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A randomized trial of a school health curriculum
Last registered on December 16, 2019

Pre-Trial

Trial Information
General Information
Title
A randomized trial of a school health curriculum
RCT ID
AEARCTR-0005182
Initial registration date
December 15, 2019
Last updated
December 16, 2019 10:53 AM EST
Location(s)
Region
Primary Investigator
Affiliation
Haas School of Business
Other Primary Investigator(s)
Additional Trial Information
Status
On going
Start date
2019-08-01
End date
2020-09-30
Secondary IDs
Abstract
Handwashing could prevent over a million children from dying each year. At the same time, tooth decay is
the most common preventable chronic illness. It affects an estimated 60–90% of schoolchildren and nearly
100% of adults worldwide, according to the WHO Global Oral Health Database. Standard health
interventions provide supplies and information, but usually lead to only modest behavior change.
Hygiene Heroes, a partnership of UC Berkeley and IIT Madras, has been developing a health education
program for Tamil Nadu schools since 2014 (http://hygieneheroes.berkeley.edu/). Our curriculum has vivid
activities, engaging stories and simple routines to teach, change norms and increase safe behaviors.
We will run a randomized controlled trial in 200 schools in Taml Nadu. We will implement the curriculum for
handwashing with soap in half the schools and the curriculum for brushing teeth with fluoride toothpaste in
the other half of schools. Our intervention targets students and teachers. It teaches new behaviors and
routines, changes attitudes. We also provide a low-cost soapy bottle that cost only 20% as much as bars
of soap (about $0.04 / student per year).
External Link(s)
Registration Citation
Citation
Levine, David. 2019. "A randomized trial of a school health curriculum." AEA RCT Registry. December 16. https://doi.org/10.1257/rct.5182-1.0.
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Experimental Details
Interventions
Intervention(s)
We will recruit 200 government primary schools. Schools will be in the two target districts, have at least 2 classrooms total teaching grades 2-5. (There can be multi-grade classrooms, but we do not want a school with only one classroom combining all grades 2-5, have as many working taps (at baseline) as there are classrooms grades 2-5, not be too remote.

In schools with multiple classrooms per grade, we will select classes at random.
We may prioritize schools working with a subset of the BRTEs (trainers) in the districts, to reduce
coordination costs with BRTEs
•The training will cover all teachers in the target schools.
oWe will administer informed consent to all teachers at the trainings.
oAll teachers who consent will receive the pre- and post-training surveys.

We will work with the school system to identify all schools in the Kancheepuram and Thiruvallur districts.
These districts are located near the large city of Chennai, in the southern Indian state of Tamil Nadu. They
include urban, peri-urban, town and rural areas.
For the intervention, the teachers will be trained at a standard training with a standard trainer (called a
BRTE). So no recruitment is involved.
At this training we will request informed consent from teachers to fill out a pre-test and post-test.
In the classroom, we will select students at random (described below). We will invite students to a private
part of the school and ask their assent to participate in the study. The assent form is in section

observation at each school
In each school we will do observation in one classroom in each grade 2 through 5. If a school had fewer
than 4 classes in those grades (total), we will observe in all classrooms in those grades. If a school has
multiple classrooms in the same grade, we will ask them to ranked classrooms in order of room numbers
from low to high. Enumerators will consult a random number list we provided to see which classroom to
observe.
Observation will record the number of working taps and the presence of soap near taps or in classrooms.
There is one observation per school at baseline. It will collect no individually identifiable information.
oBaseline data collection of a sample of 4 students per classroom (16 per school) visit.
Enumerators will receive a list of random numbers for each classroom. Teachers already have a
numbered roster for their class. Enumerators will go down the list of random numbers until they identify 4
numbers that match the roster numbers of students present that day. We will do surveys and dental
exams on those four students. We will not retain a copy of the roster or of the student names.
We will explain that students can participate in the educational program even if they decline to participate
in the survey. Students can return to class if they do not want to participate in data collection. If necessary,
the enumerator will use the next random number on their list to choose the next student present that day.
A baseline survey for students (attached). Enumerators will interview students. Data collection will be
on phones or tablets using ODK (open data kit).
A trained dental resident from Saveetha Dental College will do a baseline measure of plaque on teeth,
gingivitis (mild gum disease), missing teeth, fillings and cavities. The dental interns will use observation
with a dental mirror.
This exam will use dental disclosing tablets. These tablets turn pink in the presence of plaque. The pink
wears off in a couple of hours. We will help the students brush teeth well, so the pink should be mostly wears off in a couple of hours. We will help the students brush teeth well, so the pink should be mostly
eliminated before they return to their classroom. Disclosing tablets have been given to millions of children
to help them learn to brush teeth well. They have no known risks.
The resident will record data on the standard WHO form for recording dental health, supplemented slightly
(attached).
The dental resident will ask students to brush without a paste. Residents will classify as student as
positive for gingivitis If there is visible bleeding after 30 seconds.
If the dental exam finds a serious problem, the dental resident will write a brief note for the parents of the
student noting the problem and suggesting a follow-up visit with a dental professional.
Note: The surveys and dental exam are identical across study arms, so several students per classroom in
the handwashing arm will receive the dental exam.
*********************
Randomization of schools
*********************
The UC Berkeley team will generate all random sequences using Excel.
After collecting baseline data, we will stratify all schools by district, school size and by urban/rural. Within
each strata we will do 50:50 randomization of schools into the hygiene arm or the dental health arm.
No individually identifiable information from students and/or teachers be collected and/or used for
purposes of randomization.
*********************
Intervention
*********************
In each arm, the intervention will include
•Train BRTEs (trainers who work for the school system) and distributing teaching materials. A dental
professional will be present when training BRTEs on the dental curriculum. We will observe BRTEs doing
a practice training and provide feedback. (BRTEs will not do dental exams.)
•BRTEs train principals and teachers and distributing teaching materials
•Teachers teach class
In the handwashing arm we will also
•Provide soapy bottles
•Provide refills of soap
In the dental health arm we will also provide each student a toothbrush.
The content of the curriculum will cover
•Handwashing arm: How to wash hands with soap. The importance of handwashing with soap after using
the toilet and before eating. How to wash hands. Daily routines for handwashing before lunch.
•Dental hygiene arm: How to brush teeth. The importance of brushing teeth with a fluoride toothpaste twice a day

