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

Primary Purpose

Premature Birth, Fetal Growth Retardation, Infections, Respiratory

Status

Completed

Phase

Not Applicable

Locations

Guatemala

Study Type

Interventional

Intervention

Low-cost gas stove

Peer education classes

Resource-intensive behavioral intervention approach

About this trial

This is an interventional prevention trial for Premature Birth

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

San Lorenzo Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Phase 1

Phase 2

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in urinary polycyclic aromatic hydrocarbon (PAH) and volatile organic compound (VOC) metabolite concentrations

Change in 48-hour mean personal carbon monoxide exposure

Change in 48-hour mean kitchen particulate matter concentration

Change in 48-hour mean personal particulate matter exposure

Change in weekly use of gas stoves (cooking events and total cooking time) using temperature loggers

Secondary Outcome Measures

Preterm birth

Low birth weight

Respiratory illness

Full Information

NCT ID

NCT02812914

First Posted

June 3, 2016

Last Updated

October 25, 2017

Sponsor

University of California, San Francisco

Collaborators

Universidad del Valle, Guatemala

1. Study Identification

Unique Protocol Identification Number

NCT02812914

Brief Title

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

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Completed

Study Start Date

April 2016 (undefined)

Primary Completion Date

June 19, 2017 (Actual)

Study Completion Date

June 19, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of California, San Francisco

Collaborators

Universidad del Valle, Guatemala

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Phase 1

Arm Type

Experimental

Arm Description

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.

Arm Title

Phase 2

Arm Type

Experimental

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

Low-cost gas stove

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Peer education classes

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Resource-intensive behavioral intervention approach

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Title

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

Title

Change in 48-hour mean kitchen particulate matter concentration

Time Frame

Title

Change in 48-hour mean personal particulate matter exposure

Time Frame

Title

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)

Secondary Outcome Measure Information:

Title

Preterm birth

Time Frame

At time of birth (within 48 hours)

Title

Low birth weight

Time Frame

At time of birth (within 48 hours)

Title

Respiratory illness

Time Frame

up to one month following birth

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lisa M Thompson, RN, PhD, FNP

Organizational Affiliation

University of California, San Francisco

Official's Role

Principal Investigator

Facility Information:

Facility Name

San Lorenzo Health Center

City

San Lorenzo

Country

Guatemala

12. IPD Sharing Statement

Citations:

PubMed Identifier

31477781

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.

Results Reference

derived

PubMed Identifier

29444650

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.

Results Reference

derived

Learn more about this trial

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

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