HygieneNCT04929860
Intervention to Change Handwashing Behaviour in India
A study testing social marketing campaign in people with Hygiene and Handwashing, run by London School of Hygiene and Tropical Medicine at 1 site in India.
Trial summary
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hygiene, Handwashing, Behaviour
- What is being tested?
- social marketing campaign
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,747 participants
- Where
- 1 siteIndia
- Study dates
- Jul 2011to Apr 2012
- 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
- households with children of primary school age or younger
Who cannot join
- households without school-aged or younger children
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Hygiene, Handwashing, Behaviour
- Being tested
- social marketing campaign
- Keywords
- diarrhoea, handwashing, hygiene
- Medical subject headings
- Behavior, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
social marketing campaignBehavioural
social marketing campaign delivered over 4 weeks in 4 separate sessions
| Study group | Role | What they receive |
|---|---|---|
| handwashing | Active comparator | 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 Receives: Behavioral: social marketing campaign |
| control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Handwashing with soap directly observed
cross sectional survey using direct observation of householders by local study staff
Measured: one months after interventions is terminated
Secondary outcomes (1)
Soap use measured by motion detectors embedded in soap bars
Measured: soap movements over one week one month after assessment of the primary outcome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study startJul 2011
- Primary completionFeb 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HygieneStudies 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
- None (open label)
- Enrolment
- 1,747 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- St. John's Research Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04929860
- Sponsor's protocol ID
- WT-001
- Status last verified
- Jun 2011
- First submitted
- 10 Jun 2021
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cluster Randomised Trial to Evaluate and Intervention to Change Handwashing Behaviour in Rural Indian Households
- ClinicalTrials.gov ID
- NCT04929860
- Acronym / sponsor ID
- WT-001
- Conditions
- Hygiene, Handwashing, Behaviour
- Keywords
- diarrhoea, handwashing, hygiene
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,747 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- St. John's Research Institute
- Study start
- Jul 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 18 Jun 2021 (actual)
- 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 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| handwashing | Active comparator | Behavioral: social marketing campaignThis 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 |
| control | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- households with children of primary school age or younger
Key exclusion criteria (1 listed)
- households without school-aged or younger children
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 |
|---|---|---|
| social marketing campaignsocial marketing campaign delivered over 4 weeks in 4 separate sessions | Behavioural | handwashing |
Primary outcome
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
1 secondary outcome
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
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 18 Jun 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing social marketing campaign in people with Hygiene and Handwashing, 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 1 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 18 Jun 2021. 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 directly observed (time frame: one months after interventions is terminated). 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 18 Jun 2021.