Plastic Waste and Human Health Effects in Guatemala

NCT05130632 | Active Not Recruiting

• 5 other identifiers: STUDY00002412R01ES0320091F31ES0361261P2CES033430-012025P010326
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 2

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.

Conditions

Environmental Exposure

Keywords

Plastic Burning Practice; Plastic Waste Reduction

Outcome Measures

Primary Outcomes (6)

• Change in PM2.5 exposure

  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.

  Baseline, 4-5 months, and 12 - 20 months

• Change in black carbon (BC) exposure

  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.

  Baseline, 4-5 months, and 12 - 20 months

• Change in urinary bisphenols

  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.

  Baseline, 4-5 months, and 12 - 20 months

• Change in urinary phthalates

  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.

  Baseline, 4-5 months, and 12 - 20 months

• Change in urinary polycyclic aromatic hydrocarbons (PAHs)

  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.

  Baseline, 4-5 months, and 12 - 20 months

• Change in urinary volatile organic compounds (VOCs)

  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.

  Baseline, 4-5 months, and 12 - 20 months

Secondary Outcomes (5)

• Reach of intervention using the RE-AIM implementation science framework

  4-5 months and 12 - 20 months

• Effectiveness of intervention using the RE-AIM implementation science framework

  4-5 months and 12 - 20 months

• Enablers and barriers to the adoption of the intervention using the RE-AIM implementation science framework

  20 months

• Adoption of the intervention by direct observation using the RE-AIM implementation science framework

  20 months

• Maintenance of the intervention using the RE-AIM implementation science framework

  After 20 months

Other Outcomes (6)

• Change in Health-related Quality of Life (HRQOL) Score

  Baseline, 4-5 months, and 12 - 20 months

• Change in Household Decision Making

  Baseline, 4-5 months, and 12 - 20 months

• Change in New General Self-Efficacy Scale (NGSE) Score

  Baseline, 4-5 months, and 12 - 20 months

Study Arms (2)

The community working group

EXPERIMENTAL

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.

Behavioral: The community working group

Control Group.

NO INTERVENTION

Participants in control villages will receive small trees for reforestation during the intervention activities in the intervention group.

Interventions

The community working group 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

Also known as: Intervention Group

The community working group

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• For attendees at community working groups:

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad del Valle, Guatemala: collaborator
• University of California, San Francisco: collaborator
• Emory University: lead
• University of Georgia: collaborator
• National Institute of Environmental Health Sciences (NIEHS): collaborator

Study Sites (2)

Universidad del Valle de Guatemala

Guatemala City, Guatemala

Location

Project Office, Jalapa

Jalapa, Guatemala

Location

Related Publications (1)

• Thompson LM, Lovvorn AE, Raheel H, Hengstermann-Artiga M, Lopez MR, Ramirez A, Barr DB, Higgins M, McCracken JP, Saikawa E, Handley MA. A village-level cluster randomized controlled implementation trial to measure the effectiveness of a behavioral intervention aiming to reduce women's exposures to household plastic waste burning in rural Guatemala: study protocol for the Ecolectivos trial. Trials. 2025 Dec 13;27(1):49. doi: 10.1186/s13063-025-09338-z.

  PMID: 41390662 DERIVED

Study Officials

• Eri Saikawa, PhD

  Emory College of Arts and Sciences: Environmental Sciences

  PRINCIPAL INVESTIGATOR

• Lisa M Thompson, PhD, RN, FNP

  Emory University - Nell Hodgson Woodruff School of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: November 23, 2021
• Study Start: January 31, 2022
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: One year after the study ends or when submitting publication (at editor's or funder's request)
• Access Criteria: The research team will create a data request form where they will outline procedures for accessing de-identified data which will include the name and affiliation of researchers, outcomes, and variables being requested with an approved statistical analysis plan.

Locations

GU (2)