A randomized-controlled intervention and evaluation of an innovative school health education (ISHE) project for primary schools in rural Bangladesh
| ISRCTN | ISRCTN18002856 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18002856 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | AEARCTR-0004265 |
| Sponsor | Meiji Gakuin University |
| Funders | Japan Society for the Promotion of Science, Nomura Foundation, Save the Children |
- Submission date
- 15/11/2023
- Registration date
- 17/11/2023
- Last edited
- 14/07/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
This research evaluates the effect and cost-effectiveness of skill-based health education (SBHE) in inducing healthier and hygienic practices among schools and pupils, and additionally improved health in pupils through a randomised-controlled trial (RCT) in primary schools in rural Bangladesh. In Bangladesh, despite efforts by the government and international community, children are still suffering from preventable diseases. The SBHE aims to improve the health-related school environment, and children’s health and health-related knowledge, attitudes, practices, and behaviour (KAPB).
Who can participate?
The participants are randomly selected schools and school pupils in Moheshpur and Kodchandpur, Jehnaidah District in Bangladesh.
What does the study involve?
The project delivers a once-a-week SBHE session to children, delivered by a trained para-teachers for a year.
What are the possible benefits and risks of participating?
Possible benefits of one-year SBHE school intervention are a healthier/cleaner school environment, improved health-related KAPB and health among the pupils. No risk for participants is expected.
Where is the study run from?
The intervention is run in Moheshpur and Kodchandpur, Jehnaidah District in Bangladesh.
When is the study starting and how long is it expected to run for?
April 2011 to March 2014
Who is funding the study?
This study was enabled by the research grants from the Japan Society for the Promotion of Science — Japanese Grant-in-Aid for Scientific Research (No. 23402033) and the Nomura Foundation, and by in-kind contribution and collaboration with Save the Children (SC), Inc. (originally SC, USA), Dhaka Office (Bangladesh)
Who is the main contact?
Makiko Omura, Meiji Gakuin University (makiko@eco.meijigakuin.ac.jp)
Contact information
Public, Scientific, Principal investigator
Meiji Gakuin University
1-2-37 Shirokanedai, Minato-ku
Tokyo
108-8636
Japan
 ORCID ID |
0000-0002-6970-7181 |
|---|---|
| Phone | +81-3-5421-5340 |
| makiko@eco.meijigakuin.ac.jp |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Participant information sheet | 44596 Child Assent Form.pdf |
| Scientific title | The effects of cluster Randomised-Controlled Intervention of Skill-Based Health Education (SBHE) on health and hygiene practice and behaviour among primary schools and pupils in rural Bangladesh |
| Study acronym | RCT-SBHE |
| Study objectives | The skill-based health education (SBHE) provided to schools have positive effects on healthy practice and behavioural change at both school and child levels. |
| Ethics approval(s) |
Approved 15/06/2011, Meiji Gakuin University Research Integrity Review Board (1-2-37 Shirokanedai, Minato-ku, Tokyo, 108-8636, Japan; +81-3-5421-5111; kenkyu@mguad.meijigakuin.ac.jp), ref: None provided |
| Health condition(s) or problem(s) studied | Healthy and hygiene behaviour: cold-related symptoms; other infectious disease (diarrhoea; scabbies); other health symptoms (stomachache; dizziness; fatigue; appetite loss) |
| Intervention | The proposed project applied a treatment-control pre-post evaluation based on a cross-cutting randomisation design of SBHE (HE) and a soap-provision (SP) intervention. The unit of intervention was school, and 180 randomly chosen schools out of total of 204 primary schools were stratified according to the school type—government primary school (GPS) and registered non-government primary school (RNGPS). A cross-cutting HE- SP treatments were then randomly assigned to 180 schools stratified by two school-type stratified. Thus, four groups (HE, SP, HESP, and control) with 45 school each were randomly chosen using Excel random classification formula by the author who was also the principal investigator. The process was repeated until statistical nondifference of baseline school characteristics between the groups was ensured. Children surveyed were chosen randomly using seat placement based on the pre-determined randomly selected seat numbers prescribed by the author. Surveyors were masked about the treatment status in both baseline and endline surveys. The baseline survey was conducted before the intervention in September–December 2011, and the endline data were collected in April–August 2013, after the completion of the intervention (March 2012–March 2013). The randomisation was done in January 2012 after the beginning of academic year in Bangladesh, thus the treatment status should not have affected the choice of school by the children and their families. Treatment randomisation ensured statistical nondifference between treatment and control schools at school level variables. We collected data from 180 schools, with 45 each randomly assigned for a cross-cutting HE-SP treatments. Data collection was done by the Dhaka based survey institute SURCH who received intensive training on the questionnaires, measurement and interview methods, subject random selection method by the author and conducted a pilot survey with the author. For school data, interviews were conducted to headteachers, and observational data were collected with photographs. For child level data, interviews and observational data were collected. All interviews and data collection used structured questionnaires. Data were collected from the interviewees upon informed consent The skill-based health education session consisted of 26 modules. An additional cross-cutting soap provision provided six small soap bars to soap-treatment schools and three small soap bars to randomly selected children in the soap-treatment schools. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
1. Handwashing practice: handwashing habit index (frequency and used materials before eating, after defecation, and after playing), frequency of handwashing with soap on each occasion, washing under running water, and correct handwashing procedure. |
| Key secondary outcome measure(s) |
1. nthropometry: height-, weight- (net of clothes) and BMI-for-age-z-score. |
| Completion date | 31/03/2014 |
Eligibility
| Participant type(s) | Learner/student |
|---|---|
| Age group | Child |
| Lower age limit | 5 Years |
| Upper age limit | 17 Years |
| Sex | All |
| Target sample size at registration | 180 |
| Total final enrolment | 180 |
| Key inclusion criteria | School children attending the selected schools |
| Key exclusion criteria | Declined to take part in the survey |
| Date of first enrolment | 11/10/2011 |
| Date of final enrolment | 08/07/2013 |
Locations
Countries of recruitment
- Bangladesh
Study participating centre
-
Bangladesh
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request form the principal investigator (Makiko Omura, makiko@eco.meijigakuin.ac.jp) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 11/07/2025 | 14/07/2025 | Yes | No | |
| Participant information sheet | Child assent form | 20/11/2023 | No | Yes | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- 44596 Child Assent Form.pdf
- Child assent form
Editorial Notes
14/07/2025: Publication reference added.
20/11/2023: The participant information sheet was uploaded as an additional file.
17/11/2023: Trial's existence confirmed by Meiji Gakuin University Research Integrity Review Board.
