An interventional study of Domestic Hygiene and household hygiene Intervention in Lead Poisoning and Lead Poison Children, sponsored by University of Johannesburg. Status unknown at 1 site in South Africa. Open to participants aged 1 Year to 5 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-11.
Sponsored by University of Johannesburg · Not applicable, Interventional, and Prevention
The study evaluates the impact of a personal and domestic hygiene intervention on exposure to lead in a community close to a mine dump. A before and after intervention study will be conducted in a selected area to determine lead exposure levels and the reduction or not after application of the intervention.
A before and after intervention study will be conducted with a control and intervention group, where data will be collected at the household (through questionnaire based interviews, floor and/or windowsill samples and soil samples collection) and individual level (through hand dust wipe sample collection). In phase one, both the control and intervention group will be interviewed, household floor and/or windowsill dust wipes will be taken, yard soil sample collected and hand dust wipe samples will be taken from children in participating households. After baseline data collection, participants will be allocated into either intervention or control group. The intervention group will participate in the domestic hygiene demonstration and educational discussion.
27 studies on the registry are indexed under Lead Poisoning; 2 are open to participants now.
This study's planned enrollment of 576 is above the median of 175 across 11 interventional studies indexed under Lead Poisoning.
Browse Lead Poisoning studies →University of Johannesburg is the lead sponsor of 17 studies on the registry; none are open to participants now.
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Exclusion Criteria:
The group that will receive the intervention to apply
Behavioral: Domestic Hygiene and household hygiene Intervention
The group that will not receive the intervention
A demonstration on the domestic hygiene intervention will be conducted where participants will be guided on optimal cleaning of windowsills, floors and other surfaces with water and detergent, and advised on appropriate method of cleaning. Participants will be provided with a package of cleaning materials (mop, bucket, detergent, hand wash liquid soap and cloth for wet dusting) which will be used during the demonstration, and retained by participants to facilitate sustainability of the intervention during and after the study. Participants will be further engaged in an educational discussion, with the aid of a specially designed educational pamphlet containing information about health effects potentially associated with dust lead exposure from mine dumps and the personal hygiene and domestic hygiene steps that may be followed to reduce dust lead exposure.
Lead exposure level
To detect a mean difference in change from baseline to follow-up of -0.5 μg/dL between the control and experimental group, with common standard deviation of 2 μg/dL
Time frame: Three months
Reference Lead exposure level
A reference level of 5.0 μg/dL for public health intervention of exposure to lead
Time frame: Three months
Plan to share: Yes — All collected IDP to be shared
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Through out the duration of the study up to a period of five years
Access criteria: Only the research team will access IPD for capturing and analysis of covariance and descriptive statistics.
Started Sep 2021 (actual). Primary completion is estimated for Jul 2022, 10 months after the start.
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This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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University of Johannesburg