Effects of Household Concrete Floors on Child Health
Study Details
Study Description
Brief Summary
This randomized trial in rural Bangladesh will measure whether installing concrete floors in households with soil floors reduces child enteric infection. The trial will randomize eligible households to receive concrete household floors or to no intervention and measure effects on child soil-transmitted helminth infection, diarrhea, and other enteric infections. The study will collect longitudinal follow-up measurements when children are aged 6, 12, 18, and 24 months.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Concrete household floor
|
Other: Concrete household floor
Household soil floors will be replaced with concrete floors
|
| No Intervention: Non-intervention
|
Outcome Measures
Primary Outcome Measures
- Child Ascaris lumbricoides infection prevalence [Up to 24 months]
Prevalence of Ascaris lumbricoides infection in birth cohort detected with qPCR at any follow-up measurement through month 24
Secondary Outcome Measures
- Child Necator americanus infection prevalence [Up to 24 months]
Prevalence of Necator americanus infection in birth cohort detected with qPCR at any follow-up measurement through month 24
- Child Trichuris trichiura infection prevalence [Up to 24 months]
Prevalence of Trichuris trichiura infection in birth cohort detected with qPCR at any follow-up measurement through month 24
- Child prevalence of any soil-transmitted helminth infection [Up to 24 months]
Prevalence of Ascaris lumbricoides, Necator americanus, or Trichuris trichiura infection in birth cohort detected with qPCR at any follow-up measurement
- Child diarrhea prevalence [Up to 24 months]
Prevalence of diarrhea is defined as 3 or more loose or watery stools in 24 hours or 1 or more stools with blood in 24 hours at any follow-up measurement. Diarrhea will be based on caregiver-reported symptoms in the birth cohort with 2-day and 7-day recall at any follow-up measurement through month 24
- Child prevalence of other enteric pathogen carriage [Up to 24 months]
Prevalence of other enteric pathogens in stool samples detected using a TaqMan array card in a sub-sample of the birth cohort at any follow-up measurement through month 24
- Percentage of mothers satisfied or very satisfied with their quality of life at 6 months [6 months]
Percentage of mothers satisfied or very satisfied with their quality of life based on a four-point scale (very satisfied, satisfied, somewhat unsatisfied, unsatisfied) measured at the 6 month follow-up visit
- Percentage of mothers satisfied or very satisfied with their quality of life at 24 months [24 months]
Percentage of mothers satisfied or very satisfied with their quality of life based on a four-point scale (very satisfied, satisfied, somewhat unsatisfied, unsatisfied) measured at the 24 month follow-up visit
- Mean maternal stress score at 6 months [6 months]
Mean Perceived Stress Scale score for mothers measured at the 6 month follow-up visit. The scale ranges from 0-40, and higher scores indicate higher perceived stress.
- Mean maternal stress score at 24 months [24 months]
Mean Perceived Stress Scale score for mothers measured at the 24 month follow-up visit. The scale ranges from 0-40, and higher scores indicate higher perceived stress.
- Prevalence of maternal depression at 6 months [6 months]
Prevalence of maternal depression based on a score of 16 or higher using the Center for Epidemiologic Studies Depression scale measured at the 6 month follow-up visit. The scale ranges from 0-60, and higher scores indicate presence of more depression symptoms.
- Prevalence of maternal depression at 24 months [24 months]
Prevalence of maternal depression based on a score of 16 or higher using the Center for Epidemiologic Studies Depression scale measured at the 24 month follow-up visit. The scale ranges from 0-60, and higher scores indicate presence of more depression symptoms.
- Mean maternal depression score at 6 months [6 months]
Mean Center for Epidemiologic Studies Depression scale score for mothers measured at the 6 month follow-up visit. The scale ranges from 0-60, and higher scores indicate presence of more depression symptoms.
- Mean maternal depression score at 24 months [24 months]
Mean Center for Epidemiologic Studies Depression scale score for mothers measured at the 24 month follow-up visit. The scale ranges from 0-60, and higher scores indicate presence of more depression symptoms.
Other Outcome Measures
- Ascaris lumbricoides prevalence in household floor samples [Up to 24 months]
Prevalence of Ascaris lumbricoides detected in household floor swabs with qPCR at any follow-up measurement through month 24
- Trichuris trichiura prevalence in household floor samples [Up to 24 months]
Prevalence of Trichuris trichiura detected in household floor swabs with qPCR at any follow-up measurement through month 24
- Any soil-transmitted helminth prevalence in household floor samples [Up to 24 months]
Prevalence of Ascaris lumbricoides or Trichuris trichiura detected in household floor swabs with qPCR at any follow-up measurement through month 24
- Culturable E. coli prevalence in household floor samples [Up to 24 months]
Prevalence of E. coli in household floor swabs detected with IDEXX at any follow-up measurement in a sub-sample of households at any follow-up measurement through month 24
- Prevalence of other enteric pathogen carriage in household floor samples [Up to 24 months]
Prevalence of other enteric pathogens in household floor samples detected using a TaqMan array card in a sub-sample of households at any follow-up measurement through month 24
- Frequency of child soil contact [Up to 24 months]
Mean number of child soil contact events per hour measured using video observations in a sub-sample of the birth cohort at each follow-up measurement through month 24
- Frequency of child soil ingestion [Up to 24 months]
Mean number of child soil ingestion events per hour measured using video observations in a sub-sample of the birth cohort at each follow-up measurement through month 24
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Residence in Comilla district in Bangladesh
-
No plan to relocate in the next 2 years
-
Reside in home with floors made entirely of soil
-
Pregnant women in her second or third trimester resides in the home at the time of enrollment
Exclusion Criteria:
- Home is not strictly residential (e.g., includes a business)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | International Centre for Diarrhoeal Disease Research, Bangladesh | Dhaka | Bangladesh |
Sponsors and Collaborators
- Stanford University
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- International Centre for Diarrhoeal Disease Research, Bangladesh
- North Carolina State University
Investigators
- Principal Investigator: Jade Benjamin-Chung, PhD MPH, Stanford University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 63990