Effect of a Pilot Group Hand-washing Program on Handwashing Behaviors Among Elementary School Children in Assam

February 27, 2020 updated by: Network for Engineering and Economics Research and Management

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
823

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Maharashtra
      • Mumbai, Maharashtra, India, 400014
        • NEERMAN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

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).

Description

Inclusion Criteria:

  • Should be present in the school on the day of interview/survey

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
DHaAL Intervention
The group receives standard Ailment-free Life (DHaAL) DHaAL intervention
Behavioral: DHaAL Intervention

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 Intervention
This group received the standard DHaAL intervention and additional support under another UNICEF program named Child Friendly School System (CFSS).
Behavioral: DHaAL Intervention

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.

Behavioral: DHaAL + CFSS Intervention
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.
Control
This group receive the standard / business-as-usual support from the Education Department, but does not receive DHaAL or CFSS Interventions.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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)
On the day of interview (~12-24 months after the external support under DHaAL ceased)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
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)
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)
This is an indirect or spill over effect of the intervention
On the day of interview (~12-24 months after the external support under DHaAL ceased)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Network for Engineering and Economics Research and Management

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
UNICEF

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sumeet Patil, Network for Engineering and Economics Research and Management

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 27, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 30, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 2, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2016/06/UNICEF01

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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