NCT05886101

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 2, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2024

Completed
Last Updated

June 2, 2023

Status Verified

May 1, 2023

Enrollment Period

9 months

First QC Date

March 29, 2023

Last Update Submit

May 23, 2023

Conditions

Work-Related ConditionMenstrual DiscomfortOccupational Problems

Keywords

Health literacyProductivityMenstrual self careHealth educationOccupational Nursing

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    6 months

Study Arms (2)

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

Behavioral: Health Education

Control

NO INTERVENTION

No health education will be provided. However, health information material will be distributed among the participants

Interventions

Health EducationBEHAVIORAL

Health education will be provided to the intervention group on health literacy, self care, productivity improvement

Intervention

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rokeya Akter Bristy

Dhaka, Dhamrai, 1350, Bangladesh

RECRUITING

MeSH Terms

Conditions

Health Education

Condition Hierarchy (Ancestors)

Adherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Michiko Moriyama

    Hiroshima University

    STUDY CHAIR

Central Study Contacts

ROKEYA AKTER BRISTY

CONTACT

+8801947354673gccn.bristy1@gmail.com

Jannatul Ferdous Mitu

CONTACT

+8801932780397ahmedmasqub@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 29, 2023

First Posted

June 2, 2023

Study Start

April 1, 2023

Primary Completion

December 30, 2023

Study Completion

February 28, 2024

Last Updated

June 2, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

BA(1)