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Interventionsprogram for blyeksponering (LEIP)

26. september 2026 opdateret af: Sarah Benki-Nugent, University of Washington

Interventionsprogram for Blyeksponering

The goal of this clinical trial is to learn if BLL (blood lead level) screening and "healthy home" lead prevention program created in the US is adaptable to a Sub-Saharan African context. It will also work to address child lead exposure in Nairobi, Kenya. The main questions it aims to answer is:

  • Can materials and protocols developed for a US audience be effective in a Sub-Saharan African one?
  • Is there a difference in learning and action between groups that receive different degrees of intervention?

Researchers will compare the outcomes of a group that received lead risk reduction information only in the clinical setting to a group that also received a home visit and tailored risk reduction messages.

Participants will:

  • Have their child's blood lead levels measured at several timepoints
  • Take part in a questionnaire about lead risk
  • Receive lead risk reduction messaging either only in the clinic setting or also in their homes
  • Have their knowledge and risk reduction behaviors measured

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

500

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Karen Jansen
  • Telefonnummer: 206-685-6392
  • E-mail: kjansen@uw.edu

Studiesteder

      • Nairobi, Kenya
        • Dandora and Baba Ndogo Health Centres

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

1 år til 6 år (Barn)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Child age 12-72 months
  • Parent or primary caregiver that is a biological relative is available to give informed consent for LEIP study
  • Parent/caregiver is 18 years of age or older or is an emancipated minor
  • Parent available for 9 months follow-up

Exclusion Criteria:

-Parent unwilling to be contacted for the purposes of tracing and follow-up

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Immediate messages

Caregivers of children with elevated blood lead levels will be provided with immediate messages about lead risk mitigation in the clinic setting. They will receive follow-up at 3 months and 9 months and will complete recall, behavior, and recheck questionnaires and their children will have BLL rechecks.

For children with BLL < 5 ug/dL, the result will be provided to the caregiver, together with standard post-test messaging on reducing lead exposure. A job-aid, such as a poster, showing common sources of lead exposure in children, and important sources of iron rich foods will be used to guide messaging. For BLLs ≥ 5, tailored messaging on potential sources identified on the risk factor survey will be provided.

A random sample of caregivers will complete an in-depth interview to gather barriers, understandability, and acceptability of the lead risk reduction messages received.

Eksperimentel: Home visit

Caregivers of children with elevated blood lead levels will be provided with immediate messages about lead risk mitigation in the clinic setting. They will also receive a home observation visit and have those risk reduction methods reiterated and tailored to their home situation. They will receive follow-up at 3 months and 9 months and will complete recall, behavior, and recheck questionnaires and their children will have BLL rechecks.

For children with BLL < 5 ug/dL, the result will be provided to the caregiver, together with standard post-test messaging on reducing lead exposure. A job-aid, such as a poster, showing common sources of lead exposure in children, and important sources of iron rich foods will be used to guide messaging. For BLLs ≥ 5, tailored messaging on potential sources identified on the risk factor survey will be provided.

A random sample of caregivers will complete an in-depth interview to gather barriers, understandability, and acceptability of the lead risk reduction messages received.

The home visit will be conducted within 2 weeks of initial screening. During the home visit, the lead exposure risk survey will be re-administered, for comparison to in-clinic self-report survey responses. In addition, an observational checklist of potential lead exposure risk factors will be conducted to identify and discuss residential features and items in the home environment that may be influencing their BLL. Tailored messages on lead exposure risk reduction will be provided.

A random sample of caregivers will complete an in-depth interview to gather barriers, understandability, and acceptability of the lead risk reduction messages received.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Recall of survey risk factors
Tidsramme: 3 and 9 months post clinic visit

Lead risk surveys will be completed by participants during the clinic visit and at 3 and 9 months post home visit. Qualitative analysis of the lead risk survey will summarize themes on understandability and acceptability of survey items and messages. The rapid analysis will also explore facilitators and barriers to uptake of recommended exposure reduction measures, and individual level determinants associated with uptake (e.g., empowerment, self-efficacy).

3 and 9 months post clinic visit
Self report of risk-reduction behavior
Tidsramme: 3 and 9 months post clinic visit

Assess the proportion of caregivers self-reporting uptake of at least one of their risk reduction recommendations within arms and by BLL.

3 and 9 months post clinic visit

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Differences in outcomes between arms
Tidsramme: 3 and 9 months post clinic visit

Using risk survey responses and self-reported changes in risk reduction behavior, we will compare the participants of both arms to assess for differences.

3 and 9 months post clinic visit

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Uptake of the BLL re-check
Tidsramme: 3 and 9 months post-initial visit

Return for a re-check visit is an indicator of caregiver awareness of importance of reducing lead exposure. We will summarize the proportions of caregivers returning for each BLL re-check visit for each arm.

3 and 9 months post-initial visit
Change in BLL
Tidsramme: 3 and 9 months post-initial clinic visit

Change in BLL at re-checks. We do not anticipate observing a significant reduction in child BLL, given that caregivers might not have the ability to identify and/or modify a lead risk exposure.

3 and 9 months post-initial clinic visit

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Sarah Benki-Nugent, University of Washington

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. januar 2027

Primær færdiggørelse (Anslået)

1. april 2029

Studieafslutning (Anslået)

1. april 2030

Datoer for studieregistrering

Først indsendt

3. februar 2026

Først indsendt, der opfyldte QC-kriterier

3. februar 2026

Først opslået (Faktiske)

10. februar 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • STUDY00022114
  • 1R01ES036010 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

All data other than patient direct or indirect identifiers will be shared.

IPD-delingsadgangskriterier

Other researchers can contact the MPIs and complete an approved Data Sharing Agreement

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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