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 |
| Secondary identifying numbers | AEARCTR-0004265 |
- 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
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | School |
| Study type | Other |
| 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 | 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. 2. Dental-care practice: dentalcare index (frequency); tooth-brushing frequency using brush/branch; combination of used materials such as fingers, branch to brush, with ash, coal, powder and/or paste. 3. Oher hygiene practice: shoe-wearing habits at school; shoe-wearing habits at home (inside latrine and in courtyard). 4. Hand cleanliness: clean hands, trimmed nails, and clean nails; adenosine triphosphate (ATP): ATP improvement rate comparing before and after handwashing. 5. Nutrition practice: breakfast taken, and food taken for the past three days, ordered by the richness of the nutrition score and categorised into three categories (none; carbohydrate and vitamins; carbohydrate, protein and plus). 6. Health/hygiene knowledge: handwashing procedure; breakfast important; putting water in latrine before defecating (endline only), oral rehydration solution (ORS) making (endline only), food pyramid (endline only). |
| Secondary outcome measures | 1. nthropometry: height-, weight- (net of clothes) and BMI-for-age-z-score. * Given the fact that WHO Growth Chart for weight is only available for 5-10 years, while that for height and BMI is available for 5-19 years, the British 1990 Growth Charts available for 0-20 years were utilised to calculate the z-scores. 2. Cold-related symptoms: cough, breathing difficulty, sore throat, fever, running nose, and congested nose at present and in the past two-weeks. 3. Other illness: diarrhoea, stomachache, scabies in the past two-weeks, fatigue, dizziness, and appetite loss. |
| Overall study start date | 01/04/2011 |
| 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 | Both |
| Target number of participants | 180 (40/50 per cluster) |
| 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
Sponsor information
University/education
1-2-37 Shirokanedai, Minato-ku
Tokyo
108-8636
Japan
| Phone | +81-3-5421-5111 |
|---|---|
| kenkyu@mguad.meijigakuin.ac.jp | |
| Website | https://www.meijigakuin.ac.jp/ |
"ROR" |
https://ror.org/01zwcys39 |
Funders
Funder type
Research organisation
Government organisation / National government
- Alternative name(s)
- KAKENHI, 日本学術振興会, Gakushin, JSPS KAKEN, JSPS Grants-in-Aid for Scientific Research, JSPS
- Location
- Japan
Private sector organisation / Trusts, charities, foundations (both public and private)
- Location
- Japan
No information available
Results and Publications
| Intention to publish date | 01/01/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| 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? |
|---|---|---|---|---|---|
| Participant information sheet | Child assent form | 20/11/2023 | No | Yes | |
| Results article | 11/07/2025 | 14/07/2025 | Yes | No |
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.
