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Plastic Waste and Human Health Effects in Guatemala

Combustion of Plastic Waste and Human Health Effects in Guatemala

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05130632
Acronym
Ecolectivos
Enrollment
400
Registered
2021-11-23
Start date
2022-01-31
Completion date
2026-05-24
Last updated
2026-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Environmental Exposure

Keywords

Plastic Burning Practice, Plastic Waste Reduction

Brief summary

Ecolectivos is a type-1 hybrid-effectiveness-implementation study that uses a village-level cluster randomized controlled trial design. The goal of this study in rural Guatemala is to assess intervention strategies to reduce plastic burning in 8 intervention villages compared to 8 control villages. The intervention group participants will participate in 12 weekly behavioral working group sessions; the control group will not receive any specific activities. Two hundred women of reproductive age and other community members from these villages will be enrolled in each group. Data will be collected via interviews, focus groups, air pollution sampling, plastic waste collection, urinary biomarker assessments, and ambient air sampling. Program evaluation and results dissemination will occur in the last year of the project.

Detailed description

Household air pollution from solid fuel combustion (e.g., wood) is a major environmental risk factor in low- and middle-income countries, accounting for an estimated 2.6 million deaths annually (World Health Organization, 2018). The contribution of plastic waste incineration in household fires has not been quantified. This is problematic for countries like Guatemala, where 71% of households burn waste as a primary means of disposal (Government of the Republic of Guatemala 2019). Plastic waste incineration is a critical, but understudied, public health and environmental hazard, as communities are inundated with cheap plastic without the means of safely disposing of plastic waste. 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.

Interventions

BEHAVIORALThe 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

Sponsors

Emory University
Lead SponsorOTHER
Universidad del Valle, Guatemala
CollaboratorOTHER
University of California, San Francisco
CollaboratorOTHER
University of Georgia
CollaboratorOTHER
National Institute of Environmental Health Sciences (NIEHS)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

For attendees at community working groups: * There are no inclusion or

Exclusion criteria

as the whole community will be invited For questionnaires administered to workshop attendees: * 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

Design outcomes

Primary

MeasureTime frameDescription
PM2.5 exposureBaseline, 4-5 months, and 12 - 20 monthsAir pollution exposure will be assessed using repeated 24-hour measurements. This study will compare differences in personal PM2.5 exposure among women participating in the two study arms.
Black carbon (BC) exposureBaseline, 4-5 months, and 12 - 20 monthsAir pollution exposure will be assessed using repeated 24-hour measurements. This study will compare differences in personal BC exposure among women participating in the two study arms.
Urinary bisphenolsBaseline and 4-5 monthsTo assess urinary biomarkers of exposure to plastic combustion, this study will compare differences in bisphenol concentrations among women participating in the two study arms.
Urinary phthalatesBaseline and 4-5 monthsTo assess urinary biomarkers of exposure to plastic combustion, this study will compare differences in phthalate concentrations among women participating in the two study arms.
Urinary polycyclic aromatic hydrocarbons (PAHs)Baseline and 4-5 monthsTo assess urinary biomarkers of exposure to combustion by-products, including plastic, this study will compare differences in PAH concentrations among women participating in the two study arms.

Secondary

MeasureTime frameDescription
Reach of intervention using the RE-AIM implementation science framework4-5 months and 12 - 20 monthsUsing the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) implementation science framework, assess the reach of the intervention in the intervention arm, as measured by: 1) the number and proportion of total invited participants who attend working groups; 2) the number and proportion of participants' household members who engage in working group activities; and 3) the number of intervention village members who engage in working group activities.
Effectiveness of intervention using the RE-AIM implementation science framework4-5 months and 12 - 20 monthsUsing the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) implementation science framework, assess the effectiveness of the intervention by measuring the number of intervention group participants who report behavior changes. These changes are categorized as "high" or "low" behaviors based on factors such as working group attendance, engagement in activities, and reported reductions in plastic burning.
Enablers and barriers to the adoption of the intervention using the RE-AIM implementation science framework20 monthsUsing the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM implementation science framework, assess the enablers and barriers to the adoption of the intervention using qualitative data collected from focus groups and interviews with participants and environmental promotoras. This will help identify the factors influencing the uptake of the intervention at the village level. There are no units of measure.
Adoption of the intervention by direct observation using the RE-AIM implementation science framework20 monthsUsing the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) implementation science framework, assess the adoption of the intervention through direct observations of intervention activities, using qualitative data analysis to evaluate the extent of implementation at the community level. There are no units of measure.
Maintenance of the intervention using the RE-AIM implementation science frameworkAfter 20 monthsUsing the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) implementation science framework, assess the maintenance (sustainment of intervention strategies) at the participant, household, and village level, as measured by: 1) number and proportion of participants who report no longer burning plastic in household fires (a measure of de-adoption); 2) number and proportion of households who continue their involvement in intervention activities at the village level after the working groups are completed; and 3) number of community members and organizations who have independently maintained, or established, similar intervention activities in the communities after the working groups are completed in the intervention arm.

Countries

Guatemala

Contacts

PRINCIPAL_INVESTIGATOREri Saikawa, PhD

Emory College of Arts and Sciences: Environmental Sciences

PRINCIPAL_INVESTIGATORLisa M Thompson, PhD, RN, FNP

Emory University - Nell Hodgson Woodruff School of Nursing

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 12, 2026