Evaluation of the Impact of a Personal and Domestic Hygiene Intervention on Lead Exposure in a Community Close to a Mine Dump

April 1, 2022 updated by: Charlotte Mokoatle, University of Johannesburg
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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

576

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 1863
        • Snake Park, Soweto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 5 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children between the ages of one and five years

Exclusion Criteria:

  • Children above 5 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
The group that will receive the intervention to apply
Behavioral: Domestic Hygiene and household hygiene 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.
No Intervention: Control group
The group that will not receive the intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lead exposure level
Time Frame: Three months
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
Three months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reference Lead exposure level
Time Frame: Three months
A reference level of 5.0 μg/dL for public health intervention of exposure to lead
Three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Johannesburg

Collaborators

Medical Research Council, South Africa

Investigators

  • Principal Investigator: Makhutsisa C Mokoatle, Masters, University of Johannesburg
  • Study Director: Vusumuzi Nkosi, PhD, Medical Research Council, South Africa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 14, 2021

Primary Completion (Anticipated)

July 31, 2022

Study Completion (Anticipated)

September 30, 2022

Study Registration Dates

First Submitted

February 18, 2022

First Submitted That Met QC Criteria

February 18, 2022

First Posted (Actual)

March 3, 2022

Study Record Updates

Last Update Posted (Actual)

April 11, 2022

Last Update Submitted That Met QC Criteria

April 1, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mining Intervention Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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