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

2 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

400

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

    • Pennsylvania
      • Philadelphia, Pennsylvania, Stati Uniti, 19107
        • Philadelphia City Center
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

Descrizione

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)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comparatore attivo: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Blood Lead Level
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Lead-Related Knowledge
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Direttore dello studio: Brian Goldstein, MD MPH, International Health Strategies LLC

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

31 ottobre 2026

Completamento primario (Stimato)

1 novembre 2028

Completamento dello studio (Stimato)

1 novembre 2028

Date di iscrizione allo studio

Primo inviato

27 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

2 giugno 2026

Primo Inserito (Effettivo)

8 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

8 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • InternationalHealth2026

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Descrizione del piano IPD

Still deciding based on direction of the study.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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