NACER II: Reducing Prenatal Exposures to Household Air Pollution in Rural Guatemala Through a Gas Stove/Behavior Intervention to Improve Neonatal Health

Study Overview
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Brief Summary
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Greater efforts are needed to bring affordable, clean stoves and adaptive behavioral strategies to the millions of households worldwide that continue to burn solid cooking fuels using inefficient stoves. Two of the leading causes of infant mortality, preterm birth and pneumonia, are associated with high exposures to household air pollution during pregnancy and early infancy. The proposed study will assess the feasibility and acceptability of an introduced liquid petroleum gas stove, complemented by two alternative approaches to delivering tailored behavioral change interventions, among pregnant women and their neonates.

Official Title
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NACER II: Reducing Prenatal Exposures to Household Air Pollution in Rural Guatemala Through a Gas Stove/Behavior Intervention to Improve Neonatal Health

Conditions
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Premature Birth, Fetal Growth Retardation, Infections, Respiratory, Exposure to Environmental Pollution, Non-occupational, Infant, Small for Gestational Age

Intervention / Treatment
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* Other: Low-cost gas stove
* Behavioral: Peer education classes
* Behavioral: Resource-intensive behavioral intervention approach


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant woman less than 20 weeks gestation Does not smoke cigarettes Uses an open fire or deteriorated woodstove for cooking Purchases wood Intends to stay in the study area for at least one year Uses Ministry of Health clinics for routine prenatal care Has a mobile phone Primary person responsible for cooking in the household Able to give Informed Consent Exclusion Criteria: Multiple pregnancy (eg twins) Identified as a high-risk pregnancy by physician Regularly taking prescription medication Smokes cigarettes Routinely carries a child less than 2 years old on their back

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phase 1<br>In Phase I, 25 pregnant women will receive a low-cost gas stove and will be taught by peer educators in group classes how to safely use gas stoves and how to reduce exposure to air pollution. | Other: Low-cost gas stove<br>* Women will be provided with a 3-burner liquid propane gas stove and one year's supply of gas<br>Behavioral: Peer education classes<br>* Women will participate in four classes on how to safely use gas stoves and methods to reduce exposure to air pollution<br>|
| Experimental: Phase 2<br>In Phase 2, the investigators will assess a more resource-intensive behavioral intervention approach with a different group of 25 women who will follow the same study procedures described in Phase I. | Other: Low-cost gas stove<br>* Women will be provided with a 3-burner liquid propane gas stove and one year's supply of gas<br>Behavioral: Resource-intensive behavioral intervention approach<br>* Women will participate in four classes on how to safely use gas stoves and methods to reduce exposure to air pollution. Additionally, peer educators will visit each home after group classes to help the woman, and key decision-makers in her family, identify top priority strategies to reduce air pollution. Using a checklist, peer educators will observe whether household members are adhering to tailored strategies at subsequent home visits, and provide ongoing support to women and their families.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in urinary polycyclic aromatic hydrocarbon (PAH) and volatile organic compound (VOC) metabolite concentrations |  | 1) <20 weeks gestation; 2) 28-32 weeks gestation | 
| Change in 48-hour mean personal carbon monoxide exposure |  | 1) <20 weeks gestation; 2) 28-32 weeks gestation; 3) Following participation in each behavior change intervention class at 18-24 weeks, 22-28 weeks, and 26-32 weeks gestation; 4) Neonatal after 48 hours, 2 & 4 weeks of life | 
| Change in 48-hour mean kitchen particulate matter concentration |  | 1) <20 weeks gestation; 2) 28-32 weeks gestation; 3) Following participation in each behavior change intervention class at 18-24 weeks, 22-28 weeks, and 26-32 weeks gestation; 4) Neonatal after 48 hours, 2 & 4 weeks of life | 
| Change in 48-hour mean personal particulate matter exposure |  | 1) <20 weeks gestation; 2) 28-32 weeks gestation; 3) Following participation in each behavior change intervention class at 18-24 weeks, 22-28 weeks, and 26-32 weeks gestation; 4) Neonatal after 48 hours, 2 & 4 weeks of life | 
| Change in weekly use of gas stoves (cooking events and total cooking time) using temperature loggers |  | Every month from recruitment to neonatal one month of life (up to 9 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preterm birth |  | At time of birth (within 48 hours) | 
| Low birth weight |  | At time of birth (within 48 hours) | 
| Respiratory illness |  | up to one month following birth |