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

2 juni 2026 uppdaterad av: 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

400

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Förenta staterna
    • Pennsylvania
      • Philadelphia, Pennsylvania, Förenta staterna, 19107
        • Philadelphia City Center
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Ja

Beskrivning

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)

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Beteende: Intensive Public Health Campaign
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.
Aktiv komparator: Standard Information Dissemination
Participants receive the standard municipal information package on lead exposure prevention currently distributed by city health departments.
Beteende: Standard Information Dissemination
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Blood Lead Level
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Lead-Related Knowledge
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

International Health Strategies LLC

Utredare

  • Studierektor: Brian Goldstein, MD MPH, International Health Strategies LLC

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

31 oktober 2026

Primärt slutförande (Beräknad)

1 november 2028

Avslutad studie (Beräknad)

1 november 2028

Studieregistreringsdatum

Först inskickad

27 maj 2026

Först inskickad som uppfyllde QC-kriterierna

2 juni 2026

Första postat (Faktisk)

8 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

8 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

2 juni 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • InternationalHealth2026

Plan för individuella deltagardata (IPD)

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OBESLUTSAM

IPD-planbeskrivning

Still deciding based on direction of the study.

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Studerar en amerikansk FDA-reglerad läkemedelsprodukt

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