Plastic Waste and Human Health Effects in Guatemala

Not Applicable

Suspended

• Conditions: Environmental Exposure
• Interventions: Behavioral: The community working group

• Registration Number: NCT05130632
• Lead Sponsor: Emory University

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. 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

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.

Study Timeline

• Study First Submitted: 2021-10-20
• Study First Submitted QC: 2021-11-10
• Study First Posted: 2021-11-23
• Study Start: 2022-01-31
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-16
• Last Update Posted: 2025-06-19
• Primary Completion: 2026-05-30
• Study Completion: 2026-05-30

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 400

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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The community working group	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.

Primary Outcome Measures

Name	Time	Method
Change in PM2.5 exposure	Baseline, 4-5 months, and up to 13 months	Air 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.
Change in black carbon (BC) exposure	Baseline, 4-5 months, and up to 13 months	Air 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.
Change in urinary bisphenols	Baseline, 4-5 months, and up to 13 months	To assess urinary biomarkers of exposure to plastic combustion, this study will compare differences in bisphenol concentrations among women participating in the two study arms.
Change in urinary phthalates	Baseline, 4-5 months, and up to 13 months	To assess urinary biomarkers of exposure to plastic combustion, this study will compare differences in phthalate concentrations among women participating in the two study arms.
Change in urinary polycyclic aromatic hydrocarbons (PAHs)	Baseline, 4-5 months, and up to 13 months	To 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.
Change in urinary volatile organic compounds (VOCs)	Baseline, 4-5 months, and up to 13 months	To assess urinary biomarkers of exposure to combustion by-products, including plastic, this study will compare differences in VOC concentrations among women participating in the two study arms.

Secondary Outcome Measures

Name	Time	Method
Enablers and barriers to the adoption of the intervention using the RE-AIM implementation science framework	13 months	Using 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 framework	13 months	Using 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.
Reach of intervention using the RE-AIM implementation science framework	4-5 months and up to 13 months	Using 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 framework	4-5 months and up to 13 months	Using 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.
Maintenance of the intervention using the RE-AIM implementation science framework	After 13 months	Using 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.

Trial Locations

Locations (2)

Universidad del Valle de Guatemala; 🇬🇹 Guatemala, Guatemala

Project Office, Jalapa; 🇬🇹 Jalapa, Guatemala