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

NCT02812914 | Completed

• 1 other identifier: 15-17003
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• 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

Study Arms (2)

Phase 1

EXPERIMENTAL

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; Behavioral: Peer education classes

Phase 2

EXPERIMENTAL

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; Behavioral: Resource-intensive behavioral intervention approach

Interventions

Low-cost gas stove OTHER

Women will be provided with a 3-burner liquid propane gas stove and one year's supply of gas

Phase 1; Phase 2

Peer education classes BEHAVIORAL

Women will participate in four classes on how to safely use gas stoves and methods to reduce exposure to air pollution

Phase 1

Resource-intensive behavioral intervention approach BEHAVIORAL

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.

Phase 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Universidad del Valle, Guatemala: collaborator

Study Sites (1)

San Lorenzo Health Center

San Lorenzo, Guatemala

Location

Related Publications (2)

• 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.

  PMID: 31477781 DERIVED

• 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.

  PMID: 29444650 DERIVED

MeSH Terms

Conditions

Premature Birth; Fetal Growth Retardation; Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Fetal Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections; Respiratory Tract Diseases

Study Officials

• Lisa M Thompson, RN, PhD, FNP

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2016
• First Posted: June 24, 2016
• Study Start: April 1, 2016
• Primary Completion: June 19, 2017
• Study Completion: June 19, 2017
• Last Updated: October 27, 2017

Record last verified: 2017-10

Locations

GU (1)