: we measure menstruation practice
- ● Who does not belong to the assigned division or move out during the research period
- (We use their data until they are present in the study)
- Who will not be willing to participate
- Who is in leave position at the time of survey
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site, 1 recruiting
- Recruiting
Rokeya Akter Bristy
Dhaka, Dhamrai, 1350
ROKEAYA AKTER BRISTY, 01947354673
JANNATUL FERDOUS MITU, 01932780397, ahmedmasqub@gmail.com
About this study
Official title: Increase Health Literacy Through Health Education Among-women Working in Readymade Garments (RMGs) to Improve Menstruation Related Self-care and Work Productivity"
The aim of the study is to increase health literacy, especially in menstruation self-care, and empower female RMG workers through health education by an occupational nurse, and as a consequent improve work productivity in RMG factories in Dhaka, Bangladesh
Read the detailed description
Background: Health literacy is the degree to which an individual has the capacity to obtain, process and understand basic health information needed to make appropriate health decisions. Bangladesh is a low-income country with low health literacy levels amongst its citizens. The concept of health literacy and self-care is difficult to understand for many people. This failure to understand the concept of health literacy impacts on both the national health and the economy. Nevertheless, the health status of the garments workers is greatly affected by their working environment. Unfortunately, the factory environment is not healthy enough to protect their health. In most cases they are the main source of income in their family (Mahmud et al., 2018). Although, they are contributing in countries economy, they are suffering from different types of health problems.
Study Objective:
Increase health literacy especially in menstruation self-care and empower female RMG workers through health education by an occupational nurse, and as a consequent improve work productivity in RMG factories in Dhaka, Bangladesh
Hypothesis:
Increased health literacy amongst the women who work in RMG factories will improve the self-care practice, which consequently improves work productivity of the company.
Method: An experimental design will be used to conduct the study in RMG factories in Bangladesh. The intervention period will be for six months. A total of 4 factories are selected, which will be cluster-+randomized into the intervention group and the control group. All of them are situated in the Dhaka district. Two of them are in Mirpur Thana, one is in Ashulia upazilla, and another one is in Valuka upazilla. The intervention group will receive health education, and the control group will only receive the survey. The primary outcome is the improvement of health literacy among women working in RMGs. The secondary outcomes are improved self-care, menstrual hygiene, and empowered work productivity.
Conclusion: All interested parties would be offered the opportunity to review the results of this survey. All participants of the questionnaire would be informed of the outcomes. As the work will be carefully viewed by the student's dissertation supervisor to be of a high standard then publication in a suitable journal would be appropriate
- Being tested
- Health Education
- Keywords
- Health literacy, Productivity, Menstrual self care, Health education, Occupational Nursing
- Medical subject headings
- Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health EducationBehavioural
Health education will be provided to the intervention group on health literacy, self care, productivity improvement
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Intervention factory with health education program
1. Health education will be provided on menstrual hygiene management and improve health literacy.
2. Behavior change communications program Receives: Behavioral: Health Education |
| Control | No intervention | No health education will be provided. However, health information material will be distributed among the participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of health literacy measured by European health literacy scale (12-items short version) (Finbraten et al., 2018) among women in Ready Made Garments (RMG) sector in Bangladesh
Assessing the level of health literacy among RMG workers in Bangladesh. European health literacy scale will be used. The reporting will be done using the likert scale on a score of (1-4). Where 1 is counted as no literacy and 4 means higher literacy level. Health literacy of the garments worker will be checked by trained graduate nurses. Health education will be provided by using multimedia and data will be collected at baseline, midline and endline.
Measured: 6 months
Secondary outcomes (1)
Improve reproductive age women specific health literacy by using the Health literacy scale for women of reproductive age, Bangla version (From Japanese to Bangla and standardized in Study
Improvement on reproductive health literacy. Reproductive Women's health literacy scale. Likert scale will be used. score range is (1-4). 1= poor 2=below average, 3= good, 4 =excellent. The validity and reliability will be assessed according to the social context of Bangladesh
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start1 Apr 2023
- Primary completion30 Dec 2023 (estimated)
- Study completion28 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Work-Related ConditionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hiroshima University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rokeya Akter Bristy, Hiroshima University
- Investigators
- Michiko Moriyama, Study chair, Hiroshima University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05886101
- Sponsor's protocol ID
- Health literacy & productivity
- Status last verified
- May 2023
- First submitted
- 29 Mar 2023
- Last updated
- 2 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increase Health Literacy Through Health Education Among-women Working in Readymade Garments (RMGs) to Improve Menstruation Related Self-care and Work Productivity"
- ClinicalTrials.gov ID
- NCT05886101
- Acronym / sponsor ID
- Health literacy & productivity
- Keywords
- Health literacy, Productivity, Menstrual self care, Health education, Occupational Nursing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Hiroshima UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 28 Feb 2024 (estimated)
- First posted
- 2 Jun 2023 (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.
