NCT05265572

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
576

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 14, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 3, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

April 11, 2022

Status Verified

April 1, 2022

Enrollment Period

11 months

First QC Date

February 18, 2022

Last Update Submit

April 1, 2022

Conditions

Lead PoisoningLead Poison Children

Keywords

LeadLead exposureMine Dumps

Outcome Measures

Primary Outcomes (1)

  • 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

    Three months

Secondary Outcomes (1)

  • Reference Lead exposure level

    Three months

Study Arms (2)

Intervention group

EXPERIMENTAL

The group that will receive the intervention to apply

Behavioral: Domestic Hygiene and household hygiene Intervention

Control group

NO INTERVENTION

The group that will not receive the intervention

Interventions

Domestic Hygiene and household hygiene InterventionBEHAVIORAL

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.

Intervention group

Eligibility Criteria

Age1 Year - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children between the ages of one and five years

You may not qualify if:

  • Children above 5 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Snake Park, Soweto

Johannesburg, Gauteng, 1863, South Africa

Location

Related Publications (1)

  • 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.

    PMID: 35658916DERIVED

MeSH Terms

Conditions

Lead Poisoning

Condition Hierarchy (Ancestors)

Heavy Metal PoisoningPoisoningChemically-Induced Disorders

Study Officials

  • Makhutsisa C Mokoatle, Masters

    University of Johannesburg

    PRINCIPAL INVESTIGATOR

  • Vusumuzi Nkosi, PhD

    Medical Research Council, South Africa

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 18, 2022

First Posted

March 3, 2022

Study Start

September 14, 2021

Primary Completion

July 31, 2022

Study Completion

September 30, 2022

Last Updated

April 11, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will share

All collected IDP to be shared

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, 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.

Locations

ZA(1)