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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02812914
Recruitment Status : Completed
First Posted : June 24, 2016
Last Update Posted : October 27, 2017
Sponsor:
Collaborator:
Universidad del Valle, Guatemala
Information provided by (Responsible Party):
University of California, San Francisco

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
Premature Birth Fetal Growth Retardation Infections, Respiratory Exposure to Environmental Pollution, Non-occupational Infant, Small for Gestational Age Other: Low-cost gas stove Behavioral: Peer education classes Behavioral: Resource-intensive behavioral intervention approach Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : April 2016
Actual Primary Completion Date : June 19, 2017
Actual Study Completion Date : June 19, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Air Pollution

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.




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 Measures :
  1. Preterm birth [ Time Frame: At time of birth (within 48 hours) ]
  2. Low birth weight [ Time Frame: At time of birth (within 48 hours) ]
  3. Respiratory illness [ Time Frame: up to one month following birth ]


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02812914


Locations
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Guatemala
San Lorenzo Health Center
San Lorenzo, Guatemala
Sponsors and Collaborators
University of California, San Francisco
Universidad del Valle, Guatemala
Investigators
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Principal Investigator: Lisa M Thompson, RN, PhD, FNP University of California, San Francisco
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02812914    
Other Study ID Numbers: 15-17003
First Posted: June 24, 2016    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017
Additional relevant MeSH terms:
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Respiratory Tract Infections
Premature Birth
Fetal Growth Retardation
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Fetal Diseases
Growth Disorders
Pathologic Processes
Infection
Respiratory Tract Diseases