- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02703974
Nudging Handwashing: a Cluster-randomized Trial in Bangladesh
The study will collect and analyze quantitative data regarding handwashing behaviors among school-aged children to determine the impact of nudges compared to handwashing and hygiene education programs.
Based on the success of the preliminary pilot, we hypothesize nudges leading to higher rates of handwashing than traditional handwashing and hygiene education programs.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study will utilize a cluster-randomized trial design to collect quantitative data and analyze the handwashing behaviors of school-aged children.
The primary purpose of this protocol is to assess nudges as a viable method of promoting handwashing among school-aged children.
The specific objectives of this quantitative exploration are to:
- Determine if nudges can prompt significant behavior change and result in higher rates of handwashing among school-aged children in Bangladesh
- Determine if behavior change resulting from nudging is sustainable over time
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Dhaka, Bangladesh, 1212
- Save the Children
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
schools in Dhunat, Gurudaspur and Boraigram Upazilla (sub districts) of Bogra and Natore districts of Rajshahi Division that that meet the following inclusion criteria:
- No hygiene education programs in the last two years
- No handwashing stations or facilities on school grounds
- Improved sanitation/toilets facilities (latrines)
- Water supply on site or within 3-6 meters of the school
- A school population between 125-450 students, and
- A government primary school (all co-ed)
- Willingness of the school principle / head teacher and a representative of the School Management Committee (SMC) to participate in the proposed research
Exclusion Criteria:
- Located outside of Dhunat, Gurudaspur and Boraigram Upazilla (sub districts) of Bogra and Natore districts of Rajshahi Division
- Have had a hygiene education program in the last two years
- Already has handwashing stations or facilities on school grounds
- Does not have improved sanitation/toilets facilities (latrines)
- Does not have water supply on site or within 3-6 meters of the school
- Has a school population under 125 or over 450 students
- Is not a government primary school or is not co-ed
- School principle / head teacher or representative of the School Management Committee (SMC) is not willing to participate in the proposed research
Study Plan
How is the study designed?
Design Details
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Early handwashing station + nudge
This arm will include 5 randomly selected schools that will have had handwashing stations built after the baseline observation (Phase I), and nudges built after Phase II data collection.
|
A handwashing station will be a dedicated location for handwashing in each selected school and will include:
The early handwashing stations will be constructed in weeks 1 and 2 of the study, after the baseline observations (Phase I) are complete. A nudge will be built in each randomly selected school and will consist of:
The nudges will be constructed at the end of week 3 and 4, after Phase II data collection is complete within each randomly assigned nudge school. |
|
EXPERIMENTAL: Late handwashing station + nudge
This arm will include 5 randomly selected schools that will have had handwashing stations and nudges built at the same time, after Phase II data collection.
|
A nudge will be built in each randomly selected school and will consist of:
The nudges will be constructed at the end of week 3 and 4, after Phase II data collection is complete within each randomly assigned nudge school. A handwashing station will be a dedicated location for handwashing in each selected school and will include:
The late handwashing stations construction will begin after Phase 2 data collection has been finished at the end of week 3. |
|
ACTIVE_COMPARATOR: Early handwashing station + education
This arm will include 5 randomly selected schools that will have had handwashing stations built after the baseline observation (Phase I), and will receive a Hand hygiene education-based program, after Phase II data collection is complete.
|
A handwashing station will be a dedicated location for handwashing in each selected school and will include:
The early handwashing stations will be constructed in weeks 1 and 2 of the study, after the baseline observations (Phase I) are complete. Hand hygiene education-based program: the hygiene promotion element will include a one month program of handwashing education involving weekly facilitator led sessions. Each session will be about 30-45 minutes long, and will cover the following topics:
The Hand hygiene education-based program will begin at the beginning of weeks 4 and 5, after Phase II data collection is complete in each randomly assigned education school. |
|
ACTIVE_COMPARATOR: Late handwashing station + education
This arm will include 5 randomly selected schools that will have had handwashing stations built after Phase II data collection is complete, when the Hand hygiene education-based program will commence.
