- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05130632
Plastic Waste and Human Health Effects in Guatemala
Combustion of Plastic Waste and Human Health Effects in Guatemala
Study Overview
Status
Conditions
Intervention / Treatment
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.
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lisa M Thompson, PhD, RN, FNP
- Phone Number: 404-712-7350
- Email: lisa.thompson@emory.edu
Study Contact Backup
- Name: Amy Lovvorn, MPH
- Phone Number: 404-712-7350
- Email: alovvor@emory.edu
Study Locations
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-
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Guatemala, Guatemala
- Not yet recruiting
- Universidad del Valle de Guatemala
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Contact:
- Maria Renee Lopez
- Email: mlopez@ces.uvg.edu
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Principal Investigator:
- Maria Renee Lopez
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Principal Investigator:
- Mayari Hengstermann, PhD
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Jalapa, Guatemala
- Recruiting
- Project Office, Jalapa
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Contact:
- Carla Trinidad Salazar
- Email: ctrinidad@ces.uvg.edu
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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.
Other Names:
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No Intervention: Control Group.
No specific activities
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in PM2.5 exposure
Time Frame: 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 within and between women.
|
Baseline, 4-5 months, and up to 13 months
|
Change in BC exposure
Time Frame: 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 within and between women.
|
Baseline, 4-5 months, and up to 13 months
|
Change in urinary bisphenol level
Time Frame: Baseline, 4-5 months, and up to 13 months
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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.
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Baseline, 4-5 months, and up to 13 months
|
Change in urinary phthalate level
Time Frame: Baseline, 4-5 months, and up to 13 months
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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
|
Change in urinary polycyclic aromatic hydrocarbon level
Time Frame: Baseline, 4-5 months, and up to 13 months
|
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
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Change in urinary volatile organic compound level
Time Frame: Baseline, 4-5 months, and up to 13 months
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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.
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Baseline, 4-5 months, and up to 13 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Health-related Quality of Life Score
Time Frame: Baseline, 4-5 months, and up to 13 months
|
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.
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Baseline, 4-5 months, and up to 13 months
|
Change in Household Decision Making
Time Frame: Baseline, 4-5 months, and up to 13 months
|
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.
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Baseline, 4-5 months, and up to 13 months
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Change in New General Self-Efficacy Scale (GSE) Score
Time Frame: Baseline, 4-5 months, and up to 13 months
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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.
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Baseline, 4-5 months, and up to 13 months
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Change in Short Social Capital Assessment Tool Score
Time Frame: Baseline, 4-5 months and up to 13 months
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Using the 9-part Short Social Capital Assessment Tool, compare differences in Group Membership, Citizenship, and Cognitive Social Capital within and between women.
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Baseline, 4-5 months and up to 13 months
|
Change in Community Mobilization Scale Score.
Time Frame: Baseline, 4-5 months and up to 13 months
|
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.
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Baseline, 4-5 months and up to 13 months
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Change in the quantification of emissions estimates of air pollutants from plastic incineration.
Time Frame: Baseline, 4-5 months and up to 13 months
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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.
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Baseline, 4-5 months and up to 13 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reach of intervention using the RE-AIM framework
Time Frame: 4-5 months and up to 13 months
|
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.
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4-5 months and up to 13 months
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Effectiveness of intervention using the RE-AIM framework
Time Frame: 4-5 months and up to 13 months
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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.
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4-5 months and up to 13 months
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Adoption of intervention using the RE-AIM framework
Time Frame: 4-5 months and up to 13 months
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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.
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4-5 months and up to 13 months
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Maintenance of Intervention using the RE-AIM framework
Time Frame: 13 months
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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
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Lisa M Thompson, PhD, RN, FNP, Emory University-School of Nursing
- Principal Investigator: Eri Saikawa, PhD, Emory College of Arts and Sciences: Environmental Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- STUDY00002412
- R01ES032009-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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