NCT02424812

Brief Summary

The effect of large scale handwashing and hygiene promotion campaigns on handwashing behaviour, diarrhoea and respiratory infections is not known. While Intensive small scale interventions have achieved improvements in handwashing behaviour and reductions in diarrhoea and respiratory infections, it is not clear whether realistic and scalable interventions delivered across large areas achieve effects large enough to be of public health interest. The Unilever "School of 5" Lifebuoy campaign is such a scalable intervention that is being rolled out across the state of Bihar during 2015 to 2017. The proposed study aims at evaluation the effect of this campaign on handwashing behaviour in school aged children and their mothers, and on diarrhoea and respiratory infections in the same children and their younger siblings.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,628

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 23, 2015

Completed
9 months until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2017

Completed
Last Updated

March 8, 2017

Status Verified

March 1, 2017

Enrollment Period

9 months

First QC Date

April 20, 2015

Last Update Submit

March 7, 2017

Conditions

Keywords

handwashingbehavior

Outcome Measures

Primary Outcomes (1)

  • Handwashing with soap

    handwashing behaviour will be assessed by direct (structured) observation by a female field observer. Specifically, observers will identify 3 occasions of handwashing (before eating, after toilet use, and after child care). The primary outcome of the study will be the proportion of these observed occasions at which the subject washed hands with soap. The outcome will be observed in school children and adult household members.

    3 months after intervention, single contact

Secondary Outcomes (1)

  • Diarrhoea

    6 months to 9 months post intervention

Study Arms (2)

Intervention

EXPERIMENTAL

school based handwashing education programme

Behavioral: Lifebuoy School of Five Handwashing Intervention

Control

NO INTERVENTION

no intervention

Interventions

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Enrolled households have a child that attends a school in the village that has more than 150 children on the school register.
  • Enrolled households further have a child under 5 years.

You may not qualify if:

  • none of the above

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KAAPRO

Patna, Bihar, India

Location

MeSH Terms

Conditions

DiarrheaBehavior

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Wolf-Peter Schmidt, PhD, MD

    London School of Hygiene and Tropical Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2015

First Posted

April 23, 2015

Study Start

February 1, 2016

Primary Completion

November 10, 2016

Study Completion

February 27, 2017

Last Updated

March 8, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations