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

October 25, 2017 updated by: University of California, San Francisco
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Guatemala
      • San Lorenzo, Guatemala
        • San Lorenzo Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in urinary polycyclic aromatic hydrocarbon (PAH) and volatile organic compound (VOC) metabolite concentrations
Time Frame: 1) <20 weeks gestation; 2) 28-32 weeks gestation
1) <20 weeks gestation; 2) 28-32 weeks gestation
Change in 48-hour mean personal carbon monoxide exposure
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: Every month from recruitment to neonatal one month of life (up to 9 months)
Every month from recruitment to neonatal one month of life (up to 9 months)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

Universidad del Valle, Guatemala

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (ACTUAL)

June 19, 2017

Study Completion (ACTUAL)

June 19, 2017

Study Registration Dates

First Submitted

June 3, 2016

First Submitted That Met QC Criteria

June 21, 2016

First Posted (ESTIMATE)

June 24, 2016

Study Record Updates

Last Update Posted (ACTUAL)

October 27, 2017

Last Update Submitted That Met QC Criteria

October 25, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-17003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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