The importance of limiting sugary foods and sodas.
In each arm, teaches will teach content that includes:
•vivid demonstrations
•illustrated stories
•class participations stories
•students creating reminder posters to bring home
•letters home to help teach parents about the importance of this behavior
•a star chart in the classroom to track students' daily behavior change (for several weeks)
•Teacher training
oWe will explain the purpose of the study
oWe will take written informed consent from teachers, (attached). We will read the informed consent in
Tamil. We will explain that they can participate in the training even if they decline to participate in the data
collection
oWe will administer a baseline survey of teachers (attached). Teachers will fill out a short written
survey. Content will vary slightly by study arm.
oThe BRTE will carry out the training
oWe will administer a follow-up survey of teachers (attached)
Teaching will occur during normal class time. Students who decline to participation in data collection will
still be part of the class for the instruction on handwashing or dental hygiene.
The teaching will take up to 5 40-minute periods of instruction. There will also be star charts lasting 3
weeks for students to record their healthy behaviors (either handwashing with soap or brushing teeth)

*********************
Follow-up data collection
*********************
•Follow-up observation at each school (attached ) lasting up to 8 months
oIn the handwashing arm: Repeated at each soap refill visit, so approximately every 3 weeks.
oIn the dental hygiene arm: Repeated each 6 weeks.
We will observe
* the presence of soap and the number of working taps.
* For the first 2 months of observation: Evidence teachers have taught the curriculum: Letters home have
been returned, star charts are on the walls.
* For the handwashing arm, we will arrive just as lunch begins and see if students are washing hands with
soap before eating. There will be up to 11 brief visits / school.

Observation will include no photos, no videos, and no individually identifiable information.
•Follow-up survey and dental observation of a sample of up to 8 students per classroom for 4 classrooms /
school. The procedure will be identical as the baseline data collection.
The follow-up survey will be repeated 2-3 months and 4-5 months post-intervention.
dental observation will be only 4-5 months post-intervention.

Intervention Start Date
2019-09-01
Intervention End Date
2019-12-01
Primary Outcomes
Primary Outcomes (end points)
Observing handwashing with soap in unannounced visits during the first minutes of lunch period
Presence of plaque in the dental observation.
Primary Outcomes (explanation)
Secondary Outcomes
Secondary Outcomes (end points)
Presence of soap or soapy bottles
Self-reported handwashing with soap after toilet and before eating.
Self-reported brushing teeth frequency and with fluoride toothpaste
Star charts in classroom + knowledge test score
Secondary Outcomes (explanation)
Experimental Design
Experimental Design
We will stratify the 200 schools by district and size and randomize into the handwashing or dental hygiene arms.
Experimental Design Details
Randomization Method
Office computer
Randomization Unit
School
Was the treatment clustered?
Yes
Experiment Characteristics
Sample size: planned number of clusters
200 schools (100 per arm)
Sample size: planned number of observations
4 students per classroom * up to 3 classes per school * 200 schools
Sample size (or number of clusters) by treatment arms
100 schools in the handwashing with soap arm and 100 schools in the dental hygiene arm
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
8 percentage point increase in handwashing with soap before lunch.
IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
University of California, Berkeley CPHS
IRB Approval Date
2019-08-22
IRB Approval Number
2019-05-12187
Post-Trial
Post Trial Information
Study Withdrawal
Intervention
Is the intervention completed?
No
Is data collection complete?
Data Publication
Data Publication
Is public data available?
No
Program Files
Program Files
Reports, Papers & Other Materials
Relevant Paper(s)
REPORTS & OTHER MATERIALS