|
A handwashing station will be a dedicated location for handwashing in each selected school and will include:
The late handwashing stations construction will begin after Phase 2 data collection has been finished at the end of week 3. Hand hygiene education-based program: the hygiene promotion element will include a one month program of handwashing education involving weekly facilitator led sessions. Each session will be about 30-45 minutes long, and will cover the following topics:
The Hand hygiene education-based program will begin at the beginning of weeks 4 and 5, after Phase II data collection is complete in each randomly assigned education school. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in the probability of handwashing with soap after a toileting event among students receiving nudge intervention compared to that of students in hygiene education group
Time Frame: Weeks 6-7, Week 12, Weeks 18-19, Weeks 24-25
|
Students will be randomized into Nudge intervention or Hygiene Education intervention at the completion of data collection in week 6, and the change in probability, or prevalence ratio, will be assessed over time, with measures at weeks 4-5, weeks 6-7, week 12, weeks 18-19 and weeks 24-25, comparing the probability of handwashing of nudge students post-toileting event to that of hygiene education students post-toileting event, measured using camera observations of the handwashing station outside of the latrine area.
|
Weeks 6-7, Week 12, Weeks 18-19, Weeks 24-25
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in the probability of handwashing with soap after a toileting event among students who received the early handwashing station intervention compared to students who received the late handwashing station intervention
Time Frame: Weeks 2-3, Weeks 4-5
|
Students will be randomized into early handwashing station intervention (built in weeks 1-2) or late handwashing station intervention (built in weeks 3 and 4), and the change in probability, or prevalence ratio, will be assessed at week 2-3 and week 4-5, comparing the probability of handwashing of the early handwashing station students post-toileting event to that of the late handwashing station students post-toileting event, measured using camera observations of the handwashing station outside of the latrine area.
|
Weeks 2-3, Weeks 4-5
|
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Change in the probability of handwashing with soap after a toileting event within the nudge intervention group, comparing students in the early handwashing station intervention to students in the late handwashing station intervention
Time Frame: Weeks 4-5, Weeks 6-7, Week 12, Weeks 18-19, Weeks 24-25
|
In order to assess if the timing of the handwashing station building influences handwashing, the change in probability, or prevalence ratio, will be assessed over time, with observations at weeks 4-5, weeks 6-7, week 12, weeks 18-19 and weeks 24-25 within the Nudge group, comparing the probability of handwashing among students who received the early handwashing station (built in weeks 1 and 2) to the probability of handwashing among those students who received the late handwashing stations (built in weeks 3 and 4), measured using camera observations of the handwashing station outside of the latrine area.
|
Weeks 4-5, Weeks 6-7, Week 12, Weeks 18-19, Weeks 24-25
|
|
Change in the probability of handwashing with soap after a toileting event within the hygiene education intervention group, comparing students in the early handwashing station intervention to students in the late handwashing station intervention
Time Frame: Weeks 4-5, Weeks 6-7, Week 12, Weeks 18-19, Weeks 24-25
|
In order to assess if the timing of the handwashing station building influences handwashing, the change in probability, or prevalence ratio, will be assessed over time, with observations at weeks 4-5, weeks 6-7, week 12, weeks 18-19 and weeks 24-25 within the Hygiene Education group, comparing the probability of handwashing among students who received the early handwashing station (built in weeks 1 and 2) to the probability of handwashing among those students who received the late handwashing stations (built in weeks 3 and 4), measured using camera observations of the handwashing station outside of the latrine area.
|
Weeks 4-5, Weeks 6-7, Week 12, Weeks 18-19, Weeks 24-25
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Kamal Hossain, Save the Children
- Study Director: Mohini Venkatesh, Save the Children
- Study Director: Pavani K Ram, MD, University at Buffalo
- Study Director: Elise N Grover, MSPH, University of Oklahoma
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 6304 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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