Plastic Waste and Human Health Effects in Guatemala

Environmental Exposure Clinical Trial

Official title:

Combustion of Plastic Waste and Human Health Effects in Guatemala

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05130632
• Other study ID #: STUDY00002412
• Secondary ID: R01ES032009-01A1
• Status: Recruiting
• Phase: N/A
• Start date: January 31, 2022
• Est. completion date: May 2026

Study information

• Verified date: October 2023
• Source: Emory University
• Contact: Lisa M Thompson, PhD, RN, FNP
• Phone: 404-712-7350
• Email: lisa.thompson[@]emory.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this cluster-randomized trial 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 as well as other community members from these villages will be enrolled in each group. The follow-up period is 12 months. A Community Advisory Board will be formed in order to provide input on study activities, evaluate working group intervention strategies, and discuss the potential to expand activities regionally. 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.

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.

The aim of this study is to conduct a cluster-randomized trial to evaluate the uptake and sustainability of intervention strategies to reduce use, recycle, and repurpose plastic that will lead to reductions in household-level plastic burning in selected villages in rural Guatemala. The 200 intervention group participants, along with 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 outcomes include personal air pollution exposure, comparison of urinary biomarkers of exposure to plastic combustion, quantification of emissions estimated or air pollutants from plastic incineration, Health-related Quality of Life, self-efficacy and social cohesion, and implementation quality and fidelity of adherence.

In the first year, formative research involving a rapid assessment, formation of a Community Advisory Board, working group refinement, and a working group pilot will occur. The implementation science Capabilities-Opportunities-Motivations-Behavior (COM-B) framework will guide the development of the behavioral intervention (community working groups) during the formative phase. In Years 2 - 4 (the main trial), data collection will include participant surveys (at baseline, 4 months, and 12 months), the community working groups (12 weeks), focus groups (month 12), biomarker (urine) collection (baseline, 4 months and 12 months), plastic waste collection (baseline and 4 months), and modeling activities around emissions scenarios and regional air quality. In Year 5, program evaluation will occur, and results will be disseminated to the participating intervention and control communities and to regional and national policymakers.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2370
• Est. completion date: May 2026
• Est. primary completion date: May 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

For 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

• Report that plastic is burned in household fires (in the cooking stove or outdoors)

Exclusion Criteria:

• Inability to consent

• Cognitively impaired or individuals with impaired decision-making capacity

• Pregnant women. However, women who become pregnant during the course of the study may continue to participate.

• Women who report using tobacco products

Related Conditions & MeSH terms

• Environmental Exposure

Intervention

Behavioral:
• The community working group
The intervention consists of educational working group (WG) sessions over a 12-week period. Eight core modules-the "essential ingredients"-and 4 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 1 task that can be attained in the next 9 months, with the guidance of community workers (promotoras), such as: -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, eliminate plastic packaging -creating materials out of plastic, like bottle planters, crocheted plastic bags, purses.

Locations

Country	Name	City	State
Guatemala	Universidad del Valle de Guatemala	Guatemala
Guatemala	Project Office, Jalapa	Jalapa

Sponsors (5)

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

Country where clinical trial is conducted

Guatemala, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Reach of intervention using the RE-AIM framework	Using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) implementation science framework, the researchers will evaluate working group participants, households in which these women live, and village-level engagement. Reach will be assessed by participants' level of engagement in #/range/types of behavior changes and intensity of change per behavior based on working group strategies.	4-5 months and up to 13 months
Other	Effectiveness of intervention using the RE-AIM framework	Effectiveness will be measured by the level of behavior (high/low) and its effect on health outcomes. Effect of behavior changes (number of participants in community working groups who report reducing, reusing, or recycling plastic and reduced plastic burning) on collective efficacy, general self-efficacy, health-related quality of life, and urinary biomarkers of exposure.	4-5 months and up to 13 months
Other	Adoption of intervention using the RE-AIM framework	Assessment based on quality and fidelity of adherence to working group protocols, assessing working group content that was delivered; training and quality of teaching by fieldworkers and village champions will be assessed through direct observation of working groups. Exposure or dose will be measured by level, range, and intensity of behavior change, including adaptations made to these behavioral changes, among women participating in working groups, in their households, and in their villages.	4-5 months and up to 13 months
Other	Maintenance of Intervention using the RE-AIM framework	Maintenance will be demonstrated by sustained practices that avoid burning plastic in household fires and the reduced consumption and increase of recycling of plastic at the participant, household, and village level. It will be assessed by the number, proportion, and type of working group participants, households, and villages who maintained any adaptation to 1+ behavior and the level of sustained activity per behavior to reduce consumption, increase recycling, and no longer burn plastic	13 months
Primary	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 within and between women.	Baseline, 4-5 months, and up to 13 months
Primary	Change in BC exposure	Air pollution exposure will be assessed using repeated 24-hour measurements. This study will compare differences in personal BC within and between women.	Baseline, 4-5 months, and up to 13 months
Primary	Change in urinary bisphenol level	To assess urinary biomarkers of exposure to plastic combustion, bisphenol level in urine will be evaluated in 200 reproductive-age women participating in the community working groups.	Baseline, 4-5 months, and up to 13 months
Primary	Change in urinary phthalate level	To assess urinary biomarkers of exposure to plastic combustion, phthalate level in urine will be evaluated in 200 reproductive-age women participating in the community working groups.	Baseline, 4-5 months, and up to 13 months
Primary	Change in urinary polycyclic aromatic hydrocarbon level	To assess urinary biomarkers of exposure to plastic combustion, polycyclic aromatic hydrocarbon level in urine will be evaluated in 200 reproductive-age women participating in the community working groups.	Baseline, 4-5 months, and up to 13 months
Primary	Change in urinary volatile organic compound level	To assess urinary biomarkers of exposure to plastic combustion, volatile organic compound level in urine will be evaluated in 200 reproductive-age women participating in the community working groups.	Baseline, 4-5 months, and up to 13 months
Secondary	Change in Health-related Quality of Life Score	Using the HRQOL instrument, the research team will compare differences in quality of life (e.g.: general health, physical and mental health, and daily activity level) within and between women.	Baseline, 4-5 months, and up to 13 months
Secondary	Change in Household Decision Making	Using a 7-part instrument, compare differences in household decision making (e.g., spending earned money, major and minor purchases, job decisions, visiting others) within and between women.	Baseline, 4-5 months, and up to 13 months
Secondary	Change in New General Self-Efficacy Scale (GSE) Score	Using the New General Self-Efficacy Scale (GSE) 8-part instrument, compare differences in self-efficacy (e.g., problem-solving, goal setting, confidence, resourcefulness) within and between women.	Baseline, 4-5 months, and up to 13 months
Secondary	Change in Short Social Capital Assessment Tool Score	Using the 9-part Short Social Capital Assessment Tool, compare differences in Group Membership, Citizenship, and Cognitive Social Capital within and between women.	Baseline, 4-5 months and up to 13 months
Secondary	Change in Community Mobilization Scale Score.	Using the Community Mobilization Scale Score 16-part instrument, compare differences in the Critical Consciousness Sub-scale and the Collective Action Sub-scale within and between women.	Baseline, 4-5 months and up to 13 months
Secondary	Change in the quantification of emissions estimates of air pollutants from plastic incineration.	Using filter-based antimony (Sb) and 1,3,5-Triphenylbenzene (TPB) as tracers of plastic burning and collecting household plastic waste, apportion PM2.5 and quantify emissions estimates of air pollutants from plastic incineration and assess effects of potential emissions reduction on air quality with a chemical transport model.	Baseline, 4-5 months and up to 13 months