Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
400 participants
INTERVENTIONAL
2022-01-31
2026-05-30
Brief Summary
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Detailed Description
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This study aims to conduct a type 1 hybrid-effectiveness-implementation study that uses a village-level cluster-randomized controlled trial design to evaluate the uptake and sustainability of intervention strategies to reduce the use, recycling, and repurposing of plastic that will lead to reductions in household-level plastic burning in selected villages in rural Guatemala. The 200 intervention group participants and other interested community members will participate in 12 weekly behavioral working group sessions. Each intervention community will commit to alternatives to burning plastic and drive initiatives they can achieve over the next 9 months. The 200 control group participants will not receive any specific activities until year 5, when dissemination of results will include control villages. Primary endpoints include personal exposure to air pollution, including particulate matter, black carbon, and other compounds produced while burning solid fuels and plastic waste. Secondary endpoints are assessed using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) implementation science framework.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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The community working group
Female participants over the age of 15 randomized to the intervention group will participate in working group sessions over 12 weeks' time that addresses plastic waste and introduce strategies to reduce use, recycle, and repurpose plastic. Community members of participants in the intervention group will also be invited to participate in the working groups.
The community working group
The intervention consists of educational working group (WG) sessions over 12 weeks. Eight core modules discussing essential elements (such as main problems of solid waste management, health effects of exposure to burning plastic, sustainable alternatives to plastic litter) and four periphery modules to help identify community-driven interventions to reduce plastic burning in household fires, consume less plastic, recycle, and repurpose plastic, will be held.
Participants will prioritize one task that can be attained in the next 9 months, with the guidance of community workers (promotoras), such as:
* engaging in a community clean-up
* starting an organic compost pile free of plastic waste
* training on community recycling, focusing on plastics recycling
* making organic soaps, to use for personal grooming or washing clothes, eliminating plastic packaging
* creating materials out of plastic, like bottle planters
Control Group.
Participants in control villages will receive small trees for reforestation during the intervention activities in the intervention group.
No interventions assigned to this group
Interventions
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The community working group
The intervention consists of educational working group (WG) sessions over 12 weeks. Eight core modules discussing essential elements (such as main problems of solid waste management, health effects of exposure to burning plastic, sustainable alternatives to plastic litter) and four periphery modules to help identify community-driven interventions to reduce plastic burning in household fires, consume less plastic, recycle, and repurpose plastic, will be held.
Participants will prioritize one task that can be attained in the next 9 months, with the guidance of community workers (promotoras), such as:
* engaging in a community clean-up
* starting an organic compost pile free of plastic waste
* training on community recycling, focusing on plastics recycling
* making organic soaps, to use for personal grooming or washing clothes, eliminating plastic packaging
* creating materials out of plastic, like bottle planters
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Over the age of 15
For the collection of urine and personal air pollution samples:
* Women of reproductive age (15 - \<44 years, verified by official document)
* Willingness to attend 12-week working groups
* Willingness to participate in biomonitoring
* Willingness to wear a silicone wristband for 1 week at baseline and 4-5 months
* Household uses biomass as the primary fuel for cooking
* Reports daily participation in household cooking
* Reports that plastic is burned in household fires at least once a week (in the cooking stove or outdoors)
* Plans to live in the household for the next 12 months
For promotoras:
* Over the age of 18
* Ability to read and write
* Women who participate in biomonitoring in the intervention group
* Willingness to make monthly household visits to study participants
* Willingness to make weekly calls to study participants
* Willingness to encourage participation in the activity selected by the village
* Willingness to communicate weekly with the research team
* Willingness to support community meetings to scale up the intervention in intervention and control villages
* Inability to consent
* Cognitively impaired or individuals with impaired decision-making capacity
* Pregnant women. However, women who become pregnant during the study may continue to participate.
* Women who report using tobacco products
15 Years
ALL
Yes
Sponsors
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Universidad del Valle, Guatemala
OTHER
University of California, San Francisco
OTHER
University of Georgia
OTHER
National Institute of Environmental Health Sciences (NIEHS)
NIH
Emory University
OTHER
Responsible Party
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Lisa M. Thompson
Professor
Principal Investigators
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Lisa M Thompson, PhD, RN, FNP
Role: PRINCIPAL_INVESTIGATOR
Emory University - Nell Hodgson Woodruff School of Nursing
Eri Saikawa, PhD
Role: PRINCIPAL_INVESTIGATOR
Emory College of Arts and Sciences: Environmental Sciences
Locations
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Universidad del Valle de Guatemala
Guatemala City, , Guatemala
Project Office, Jalapa
Jalapa, , Guatemala
Countries
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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