Premature BirthNCT02812914
NACER II: Reducing Prenatal Exposures to Household Air Pollution in Rural Guatemala Through a Gas Stove/Behavior Intervention to Improve Neonatal Health
A study testing Low-cost gas stove, Peer education classes and Resource-intensive behavioral intervention approach in people with Premature Birth and Fetal Growth Retardation, run by University of California, San Francisco at 1 site in Guatemala.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premature Birth, Fetal Growth Retardation, Infections, Respiratory
- What is being tested?
- Low-cost gas stove, Peer education classes and Resource-intensive behavioral intervention approach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGuatemala
- Study dates
- Apr 2016to 19 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- Has a mobile phone
- Primary person responsible for cooking in the household
- Able to give Informed Consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Low-cost gas stove, Peer education classes, Resource-intensive behavioral intervention approach
- Medical subject headings
- Premature Birth, Fetal Growth Retardation, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-cost gas stoveOther
Women will be provided with a 3-burner liquid propane gas stove and one year's supply of gas
Peer education classesBehavioural
Women will participate in four classes on how to safely use gas stoves and methods to reduce exposure to air pollution
Resource-intensive behavioral intervention approachBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Low-cost gas stove; Behavioral: Resource-intensive behavioral intervention approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in urinary polycyclic aromatic hydrocarbon (PAH) and volatile organic compound (VOC) metabolite concentrations
Measured: 1) <20 weeks gestation; 2) 28-32 weeks gestation
Change in 48-hour mean personal carbon monoxide exposure
Measured: 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
Measured: 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
Measured: 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
Measured: Every month from recruitment to neonatal one month of life (up to 9 months)
Secondary outcomes (3)
Preterm birth
Measured: At time of birth (within 48 hours)
Low birth weight
Measured: At time of birth (within 48 hours)
Respiratory illness
Measured: up to one month following birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2016 (estimated)
- Study startApr 2016
- Primary completion19 Jun 2017
- Study completion19 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad del Valle, Guatemala
- Responsible party
- Sponsor
- Investigators
- Lisa M Thompson, RN, PhD, FNP, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02812914
- Sponsor's protocol ID
- 15-17003
- Status last verified
- Oct 2017
- First submitted
- 3 Jun 2016
- Last updated
- 27 Oct 2017
- Results posted
- No
Publications
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.
PubMed 31477781Thompson 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.
PubMed 29444650
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NACER II: Reducing Prenatal Exposures to Household Air Pollution in Rural Guatemala Through a Gas Stove/Behavior Intervention to Improve Neonatal Health
- ClinicalTrials.gov ID
- NCT02812914
- Acronym / sponsor ID
- 15-17003
- Conditions
- Premature Birth, Fetal Growth Retardation, Infections, Respiratory, Exposure to Environmental Pollution, Non-occupational, Infant, Small for Gestational Age
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Universidad del Valle, Guatemala
- Study start
- Apr 2016
- Primary completion
- 19 Jun 2017 (actual)
- Study completion
- 19 Jun 2017 (actual)
- First posted
- 24 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1 | Experimental | Other: Low-cost gas stove, Behavioral: Peer education classesIn 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. |
| Phase 2 | Experimental | Other: Low-cost gas stove, Behavioral: Resource-intensive behavioral intervention approachIn 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-cost gas stoveWomen will be provided with a 3-burner liquid propane gas stove and one year's supply of gas | Other | Phase 1, Phase 2 |
| Peer education classesWomen will participate in four classes on how to safely use gas stoves and methods to reduce exposure to air pollution | Behavioural | Phase 1 |
| Resource-intensive behavioral intervention approachWomen 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. | Behavioural | Phase 2 |
Primary outcome
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
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
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
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
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)
3 secondary outcomes
Preterm birth
Time frame: At time of birth (within 48 hours)
Low birth weight
Time frame: At time of birth (within 48 hours)
Respiratory illness
Time frame: up to one month following birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2017.
- Derived from this study: PubMed 31477781Weinstein 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.
- Derived from this study: PubMed 29444650Thompson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa M Thompson, RN, PhD, FNP principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-cost gas stove, Peer education classes and Resource-intensive behavioral intervention approach in people with Premature Birth and Fetal Growth Retardation, run by University of California, San Francisco at 1 site in Guatemala.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Guatemala. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02812914, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2017.