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Community-Engaged Research: A Tool to Advance Cookstove Interventions

10. juli 2018 oppdatert av: Colorado State University

Community-Based Participatory Research: A Tool to Advance Cookstove Interventions

Nearly 3 billion people rely on biomass combustion to meet basic domestic energy needs. Many households use traditional cookstoves to meet these energy needs, which can result in extremely high indoor air pollution concentrations. Indoor air pollution from biomass combustion accounts for an estimated 3.9 million premature deaths per year, representing about 4.8% of the global disease burden. Improved stove designs have the potential to substantially reduce indoor air pollution exposures. However, there are few randomized intervention trials, and previous stove intervention studies have been plagued by low improved stove adoption and sustained use, severely limiting interpretations of these studies. This research proposes to conduct community surveys and in-depth interviews among Honduran cookstove users to gain insight into the complex pathways surrounding barriers to and predictors of sustained improved cookstove adoption (among the target population for the proposed intervention). This information will be used to conduct and enhance a randomized improved cookstove intervention among 300 Honduran families, incorporating qualitative and quantitative measures of cookstove use and measuring pre- to post-intervention changes in pollutant exposures and subclinical indicators of cardiovascular health.

The primary goals are twofold:

  • To incorporate community-engaged approaches throughout all aspects of the research
  • To maximize sustained stove use (thereby maximizing the health impact of the intervention) to achieve valid exposure-response estimates.

Both objectives utilize innovative strategies to fill knowledge gaps. The research team will build upon previous studies in Latin America that have focused on identifying and validating appropriate field techniques for exposure and health assessments in rural areas of developing countries.

In summary, the proposed project will provide insight regarding barriers/predictors of sustained cookstove adoption, an issue impeding research in this field; assess the relationship between stove use and indicators of cardiovascular health, a substantial and quickly growing disease burden in developing countries; and result in a more comprehensive and valid assessment of the impact of a cookstove intervention.

Studieoversikt

Studietype

Intervensjonell

Registrering (Faktiske)

222

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Intibuca
      • La Esperanza, Intibuca, Honduras
        • Field site in Honduras

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

24 år til 59 år (Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

Inclusion Criteria:

  • Primary cooks for the household
  • Uses a traditional stove
  • Latina women (representative of the rural Honduran population, no exclusions based on race/ethnicity)

Exclusion Criteria:

  • Non-smoking
  • Not pregnant

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Cleaner cookstove received after visit 2
This arm receives the cleaner cookstove earlier in the study (after visit 2 which is approximately after 6 months)
The participants will change from a traditional wood burning cookstove to a cleaner burning (wood) cookstove called the JUSTA (after visit 2).
Eksperimentell: Cleaner cookstove received after visit 4
This arm receives the cleaner cookstove later in the study (thus acting as a control arm until after visit 4 which is after approximately 1 yr and 6 months)
The participants will change from a traditional wood burning cookstove to a cleaner burning (wood) cookstove called the JUSTA (after visit 4).

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Blood pressure
Tidsramme: The cleaner burning cookstove will be installed in the homes after 2 visits (after approximately 6 months) and after 4 visits (after approximately 1 yr and 6 months) for half of the population, respectively.
Intention to treat analyses will incorporate the repeated measures within participants and the change in blood pressure comparing the two research arms will be the primary outcome of interest. Blood pressure is measured at each of 6 visits spaced approximately 6 months apart over the course of 2.5 years.
The cleaner burning cookstove will be installed in the homes after 2 visits (after approximately 6 months) and after 4 visits (after approximately 1 yr and 6 months) for half of the population, respectively.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Inflammation
Tidsramme: The cleaner burning cookstove will be installed in the homes after 2 visits (after approximately 6 months) and after 4 visits (after approximately 1 yr and 6 months) for half of the population, respectively.
Inflammatory markers will be measured in dried blood spots collected at each of 6 visits spaced approximately 6 months apart. Exhaled nitric oxide will also be measured at each visit to assess pulmonary inflammation. The lab will analyze the dried blood spots after the completion of the study (not at each 6 month interval); planned inflammatory markers include C-reactive protein, intracellular adhesion molecule (ICAM-1), Serum amyloid A, and vascular endothelial cell adhesion molecule (VCAM-1)
The cleaner burning cookstove will be installed in the homes after 2 visits (after approximately 6 months) and after 4 visits (after approximately 1 yr and 6 months) for half of the population, respectively.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Maggie L Clark, PhD, Colorado State University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. august 2015

Primær fullføring (Faktiske)

1. mai 2018

Studiet fullført (Faktiske)

1. mai 2018

Datoer for studieregistrering

Først innsendt

24. august 2015

Først innsendt som oppfylte QC-kriteriene

14. januar 2016

Først lagt ut (Anslag)

18. januar 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

12. juli 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. juli 2018

Sist bekreftet

1. februar 2018

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • R00ES022269 (U.S. NIH-stipend/kontrakt)

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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