CompletedNot Applicable

Household Air Pollution and Health: A Multi-country LPG Intervention Trial

Guatemala, India, Peru3,640 participantsStarted 2017-09-01

Plain-language summary

This study is a randomized controlled trial of liquefied petroleum gas (LPG) stove and fuel distribution in 3,200 households in four countries (India, Guatemala, Peru, and Rwanda). Following a common protocol, each intervention site will recruit 800 pregnant women (aged 18-34 years, 9 - \<20 weeks gestation) and will randomly assign half their households to receive LPG stoves and an 18-month supply of LPG. Control households are anticipated to continue to cook primarily with solid biomass fuels and will receive compensation based on a uniform set of trial-wide principles, customized to each site based on formative research. The mother will be followed along with her child until the child is 1 year old. The researchers estimate that 15% of households will have a second, non-pregnant older adult woman (aged 40 to \<80 years) who will also be enrolled at baseline and followed during the 18-month follow-up period. To optimize intervention use, the researchers will implement behavior change strategies informed by previous experiences and formative research in Year 1. This study will assess cookstove use, conduct repeated personal exposure assessments of household air pollution, and collect dried blood spots and urinary samples for biomarker analysis and biospecimen storage. The primary outcomes are low birth weight, severe pneumonia incidence, and stunting of the child, and systolic blood pressure in the older adult woman. Participants in India, Guatemala and Rwanda will be followed until the child is 5 years old to assess the longer-term effects of the intervention.

Who can participate

Age range

18 Years – 79 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria for Pregnant Women: * Confirmed pregnancy (hCG positive blood or urine test) * Aged 18 to \<35 years (via self-report) * Uses biomass stove predominantly * Lives in study area * 9 - \<20 weeks gestation confirmed by ultrasound * Singleton pregnancy (one fetus) * Viable fetus with normal fetal heart rate (120-180 beats per minute) at time of ultrasound * Continued pregnancy at the time of randomization confirmed by self-report * Agrees to participate with informed consent Exclusion Criteria for Pregnant Women: * Currently smokes cigarettes or other tobacco products * Plans to move permanently outside study area in the next 12 months * Uses LPG stove predominantly, or is likely to use LPG predominantly in the near future Inclusion Criteria for Older Adult Woman in the Same Household: * Aged 40 to \<80 years (via self-report) Exclusion Criteria for Older Adult Woman in the Same Household: * Currently smokes cigarettes or other tobacco products * Pregnant (by self-report) * Plans to move out of her current household in the next 12 months

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Birth weight

Timeframe: Within 24 hours of birth (up to 5 months post-randomization of mother)

Incidence of HAPIN Defined Severe Pneumonia

Timeframe: Up to 12 months after birth

Length-for-age z-score 2 standard deviations below the standard

Timeframe: 12 months after birth

Systolic Blood Pressure Among Older Adult Women

Timeframe: Baseline, 3, 6, 9, 12, and 18 months post-randomization

Child Linear Growth During Extended Follow-up

Timeframe: 24, 36, 48 and 60 months of age

Caregiver Reported Early Childhood Development Instrument (CREDI) Score During Extended Follow-up

Timeframe: 24 months of age

Malawi Developmental Assessment Tool (MDAT) Score

Timeframe: 36, 48 and 60 months of age

Trial details

NCT IDNCT02944682

SponsorEmory University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-30

View on ClinicalTrials.gov More Infant, Low Birth Weight trials