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DiarrheaNCT02424812

Evaluation Of The Unilever Lifebuoy School-Based Handwashing Campaign (School Of 5) In Rural Bihar, India

A study testing Lifebuoy School of Five Handwashing Intervention in people with Diarrhea, run by London School of Hygiene and Tropical Medicine at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Diarrhea
What is being tested?
Lifebuoy School of Five Handwashing Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,628 participants
Where
1 siteIndia
Study dates
Feb 2016to 27 Feb 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • none of the above

Trial locations and contacts

1 site in 1 country.

India1 site
  • KAAPRO

    Patna, Bihar

Other trials in India

About this study

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.

Read the detailed description

The Unilever Lifebuoy School-Based Handwashing campaign ("School of 5") aims at raising hygiene awareness and the importance of handwashing with soap among school children and their parents attending rural Indian schools. The campaign is funded by Unilever Ltd India and Children's Investment Fund Foundation (CIFF). CIFF is paying for this evaluation. The aim of this trial is to evaluate the effect of the Unilever Lifebuoy School-Based Handwashing campaign on 1) handwashing behaviour in school aged children and their mothers/carers (primary outcome), 2) psychosocial indicators of hygiene behaviour in the target population; 3) on diarrhoea in children under 5 years of age living in families with school children attending intervention schools.

We will conduct a cluster randomised trial (CRT) of 320 villages in one district of Bihar State, India. The unit of treatment allocation will be villages, as some villages have more than one school. We expect selection of 320 villages to result in about 400 eligible schools. Schools are eligible to receive the intervention if they have more than 150 children enrolled in the school register. 160 villages will be randomised to receive the intervention at the beginning of the study before assessing the study outcomes ("intervention schools/villages") and 160 will be randomised to receive the intervention at the end of the programme after completing all research activities ("control schools/villages").

The research activities will be done in four phases. Phase 1 will be a conducted before the intervention within a subset of 20 villages of the total population of randomised study villages (10 intervention - 10 control), randomly selected from two blocks (administrative units at sub-district level) in the district. The aim is to obtain a baseline measurement of handwashing habits using the sticker diary methodology developed by Unilever.

In Phase 2 we will evaluate the impact of the intervention on handwashing behaviour in the target population, i.e. handwashing at specified times in school children and their mothers. Hygiene behaviour will be measured by two methods: 1) sticker diary (measured by revisiting the Phase 1 villages and households); 2) Direct structured observation of handwashing. For the structured observation study we will recruit households from 12 control and 12 intervention villages that are different from the phase 1 villages. We will further evaluate the early effect of the intervention on knowledge of intervention content, attitudes and motivations related to hygiene behaviour and handwashing in school children and their parents. The results of phase 2 will tell us whether the intervention changed the target behaviours as a basis for achieving any health impact. Based on the results of Phase 2 we will make the following decisions for Phase 3 in collaboration with the co-funder (CIFF): 1) if Phase 2 indicates a marked behaviour change with the potential to impact on health, we will proceed with the measurement of the main health outcomes in all study villages. 2) If there is no major behaviour change potentially impacting on health, we will focus on the process documentation, qualitative research and with the aim of obtaining knowledge for improving the current campaign and increase our learning from the programme.

Upon completion of Phase 3, or phase 2 if no phase 3 is conducted, we will conduct a final handwashing behaviour change assessment (Phase 4) in the study area in the phase 2 villages, and in a further district in Bihar to assess the impact of the intervention on handwashing behaviour across a wider area, and the sustainability of the changes. This phase will use the same methods as in Phase 2, and also include an economic evaluation of the programme.

Conditions
Diarrhea
Being tested
Lifebuoy School of Five Handwashing Intervention
Keywords
handwashing, behavior
Medical subject headings
Diarrhea, Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lifebuoy School of Five Handwashing InterventionBehavioural

Study groups in NCT02424812
Study groupRoleWhat they receive
InterventionExperimentalschool based handwashing education programme
Receives: Behavioral: Lifebuoy School of Five Handwashing Intervention
ControlNo interventionno intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3 months after intervention, single contact

Secondary outcomes (1)
  1. Diarrhoea

    Diarrhoea will be assessed as the 2 week period prevalence of diarrhoea in children under 5 years. Diarrhoea will be defined as 3 or more loose stools on at least one day at any time during the past 2 weeks if the loose stools were associated with general signs of being unwell: unwilling to play, abdominal pain, vomiting, treatment sought. The symptoms will be assessed by the use of questionnaires administered to the primary carer of the child.

    Measured: 6 months to 9 months post intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2015 (estimated)
  2. Study startFeb 2016
  3. Primary completion10 Nov 2016
  4. Study completion27 Feb 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
2,628 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02424812
Sponsor's protocol ID
ciff001
Status last verified
Mar 2017
First submitted
20 Apr 2015
Last updated
8 Mar 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Lifebuoy School of Five Handwashing Intervention in people with Diarrhea, run by London School of Hygiene and Tropical Medicine at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Handwashing with soap (time frame: 3 months after intervention, single contact). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2017.

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