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NCT Number: NCT07632937

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Philadelphia City Center

Philadelphia, Pennsylvania, 19107, United States

Location contact

Brian Goldstein, MD MPH

CONTACT

[email protected]

215-287-7688

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Intensive Public Health Campaign

Behavioral

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.

Standard Information Dissemination

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Brian Goldstein, MD MPH

CONTACT

[email protected]

215-287-7688

Sponsors and collaborators

Lead sponsor

International Health Strategies LLC

Industry

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 8, 2026
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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