A Study to Assess the Efficacy of Public Health Campaigns in Reducing Lead Exposure

June 2, 2026 updated by: International Health Strategies LLC

This clinical trial aims to evaluate the effectiveness of targeted public health campaigns in reducing lead exposure among adults living in urban communities with known environmental lead hazards. Lead exposure remains a significant public health concern, particularly in older urban neighborhoods with aging infrastructure and legacy contamination. Despite existing regulations and remediation efforts, many communities continue to experience elevated blood lead levels, especially among vulnerable populations.

The study will compare the impact of an intensive, multi-modal public health campaign-featuring community workshops, educational materials, and home intervention resources-against standard municipal information dissemination. By assessing changes in blood lead levels and lead-related knowledge, attitudes, and behaviors over a 12-month period, the trial seeks to determine whether enhanced public health outreach can more effectively reduce lead exposure and promote safer practices. The findings will inform future strategies for community-based environmental health interventions.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Lead exposure is a persistent environmental health issue, particularly in urban areas with older housing stock, deteriorating paint, and legacy industrial contamination. Chronic lead exposure, even at low levels, has been associated with neurodevelopmental deficits in children and cardiovascular, renal, and cognitive effects in adults. Despite regulatory progress, disparities in lead exposure persist, often affecting low-income and minority communities.

Traditional public health approaches have relied on passive dissemination of information via municipal websites, pamphlets, and occasional community events. However, evidence suggests that more intensive, community-engaged interventions may be necessary to change behaviors and reduce environmental risks. This study is designed to rigorously assess the efficacy of a comprehensive public health campaign compared to standard information dissemination in reducing lead exposure.

The trial will enroll households from urban neighborhoods identified through environmental surveillance as having elevated lead risks. Eligible participants will be randomized to either the intensive campaign arm or the standard information arm. The intensive campaign will include a series of interactive community workshops, distribution of tailored educational materials, provision of lead-safe cleaning kits, and access to home visits by trained health educators. The control group will receive the standard municipal information package currently in use.

Primary outcomes will include changes in blood lead levels among index participants at baseline and after 12 months. Secondary outcomes will assess changes in lead-related knowledge, adoption of lead-safe practices, and environmental lead measurements in the home. The study will also monitor the incidence of new cases of elevated blood lead and assess participant satisfaction with the interventions.

Data will be collected through home visits, validated questionnaires, and laboratory testing. The trial will use a parallel-group, randomized controlled design with community-level randomization to minimize contamination. Results will inform policymakers and public health practitioners regarding the value of intensive, community-based approaches for environmental hazard reduction.

Study Type

Interventional

Enrollment (Estimated)

400

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 Contact

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Philadelphia City Center
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Resident of selected urban neighborhoods with documented environmental lead risk
  • Household includes at least one adult aged 18-75 years willing to participate
  • Willing to provide informed consent
  • Willing to allow home visits and blood sampling
  • Able to understand study procedures and interventions

Exclusion Criteria:

  • Planning to relocate from the area within the next 12 months
  • Household member with a known diagnosis of severe anemia or bleeding disorder
  • Participation in another intervention study targeting lead exposure in the past 12 months
  • Inability or unwillingness to comply with study procedures
  • Household with known ongoing lead remediation efforts during the study period
  • Pregnant women (due to additional ethical considerations for blood sampling)

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: Intensive Public Health Campaign
Participants receive an intensive, multi-modal public health campaign including workshops, educational materials, lead-safe cleaning kits, and home visits by health educators.
Behavioral: Intensive Public Health Campaign
A comprehensive intervention including: (1) three interactive community workshops on lead risks and prevention, (2) distribution of tailored educational materials, (3) provision of lead-safe cleaning kits (HEPA vacuums, cleaning supplies), and (4) two home visits by trained health educators to reinforce messages and assess household practices. Delivered over a 12-month period.
Active Comparator: Standard Information Dissemination
Participants receive the standard municipal information package on lead exposure prevention currently distributed by city health departments.
Behavioral: Standard Information Dissemination
Provision of standard municipal information on lead exposure prevention, including pamphlets and website links, as currently distributed by public health authorities. No additional workshops or home visits provided.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Blood Lead Level
Time Frame: Through study completion, an average of 1 year
Mean change in venous blood lead concentration (μg/dL) among index household participants from baseline to 12 months.
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Lead-Related Knowledge
Time Frame: Through study completion, an average of 1 year
Change in scores on a validated questionnaire assessing knowledge of lead exposure risks and prevention strategies.
Through study completion, an average of 1 year
Adoption of Lead-Safe Practices
Time Frame: Through study completion, an average of 1 year
Proportion of households reporting regular use of lead-safe cleaning and food preparation practices, as assessed by structured survey.
Through study completion, an average of 1 year
Environmental Lead Levels in Home
Time Frame: Through study completion, an average of 1 year
Change in environmental lead concentrations (surface dust, tap water) measured in the home.
Through study completion, an average of 1 year
Incidence of New Elevated Blood Lead Cases
Time Frame: Through study completion, an average of 1 year
Number of new cases of blood lead ≥5 μg/dL among children and adults during the study period.
Through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

International Health Strategies LLC

Investigators

  • Study Director: Brian Goldstein, MD MPH, International Health Strategies LLC

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 (Estimated)

October 31, 2026

Primary Completion (Estimated)

November 1, 2028

Study Completion (Estimated)

November 1, 2028

Study Registration Dates

First Submitted

May 27, 2026

First Submitted That Met QC Criteria

June 2, 2026

First Posted (Actual)

June 8, 2026

Study Record Updates

Last Update Posted (Actual)

June 8, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • InternationalHealth2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Still deciding based on direction of the study.

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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