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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Brian Goldstein, MD MPH
- Número de teléfono: 215-287-7688
- Correo electrónico: Brian.Goldstein@intlhealthstrategies.com
Ubicaciones de estudio
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Estados Unidos, 19107
- Philadelphia City Center
-
Contacto:
- Brian Goldstein, MD MPH
- Número de teléfono: 215-287-7688
- Correo electrónico: brgold@sas.upenn.edu
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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.
|
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.
|
|
Comparador activo: Standard Information Dissemination
Participants receive the standard municipal information package on lead exposure prevention currently distributed by city health departments.
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Blood Lead Level
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Lead-Related Knowledge
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Brian Goldstein, MD MPH, International Health Strategies LLC
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- InternationalHealth2026
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .