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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Brian Goldstein, MD MPH
- Numéro de téléphone: 215-287-7688
- E-mail: Brian.Goldstein@intlhealthstrategies.com
Lieux d'étude
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Pennsylvania
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Philadelphia, Pennsylvania, États-Unis, 19107
- Philadelphia City Center
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Contact:
- Brian Goldstein, MD MPH
- Numéro de téléphone: 215-287-7688
- E-mail: brgold@sas.upenn.edu
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La 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)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 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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Comparateur actif: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Blood Lead Level
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Lead-Related Knowledge
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Brian Goldstein, MD MPH, International Health Strategies LLC
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- InternationalHealth2026
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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