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

Not Applicable

Completed

• Conditions: Premature Birth; Infections, Respiratory; Exposure to Environmental Pollution, Non-occupational; Infant, Small for Gestational Age; Fetal Growth Retardation
• Interventions: Other: Low-cost gas stove; Behavioral: Peer education classes; Behavioral: Resource-intensive behavioral intervention approach

• Registration Number: NCT02812914
• Lead Sponsor: University of California, San Francisco

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-06-03
• Study First Submitted QC: 2016-06-21
• Study First Posted: 2016-06-24
• Primary Completion: 2017-06-19
• Study Completion: 2017-06-19
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-25
• Last Update Posted: 2017-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phase 1	Low-cost gas stove	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.
Phase 1	Peer education classes	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.
Phase 2	Resource-intensive behavioral intervention approach	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.
Phase 2	Low-cost gas stove	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.

Primary Outcome Measures

Name	Time	Method
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 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)
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

San Lorenzo Health Center; 🇬🇹 San Lorenzo, Guatemala