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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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 group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | school based handwashing education programme Receives: Behavioral: Lifebuoy School of Five Handwashing Intervention |
| Control | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
- First posted23 Apr 2015 (estimated)
- Study startFeb 2016
- Primary completion10 Nov 2016
- Study completion27 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Hindustan Unilever Ltd.
- Responsible party
- Sponsor
- Investigators
- Wolf-Peter Schmidt, PhD, MD, Principal investigator, London School of Hygiene and Tropical Medicine
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of The Unilever Lifebuoy School-Based Handwashing Campaign (School Of 5) In Rural Bihar, India
- ClinicalTrials.gov ID
- NCT02424812
- Acronym / sponsor ID
- ciff001
- Conditions
- Diarrhea
- Keywords
- handwashing, behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,628 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Hindustan Unilever Ltd.
- Study start
- Feb 2016 (actual)
- Primary completion
- 10 Nov 2016 (actual)
- Study completion
- 27 Feb 2017 (actual)
- First posted
- 23 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Lifebuoy School of Five Handwashing Interventionschool based handwashing education programme |
| Control | No intervention | –no intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- none of the above
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifebuoy School of Five Handwashing Intervention | Behavioural | Intervention |
Primary outcome
Handwashing with soap
Time frame: 3 months after intervention, single contact
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.
1 secondary outcome
Diarrhoea
Time frame: 6 months to 9 months post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wolf-Peter Schmidt, PhD, MD principal investigator
London School of Hygiene and Tropical Medicine
1 site in 1 country: see every site and its status.
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.