Handwashing BehaviorsNCT02617225
Effect of a Pilot Group Hand-washing Program on Handwashing Behaviors Among Elementary School Children in Assam
An observational study of Handwashing Behaviors, run by Network for Engineering and Economics Research and Management at 1 site in India.
Trial summary
The United Nation's International Children's Emergency Fund (UNICEF) is supporting Saba Shikha Abihyan (SSA) (Education-for-All Mission) of the Government of Assam (GoA) under their Water-Sanitation-Hygiene in School (WinS) program to improve WASH facilities, practices and institutionalize WASH in school settings. Read more about this study
- Who is it for?
- Ages 8 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Handwashing Behaviors
- What is being tested?
- DHaAL Intervention and DHaAL + CFSS Intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 823 participants
- Where
- 1 siteIndia
- Study dates
- Nov 2015to Sep 2016
- Phase
- Observational
- 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 8 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Elementary schools (Class 1-5) from five education blocks in Kamrup district. The respondents/participants include school teachers (Interview/observations), Class 1-5 students (distant observation), Class 3-5 students (personal Interviews/observations) and their parents/other household members (personal Interview/observations).
Who may be able to join
- Should be present in the school on the day of interview/survey
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of DHaAL Intervention of Group Handwashing With Soap Before Mid-day Meals in Rural Elementary School of Assam
The United Nation's International Children's Emergency Fund (UNICEF) is supporting Saba Shikha Abihyan (SSA) (Education-for-All Mission) of the Government of Assam (GoA) under their Water-Sanitation-Hygiene in School (WinS) program to improve WASH facilities, practices and institutionalize WASH in school settings. Under the WinS program, UNICEF piloted a group hand washing program in 100 elementary schools. Multiple past studies have shown that handwashing is an effective intervention to reduce diarrheal diseases and respiratory tract infections, but the evidence on the interventions or programs that can achieve this behavior change is mixed and limited in case of school setting. The main objective of Daily Handwashing for an Ailment-free Life (DHaAL) program was to institutionalize handwashing with soap before consuming mid-day meals and after using toilets among elementary school students. DHaAL is implemented on the Mid-day Meal platform where free meals are given to all students attending government schools.
In addition to the standard DHaAL intervention, several pilot phase schools also received an additional program for a holistic and participatory development of school systems for health, nutrition, learning outcomes and wellbeing of children called Child Friendly School System (CFSS). Although CFSS is not a WASH intervention it can develop systems and processes and offer longer support from and implementing agencies which help DHaAL Intervention also.
This evaluation study seeks to answer whether DHaAL improved handwashing practice before the mid-day meals in rural lower primary schools as a primary research question. The intermediate outputs and secondary outcomes evaluated in this study include functionality of handwashing infrastructure at school, handwashing practice after toilet use, and availability of and use of handwashing facilities at homes (indirect effect). The evaluation study has other supplemental operations research objectives to help improve the program in future.
- Conditions
- Handwashing Behaviors
- Being tested
- DHaAL Intervention, DHaAL + CFSS Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DHaAL InterventionBehavioural
This group handwashing program is for rural elementary schools to institutionalize the practice of handwashing before mid-day meal consumption and after use of toilets by harnessing the theory of social peer pressure.
DHaAL intervention consists of: (1) capacity building of school teachers to implement group handwashing; (2) installing group handwashing station; (3) generating demand among students to wash hands in group; and (4) establishing systems to sustain handwashing infrastructure and behaviors.
DHaAL + CFSS InterventionBehavioural
In addition to support under DHaAL, several intervention schools receive a more holistic and participatory support that focuses on health, safety, nutrition status, and psychological wellbeing of the children, and thus can also influence handwashing practices (and other WASH facilities). CFSS provides capacity building support and establishes systems to improve school environment, learning outcome, teachers capacity, and physical education for children.
| Study group | Role | What they receive |
|---|---|---|
| DHaAL Intervention | The group receives standard Ailment-free Life (DHaAL) DHaAL intervention Receives: Behavioral: DHaAL Intervention | |
| DHaAL +CFSS Intervention | This group received the standard DHaAL intervention and additional support under another UNICEF program named Child Friendly School System (CFSS). Receives: Behavioral: DHaAL Intervention; Behavioral: DHaAL + CFSS Intervention | |
| Control | This group receive the standard / business-as-usual support from the Education Department, but does not receive DHaAL or CFSS Interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Class 1-5 children washing hands with soap before consuming mid-day meals in schools
Measured: On the day of interview (~12-24 months after the external support under DHaAL ceased)
Secondary outcomes (3)
Proportion of Class 1-5 children washing hands with soap after the use of toilets for defecation or urination in schools
Measured: On the day of interview (~12-24 months after the external support under DHaAL ceased)
Proportion of schools having a functional handwashing station with water and soap
Measured: On the day of interview (~12-24 months after the external support under DHaAL ceased)
Proportion of households having a functional handwashing station with water and soap
This is an indirect or spill over effect of the intervention
Measured: On the day of interview (~12-24 months after the external support under DHaAL ceased)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionJun 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Handwashing BehaviorsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 823 participants (actual)
Sponsor and investigators
- Lead sponsor
- Network for Engineering and Economics Research and Management
- Sponsor type
- University, hospital or other
- Collaborators
- UNICEF
- Responsible party
- Sponsor
- Investigators
- Sumeet Patil, Principal investigator, Network for Engineering and Economics Research and Management
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02617225
- Sponsor's protocol ID
- 2016/06/UNICEF01
- Status last verified
- Feb 2020
- First submitted
- 27 Nov 2015
- Last updated
- 2 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of DHaAL Intervention of Group Handwashing With Soap Before Mid-day Meals in Rural Elementary School of Assam
- ClinicalTrials.gov ID
- NCT02617225
- Acronym / sponsor ID
- 2016/06/UNICEF01
- Conditions
- Handwashing Behaviors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 823 participants (actual)
- Lead sponsor
- Network for Engineering and Economics Research and ManagementUniversity, hospital or other
- Collaborators
- UNICEF
- Study start
- Nov 2015 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 30 Nov 2015 (estimated)
- 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 United Nation's International Children's Emergency Fund (UNICEF) is supporting Saba Shikha Abihyan (SSA) (Education-for-All Mission) of the Government of Assam (GoA) under their Water-Sanitation-Hygiene in School (WinS) program to improve WASH facilities, practices and institutionalize WASH in school settings. Under the WinS program, UNICEF piloted a group hand washing program in 100 elementary schools. Multiple past studies have shown that handwashing is an effective intervention to reduce diarrheal diseases and respiratory tract infections, but the evidence on the interventions or programs that can achieve this behavior change is mixed and limited in case of school setting. The main objective of Daily Handwashing for an Ailment-free Life (DHaAL) program was to institutionalize handwashing with soap before consuming mid-day meals and after using toilets among elementary school students. DHaAL is implemented on the Mid-day Meal platform where free meals are given to all students attending government schools.
