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

Sponsor
University of California, San Francisco (Other)
Overall Status
Completed
CT.gov ID
NCT02812914
Collaborator
Universidad del Valle, Guatemala (Other)
50
1
2
14.6
3.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Low-cost gas stove
  • Behavioral: Peer education classes
  • Behavioral: Resource-intensive behavioral intervention approach
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
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 Start Date :
Apr 1, 2016
Actual Primary Completion Date :
Jun 19, 2017
Actual Study Completion Date :
Jun 19, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Phase 1

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

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

Experimental: Phase 2

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

Behavioral: Resource-intensive behavioral intervention approach
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.

Outcome Measures

Primary Outcome Measures

  1. Change in urinary polycyclic aromatic hydrocarbon (PAH) and volatile organic compound (VOC) metabolite concentrations [1) <20 weeks gestation; 2) 28-32 weeks gestation]

  2. 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]

  3. 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]

  4. 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]

  5. 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

  1. Preterm birth [At time of birth (within 48 hours)]

  2. Low birth weight [At time of birth (within 48 hours)]

  3. Respiratory illness [up to one month following birth]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 San Lorenzo Health Center San Lorenzo Guatemala

Sponsors and Collaborators

  • University of California, San Francisco
  • Universidad del Valle, Guatemala

Investigators

  • Principal Investigator: Lisa M Thompson, RN, PhD, FNP, University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT02812914
Other Study ID Numbers:
  • 15-17003
First Posted:
Jun 24, 2016
Last Update Posted:
Oct 27, 2017
Last Verified:
Oct 1, 2017

Study Results

No Results Posted as of Oct 27, 2017