Evaluation of the Impact of a Personal and Domestic Hygiene Intervention on Lead Exposure in a Community Close to a Mine Dump
Primary Purpose
Lead Poisoning, Lead Poison Children
Status
Enrolling by invitation
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
Domestic Hygiene and household hygiene Intervention
Sponsored by
About this trial
This is an interventional prevention trial for Lead Poisoning focused on measuring Lead, Lead exposure, Mine Dumps
Eligibility Criteria
Inclusion Criteria:
- Children between the ages of one and five years
Exclusion Criteria:
- Children above 5 years
Sites / Locations
- Snake Park, Soweto
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Control group
Arm Description
The group that will receive the intervention to apply
The group that will not receive the intervention
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Reference Lead exposure level
A reference level of 5.0 μg/dL for public health intervention of exposure to lead
Full Information
NCT ID
NCT05265572
First Posted
February 18, 2022
Last Updated
April 1, 2022
Sponsor
University of Johannesburg
Collaborators
Medical Research Council, South Africa
1. Study Identification
Unique Protocol Identification Number
NCT05265572
Brief Title
Evaluation of the Impact of a Personal and Domestic Hygiene Intervention on Lead Exposure in a Community Close to a Mine Dump
Official Title
Evaluation of the Impact of a Personal and Domestic Hygiene Intervention on Lead Exposure in a Community Close to a Mine Dump
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 14, 2021 (Actual)
Primary Completion Date
July 31, 2022 (Anticipated)
Study Completion Date
September 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Johannesburg
Collaborators
Medical Research Council, South Africa
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lead Poisoning, Lead Poison Children
Keywords
Lead, Lead exposure, Mine Dumps
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are divided into two groups and one group is assigned to one household hygiene and an educational intervention which they apply and the impact of the intervention on lead exposure is assessed and the other group has no intervention.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
576 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
The group that will receive the intervention to apply
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The group that will not receive the intervention
Intervention Type
Behavioral
Intervention Name(s)
Domestic Hygiene and household hygiene Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Lead exposure level
Description
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
Secondary Outcome Measure Information:
Title
Reference Lead exposure level
Description
A reference level of 5.0 μg/dL for public health intervention of exposure to lead
Time Frame
Three months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Children between the ages of one and five years
Exclusion Criteria:
Children above 5 years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Makhutsisa C Mokoatle, Masters
Organizational Affiliation
University of Johannesburg
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vusumuzi Nkosi, PhD
Organizational Affiliation
Medical Research Council, South Africa
Official's Role
Study Director
Facility Information:
Facility Name
Snake Park, Soweto
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
1863
Country
South Africa
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All collected IDP to be shared
IPD Sharing Time Frame
Through out the duration of the study up to a period of five years
IPD Sharing Access Criteria
Only the research team will access IPD for capturing and analysis of covariance and descriptive statistics.
Citations:
PubMed Identifier
35658916
Citation
Mokoatle C, Mathee A, Street R, Nkosi V. A study protocol to evaluate the impact of a personal and domestic hygiene intervention on lead exposure in a community next to a mine dump. BMC Public Health. 2022 Jun 4;22(1):1123. doi: 10.1186/s12889-022-13439-8.
Results Reference
derived
Learn more about this trial
Evaluation of the Impact of a Personal and Domestic Hygiene Intervention on Lead Exposure in a Community Close to a Mine Dump
We'll reach out to this number within 24 hrs