UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053220 |
|---|---|
| Receipt number | R000060739 |
| Scientific Title | Effects of Hygiene Education and Hygiene Infrastructure Improvements on Health-Related Behaviors, Health Indicators, and School Absenteeism Among Children in Rural Nepal |
| Date of disclosure of the study information | 2024/01/31 |
| Last modified on | 2026/07/07 09:48:06 |
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Basic information
Public title
Effects of Hygiene Education and Hygiene Infrastructure Improvements on Health-Related Behaviors, Health Indicators, and School Absenteeism Among Children in Rural Nepal
Acronym
Effects of Hygiene Education and Hygiene Infrastructure Improvements on Health-Related Behaviors, Health Indicators, and School Absenteeism Among Children in Rural Nepal
Scientific Title
Effects of Hygiene Education and Hygiene Infrastructure Improvements on Health-Related Behaviors, Health Indicators, and School Absenteeism Among Children in Rural Nepal
Scientific Title:Acronym
Effects of Hygiene Education and Hygiene Infrastructure Improvements on Health-Related Behaviors, Health Indicators, and School Absenteeism Among Children in Rural Nepal
Region
| Japan | Asia(except Japan) |
Condition
Condition
The subjects are approximately 666 children attending eight schools in Pyuthan District, Nepal (Shree Shidhyashory Primary School, Baljyoti Primary School, Dipendra Primary School, Nepal National Primary School, Laxmi Secondary School, Bal Shiksha Secondary School, Jana Bikash Primary School, and Balkalyan Primary School).
Classification by specialty
| Dental medicine | Nursing | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the effects of hygiene education, the distribution of hygiene supplies, and the installation of handwashing facilities on health-related behaviors, health indicators, and school absenteeism among children in rural Pyuthan District, Nepal. Two intervention groups will be established: (1) a comprehensive intervention group receiving hygiene education, hygiene supplies, and handwashing facilities, and (2) a handwashing-facility-only group. Changes before and after the interventions, as well as differences between the two groups, will be evaluated. Furthermore, the behavioral change mechanisms underlying the interventions will be explored using the COM-B model to identify effective public health intervention strategies for rural communities.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Handwashing with soap, Oral health-related behaviors, Infectious disease symptoms (fever, cough, runny nose, and diarrhea), School absenteeism due to illness
Key secondary outcomes
Toothache, Difficulty chewing, Body mass index (BMI), Health knowledge, Perceived importance of health-related behaviors, Self-efficacy of health-related behaviors, Perceived changes following the installation of handwashing facilities
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Hygiene education, distribution of hygiene supplies, and installation of handwashing facilities
Interventions/Control_2
Installation of handwashing facilities
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 3 | years-old | <= |
Age-upper limit
| 14 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Ask elementary school students participating in the Rural Kids Help Project to cooperate.
Key exclusion criteria
No exclusion criteria.
Target sample size
666
Research contact person
Name of lead principal investigator
| 1st name | Akiko |
| Middle name | |
| Last name | Kondo |
Organization
Institute of Science Tokyo
Division name
International Nursing Development, Graduate School of Health Care Sciences
Zip code
1138519
Address
1-5-45 Yushima Bunkyo-ku Tokyo
TEL
0358035387
kondou.a.d25d@m.isct.ac.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Kondo |
Organization
Institute of Science Tokyo
Division name
International Nursing Development, Graduate School of Health Care Sciences
Zip code
1138519
Address
1-5-45 Yushima Bunkyo-ku Tokyo
TEL
0358035387
Homepage URL
kondou.a.d25d@m.isct.ac.jp
Sponsor or person
Institute
Institute of Science Tokyo
Institute
Department
Personal name
Funding Source
Organization
Institute of Science Tokyo
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institute of Science Tokyo
Address
1-5-45 Yushima Bunkyo-ku Tokyo
Tel
0358035387
kondou.a.d25d@m.isct.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
244
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2023 | Year | 12 | Month | 24 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 12 | Month | 25 | Day |
Last modified on
| 2026 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060739
