Hygiene Clinical Trial
Official title:
A Cluster Randomised Trial to Evaluate and Intervention to Change Handwashing Behaviour in Rural Indian Households
NCT number | NCT04929860 |
Other study ID # | WT-001 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 2011 |
Est. completion date | April 2012 |
Verified date | June 2011 |
Source | London School of Hygiene and Tropical Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1747 |
Est. completion date | April 2012 |
Est. primary completion date | February 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - households with children of primary school age or younger Exclusion Criteria: - households without school-aged or younger children |
Country | Name | City | State |
---|---|---|---|
India | St. John's Research Institute | Palamener | Andra Pradesh |
Lead Sponsor | Collaborator |
---|---|
London School of Hygiene and Tropical Medicine | St. John's Research Institute |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Handwashing with soap directly observed | cross sectional survey using direct observation of householders by local study staff | one months after interventions is terminated | |
Secondary | Soap use measured by motion detectors embedded in soap bars | soap movements over one week one month after assessment of the primary outcome |
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