The aim of the study is to increase health literacy, especially in menstruation self-care, and empower female RMG workers through health education by an occupational nurse, and as a consequent improve work productivity in RMG factories in Dhaka, Bangladesh
Detailed description
Background: Health literacy is the degree to which an individual has the capacity to obtain, process and understand basic health information needed to make appropriate health decisions. Bangladesh is a low-income country with low health literacy levels amongst its citizens. The concept of health literacy and self-care is difficult to understand for many people. This failure to understand the concept of health literacy impacts on both the national health and the economy. Nevertheless, the health status of the garments workers is greatly affected by their working environment. Unfortunately, the factory environment is not healthy enough to protect their health. In most cases they are the main source of income in their family (Mahmud et al., 2018). Although, they are contributing in countries economy, they are suffering from different types of health problems.
Study Objective:
Increase health literacy especially in menstruation self-care and empower female RMG workers through health education by an occupational nurse, and as a consequent improve work productivity in RMG factories in Dhaka, Bangladesh
Hypothesis:
Increased health literacy amongst the women who work in RMG factories will improve the self-care practice, which consequently improves work productivity of the company.
Method: An experimental design will be used to conduct the study in RMG factories in Bangladesh. The intervention period will be for six months. A total of 4 factories are selected, which will be cluster-+randomized into the intervention group and the control group. All of them are situated in the Dhaka district. Two of them are in Mirpur Thana, one is in Ashulia upazilla, and another one is in Valuka upazilla. The intervention group will receive health education, and the control group will only receive the survey. The primary outcome is the improvement of health literacy among women working in RMGs. The secondary outcomes are improved self-care, menstrual hygiene, and empowered work productivity.
Conclusion: All interested parties would be offered the opportunity to review the results of this survey. All participants of the questionnaire would be informed of the outcomes. As the work will be carefully viewed by the student's dissertation supervisor to be of a high standard then publication in a suitable journal would be appropriate
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Behavioral: Health EducationIntervention factory with health education program 1. Health education will be provided on menstrual hygiene management and improve health literacy. 2. Behavior change communications program |
| Control | No intervention | –No health education will be provided. However, health information material will be distributed among the participants |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Women
- Age (18-49 years old)
- Who is having menstruation or not
- Who will be willing to participate
- Who will like to be stay in the job for 6 months
Key exclusion criteria (6 listed)
- Men and self-identified male or female (the third gender)
- The reason: we measure menstruation practice
- ● Who does not belong to the assigned division or move out during the research period
- (We use their data until they are present in the study)
- Who will not be willing to participate
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 EducationHealth education will be provided to the intervention group on health literacy, self care, productivity improvement | Behavioural | Intervention |
Primary outcome
Improvement of health literacy measured by European health literacy scale (12-items short version) (Finbraten et al., 2018) among women in Ready Made Garments (RMG) sector in Bangladesh
Time frame: 6 months
Assessing the level of health literacy among RMG workers in Bangladesh. European health literacy scale will be used. The reporting will be done using the likert scale on a score of (1-4). Where 1 is counted as no literacy and 4 means higher literacy level. Health literacy of the garments worker will be checked by trained graduate nurses. Health education will be provided by using multimedia and data will be collected at baseline, midline and endline.
1 secondary outcome
Improve reproductive age women specific health literacy by using the Health literacy scale for women of reproductive age, Bangla version (From Japanese to Bangla and standardized in Study
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2023.
- Individual participant dataSharing planned: No
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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.
Michiko Moriyama study chair
Hiroshima University
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 in people with Work-Related Condition and Menstrual Discomfort, run by Hiroshima University at 1 site in Bangladesh.
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 7 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 2 Jun 2023. 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 Bangladesh. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ROKEYA AKTER BRISTY (+8801947354673, gccn.bristy1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of health literacy measured by European health literacy scale (12-items short version) (Finbraten et al., 2018) among women in Ready Made Garments (RMG) sector in Bangladesh (time frame: 6 months). 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 2 Jun 2023.