In addition to the standard DHaAL intervention, several pilot phase schools also received an additional program for a holistic and participatory development of school systems for health, nutrition, learning outcomes and wellbeing of children called Child Friendly School System (CFSS). Although CFSS is not a WASH intervention it can develop systems and processes and offer longer support from and implementing agencies which help DHaAL Intervention also.
This evaluation study seeks to answer whether DHaAL improved handwashing practice before the mid-day meals in rural lower primary schools as a primary research question. The intermediate outputs and secondary outcomes evaluated in this study include functionality of handwashing infrastructure at school, handwashing practice after toilet use, and availability of and use of handwashing facilities at homes (indirect effect). The evaluation study has other supplemental operations research objectives to help improve the program in future.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DHaAL Intervention | – | Behavioral: DHaAL InterventionThe group receives standard Ailment-free Life (DHaAL) DHaAL intervention |
| DHaAL +CFSS Intervention | – | Behavioral: DHaAL Intervention, Behavioral: DHaAL + CFSS InterventionThis group received the standard DHaAL intervention and additional support under another UNICEF program named Child Friendly School System (CFSS). |
| Control | – | –This group receive the standard / business-as-usual support from the Education Department, but does not receive DHaAL or CFSS Interventions. |
Who may qualify
- Ages
- 8 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Elementary schools (Class 1-5) from five education blocks in Kamrup district. The respondents/participants include school teachers (Interview/observations), Class 1-5 students (distant observation), Class 3-5 students (personal Interviews/observations) and their parents/other household members (personal Interview/observations).
Key inclusion criteria (1 listed)
- Should be present in the school on the day of interview/survey
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| DHaAL InterventionThis group handwashing program is for rural elementary schools to institutionalize the practice of handwashing before mid-day meal consumption and after use of toilets by harnessing the theory of social peer pressure. DHaAL intervention consists of: (1) capacity building of school teachers to implement group handwashing; (2) installing group handwashing station; (3) generating demand among students to wash hands in group; and (4) establishing systems to sustain handwashing infrastructure and behaviors. | Behavioural | DHaAL +CFSS Intervention, DHaAL Intervention |
| DHaAL + CFSS InterventionIn addition to support under DHaAL, several intervention schools receive a more holistic and participatory support that focuses on health, safety, nutrition status, and psychological wellbeing of the children, and thus can also influence handwashing practices (and other WASH facilities). CFSS provides capacity building support and establishes systems to improve school environment, learning outcome, teachers capacity, and physical education for children. | Behavioural | DHaAL +CFSS Intervention |
Primary outcome
Proportion of Class 1-5 children washing hands with soap before consuming mid-day meals in schools
Time frame: On the day of interview (~12-24 months after the external support under DHaAL ceased)
3 secondary outcomes
Proportion of Class 1-5 children washing hands with soap after the use of toilets for defecation or urination in schools
Time frame: On the day of interview (~12-24 months after the external support under DHaAL ceased)
Proportion of schools having a functional handwashing station with water and soap
Time frame: On the day of interview (~12-24 months after the external support under DHaAL ceased)
Proportion of households having a functional handwashing station with water and soap
Time frame: On the day of interview (~12-24 months after the external support under DHaAL ceased)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2020.
Related trials for Handwashing Behaviors
Not yet recruiting
Effect of Digital Method-Based Hand Hygiene Education on Handwashing Skills in Primary School Students
Hand Hygiene, School Health, Primary School Students, Health Education
Not yet recruiting
Game-Based Handwashing Education in Preschool Children
Handwashing Behavior
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.
Sumeet Patil principal investigator
Network for Engineering and Economics Research and Management
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Handwashing Behaviors, run by Network for Engineering and Economics Research and Management at 1 site in India.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 2 Mar 2020. 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 India. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Class 1-5 children washing hands with soap before consuming mid-day meals in schools (time frame: On the day of interview (~12-24 months after the external support under DHaAL ceased)). 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 Mar 2020.