Plastic Waste and Human Health Effects in Guatemala

NCT ID: NCT05130632

Last Updated: 2025-07-29

Study Results

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-31

Study Completion Date

2026-05-30

Brief Summary

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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. The follow-up period is 12 months. 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

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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.

Conditions

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Environmental Exposure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

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.

Group Type EXPERIMENTAL

The community working group

Intervention Type BEHAVIORAL

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.

Group Type NO_INTERVENTION

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Intervention Group

Eligibility Criteria

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Inclusion Criteria

For attendees at community working groups:

Exclusion Criteria

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


* 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
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad del Valle, Guatemala

OTHER

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role collaborator

University of Georgia

OTHER

Sponsor Role collaborator

National Institute of Environmental Health Sciences (NIEHS)

NIH

Sponsor Role collaborator

Emory University

OTHER

Sponsor Role lead

Responsible Party

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Lisa M. Thompson

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Project Office, Jalapa

Jalapa, , Guatemala

Site Status

Countries

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Guatemala

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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R01ES032009

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1F31ES036126

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1P2CES033430-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00002412

Identifier Type: -

Identifier Source: org_study_id

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