Clinical trial NCT02812914: NACER II: Reducing Prenatal Exposures to Household Air Pollution in Rural Guatemala Through a Gas Stove/Behavior Intervention to Improve Neonatal Health
Official title: NACER II: Reducing Prenatal Exposures to Household Air Pollution in Rural Guatemala Through a Gas Stove/Behavior Intervention to Improve Neonatal Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Birth
Fetal Growth Retardation
Infections, Respiratory
Exposure to Environmental Pollution, Non-occupational
Infant, Small for Gestational Age
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Universidad del Valle, Guatemala
First posted: 2016-06-24
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in urinary polycyclic aromatic hydrocarbon (PAH) and volatile organic compound (VOC) metabolite concentrations
timeFrame: 1) <20 weeks gestation; 2) 28-32 weeks gestation
measure: Change in 48-hour mean personal carbon monoxide exposure
timeFrame: 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
measure: Change in 48-hour mean kitchen particulate matter concentration
timeFrame: 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
measure: Change in 48-hour mean personal particulate matter exposure
timeFrame: 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
measure: Change in weekly use of gas stoves (cooking events and total cooking time) using temperature loggers
timeFrame: Every month from recruitment to neonatal one month of life (up to 9 months)
Secondary outcomes:
measure: Preterm birth
timeFrame: At time of birth (within 48 hours)
measure: Low birth weight
timeFrame: At time of birth (within 48 hours)
measure: Respiratory illness
timeFrame: up to one month following birth
Other outcomes:
Locations:
city: San Lorenzo
country: Guatemala
facility: San Lorenzo Health Center
Study officials:
affiliation: University of California, San Francisco
name: Lisa M Thompson, RN, PhD, FNP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weinstein JR, Diaz-Artiga A, Benowitz N, Thompson LM. Reductions in urinary metabolites of exposure to household air pollution in pregnant, rural Guatemalan women provided liquefied petroleum gas stoves. J Expo Sci Environ Epidemiol. 2020 Mar;30(2):362-373. doi: 10.1038/s41370-019-0163-0. Epub 2019 Sep 2.
citation: Thompson LM, Diaz-Artiga A, Weinstein JR, Handley MA. Designing a behavioral intervention using the COM-B model and the theoretical domains framework to promote gas stove use in rural Guatemala: a formative research study. BMC Public Health. 2018 Feb 14;18(1):253. doi: 10.1186/s12889-018-5138-x.