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 range18 Years – 79 Years

SexALL

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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

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

Change in Systolic Blood Pressure

Timeframe: Baseline, 3, 5, 9, 12, and 18 months post-randomization (24, 36, 48, and 60 months of age)

Change in Child Linear Growth

Timeframe: Birth (3-5 months post-randomization), and 3, 6, 9, 12, 24, 36, 48 and 60 months of age

Change in Caregiver Reported Early Childhood Development Instrument (CREDI) Score

Timeframe: 3 months of age to 24 months of age

Change in 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