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.
研究概览
地位
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Brian Goldstein, MD MPH
- 电话号码：215-287-7688
- 邮箱：Brian.Goldstein@intlhealthstrategies.com
学习地点
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19107
- Philadelphia City Center
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接触：
- Brian Goldstein, MD MPH
- 电话号码：215-287-7688
- 邮箱：brgold@sas.upenn.edu
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-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
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)
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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.
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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.
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有源比较器：Standard Information Dissemination
Participants receive the standard municipal information package on lead exposure prevention currently distributed by city health departments.
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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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Blood Lead Level
大体时间：Through study completion, an average of 1 year
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Mean change in venous blood lead concentration (μg/dL) among index household participants from baseline to 12 months.
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Through study completion, an average of 1 year
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Lead-Related Knowledge
大体时间：Through study completion, an average of 1 year
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Change in scores on a validated questionnaire assessing knowledge of lead exposure risks and prevention strategies.
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Through study completion, an average of 1 year
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Adoption of Lead-Safe Practices
大体时间：Through study completion, an average of 1 year
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Proportion of households reporting regular use of lead-safe cleaning and food preparation practices, as assessed by structured survey.
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Through study completion, an average of 1 year
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Environmental Lead Levels in Home
大体时间：Through study completion, an average of 1 year
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Change in environmental lead concentrations (surface dust, tap water) measured in the home.
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Through study completion, an average of 1 year
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Incidence of New Elevated Blood Lead Cases
大体时间：Through study completion, an average of 1 year
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Number of new cases of blood lead ≥5 μg/dL among children and adults during the study period.
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Through study completion, an average of 1 year
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合作者和调查者
调查人员
- 研究主任：Brian Goldstein, MD MPH、International Health Strategies LLC
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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