- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02658383
Community-Engaged Research: A Tool to Advance Cookstove Interventions
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.
Přehled studie
Postavení
Podmínky
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
Intibuca
-
La Esperanza, Intibuca, Honduras
- Field site in Honduras
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Experimentální: 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).
|
Experimentální: 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).
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Change in Blood pressure
Časové okno: 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.
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Change in Inflammation
Časové okno: 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.
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Maggie L Clark, PhD, Colorado State University
Publikace a užitečné odkazy
Obecné publikace
- Benka-Coker ML, Young BN, Keller JP, Walker ES, Rajkumar S, Volckens J, Good N, Quinn C, L'Orange C, Weller ZD, Africano S, Osorto Pinel AB, Peel JL, Clark ML. Impact of the wood-burning Justa cookstove on fine particulate matter exposure: A stepped-wedge randomized trial in rural Honduras. Sci Total Environ. 2021 May 1;767:144369. doi: 10.1016/j.scitotenv.2020.144369. Epub 2020 Dec 29.
- Young BN, Peel JL, Benka-Coker ML, Rajkumar S, Walker ES, Brook RD, Nelson TL, Volckens J, L'Orange C, Good N, Quinn C, Keller JP, Weller ZD, Africano S, Osorto Pinel AB, Clark ML. Study protocol for a stepped-wedge randomized cookstove intervention in rural Honduras: household air pollution and cardiometabolic health. BMC Public Health. 2019 Jul 8;19(1):903. doi: 10.1186/s12889-019-7214-2.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- R00ES022269 (Grant/smlouva NIH USA)
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