Intervention to Change Handwashing Behaviour in India

June 16, 2021 updated by: London School of Hygiene and Tropical Medicine

A Cluster Randomised Trial to Evaluate and Intervention to Change Handwashing Behaviour in Rural Indian Households

The research will test the hypothesis that a scalable behaviour change intervention can improve hand-washing practices in rural Indian households. The intervention will be designed using a social marketing approach and will use motivational messages targeting key audiences rather than educational messages about germs and disease which previously have been found ineffective. The intervention will be designed for low-cost, scaleable delivery using a series of visits to target villages by a two-person team on a motorbike. The key goal of the study is to determine the effectiveness of a scaleable, social marketing intervention to promote hand-washing with soap.

The study will take the form of a cluster-randomized, controlled intervention trial. Villages will be randomized to receive either the intervention or no intervention. The primary outcome measure will be the proportion of key events (defecation, faecal contact or food handling) accompanied by hand-washing with soap. These data will be collected by direct observation. A secondary outcome measure will be the number of soap movement episodes. These data will be collected in a sub-sample of households by using electronic motion detectors embedded in bars of soap. Additionally, questionnaires will be used to collect data on social norms, self-reported soap use and habitual soap use. All data will be collected pre and post-intervention.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1747

Phase

  • Not Applicable

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
    • Andra Pradesh
      • Palamener, Andra Pradesh, India
        • St. John's Research Institute

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

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • households with children of primary school age or younger

Exclusion Criteria:

  • households without school-aged or younger children

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control
Active Comparator: handwashing
This arm receives a scalable social marketing campaign using innovative behaviour change approaches to improve handwashing. The intervention is delivered by a commercial social marketing business unrelated to the investigating organisations
Behavioral: social marketing campaign
social marketing campaign delivered over 4 weeks in 4 separate sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Handwashing with soap directly observed
Time Frame: one months after interventions is terminated
cross sectional survey using direct observation of householders by local study staff
one months after interventions is terminated

Secondary Outcome Measures

Outcome Measure
Time Frame
Soap use measured by motion detectors embedded in soap bars
Time Frame: soap movements over one week one month after assessment of the primary outcome
soap movements over one week one month after assessment of the primary outcome

Collaborators and Investigators

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

Sponsor

London School of Hygiene and Tropical Medicine

Collaborators

St. John's Research Institute

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

July 1, 2011

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

June 10, 2021

First Submitted That Met QC Criteria

June 16, 2021

First Posted (Actual)

June 18, 2021

Study Record Updates

Last Update Posted (Actual)

June 18, 2021

Last Update Submitted That Met QC Criteria

June 16, 2021

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • WT-001

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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