Effects of Cooking with Liquefied Petroleum Gas or Biomass on Stunting in Infants.

BACKGROUND: Household air pollution is associated with stunted growth in infants. Whether the replacement of biomass fuel (e.g., wood, dung, or agricultural crop waste) with liquefied petroleum gas (LPG) for cooking can reduce the risk of stunting is unknown. METHODS: We conducted a randomized trial involving 3200 pregnant women 18 to 34 years of age in four low- and middle-income countries. Women at 9 to less than 20 weeks' gestation were randomly assigned to use a free LPG cookstove with continuous free fuel delivery for 18 months (intervention group) or to continue using a biomass cookstove (control group). The length of each infant was measured at 12 months of age, and personal exposures to fine particulate matter (particles with an aerodynamic diameter of ≤2.5 µm) were monitored starting at pregnancy and continuing until the infants were 1 year of age. The primary outcome for which data are presented in the current report - stunting (defined as a length-for-age z score that was more than two standard deviations below the median of a growth standard) at 12 months of age - was one of four primary outcomes of the trial. Intention-to-treat analyses were performed to estimate the relative risk of stunting. RESULTS: Adherence to the intervention was high, and the intervention resulted in lower prenatal and postnatal 24-hour personal exposures to fine particulate matter than the control (mean prenatal exposure, 35.0 µg per cubic meter vs. 103.3 µg per cubic meter; mean postnatal exposure, 37.9 µg per cubic meter vs. 109.2 µg per cubic meter). Among 3061 live births, 1171 (76.2%) of the 1536 infants born to women in the intervention group and 1186 (77.8%) of the 1525 infants born to women in the control group had a valid length measurement at 12 months of age. Stunting occurred in 321 of the 1171 infants included in the analysis (27.4%) of the infants born to women in the intervention group and in 299 of the 1186 infants included in the analysis (25.2%) of those born to women in the control group (relative risk, 1.10; 98.75% confidence interval, 0.94 to 1.29; P = 0.12). CONCLUSIONS: An intervention strategy starting in pregnancy and aimed at mitigating household air pollution by replacing biomass fuel with LPG for cooking did not reduce the risk of stunting in infants. (Funded by the National Institutes of Health and the Bill and Melinda Gates Foundation; HAPIN ClinicalTrials.gov number, NCT02944682.).

Liquefied Petroleum Gas or Biomass for Cooking and Effects on Birth Weight.

BACKGROUND: Exposure during pregnancy to household air pollution caused by the burning of solid biomass fuel is associated with adverse health outcomes, including low birth weight. Whether the replacement of a biomass cookstove with a liquefied petroleum gas (LPG) cookstove would result in an increase in birth weight is unclear. METHODS: We performed a randomized, controlled trial involving pregnant women (18 to <35 years of age and at 9 to <20 weeks' gestation as confirmed on ultrasonography) in Guatemala, India, Peru, and Rwanda. The women were assigned in a 1:1 ratio to use a free LPG cookstove and fuel (intervention group) or to continue using a biomass cookstove (control group). Birth weight, one of four prespecified primary outcomes, was the primary outcome for this report; data for the other three outcomes are not yet available. Birth weight was measured within 24 hours after birth. In addition, 24-hour personal exposures to fine particulate matter (particles with a diameter of ≤2.5 µm [PM2.5]), black carbon, and carbon monoxide were measured at baseline and twice during pregnancy. RESULTS: A total of 3200 women underwent randomization; 1593 were assigned to the intervention group, and 1607 to the control group. Uptake of the intervention was nearly complete, with traditional biomass cookstoves being used at a median rate of less than 1 day per month. After randomization, the median 24-hour personal exposure to fine particulate matter was 23.9 µg per cubic meter in the intervention group and 70.7 µg per cubic meter in the control group. Among 3061 live births, a valid birth weight was available for 94.9% of the infants born to women in the intervention group and for 92.7% of infants born to those in the control group. The mean (±SD) birth weight was 2921±474.3 g in the intervention group and 2898±467.9 g in the control group, for an adjusted mean difference of 19.6 g (95% confidence interval, -10.1 to 49.2). CONCLUSIONS: The birth weight of infants did not differ significantly between those born to women who used LPG cookstoves and those born to women who used biomass cookstoves. (Funded by the National Institutes of Health and the Bill and Melinda Gates Foundation; HAPIN ClinicalTrials.gov number, NCT02944682.).

Heat Exposure among Adult Women in Rural Tamil Nadu, India.

Exposure to heat is associated with a substantial burden of disease and is an emerging issue in the context of climate change. Heat is of particular concern in India, which is one of the world's hottest countries and also most populous, where relatively little is known about personal heat exposure, particularly in rural areas. Here, we leverage data collected as part of a randomized controlled trial to describe personal temperature exposures of adult women (40-79 years of age) in rural Tamil Nadu. We also characterize measurement error in heat exposure assessment by comparing personal exposure measurements to the nearest ambient monitoring stations and to commonly used modeled temperature data products. We find that temperatures differ across individuals in the same area on the same day, sometimes by more than 5 °C within the same hour, and that some individuals experience sharp increases in heat exposure in the early morning or evening, potentially a result of cooking with solid fuels. We find somewhat stronger correlations between the personal exposure measurements and the modeled products than with ambient monitors. We did not find evidence of systematic biases, which indicates that adjusting for discrepancies between different exposure measurement methods is not straightforward.

Exposure contrasts associated with a liquefied petroleum gas (LPG) intervention at potential field sites for the multi-country household air pollution intervention network (HAPIN) trial in India: results from pilot phase activities in rural Tamil Nadu.

BACKGROUND: The Household Air Pollution Intervention Network (HAPIN) trial aims to assess health benefits of a liquefied petroleum gas (LPG) cookfuel and stove intervention among women and children across four low- and middle-income countries (LMICs). We measured exposure contrasts for women, achievable under alternative conditions of biomass or LPG cookfuel use, at potential HAPIN field sites in India, to aid in site selection for the main trial. METHODS: We recruited participants from potential field sites within Villupuram and Nagapattinam districts in Tamil Nadu, India, that were identified during a feasibility assessment. We performed. (i) cross-sectional measurements on women (N = 79) using either biomass or LPG as their primary cookfuel and (ii) before-and-after measurements on pregnant women (N = 41), once at baseline while using biomass fuel and twice - at 1 and 2 months - after installation of an LPG stove and free fuel intervention. We involved participants to co-design clothing and instrument stands for personal and area sampling. We measured 24 or 48-h personal exposures and kitchen and ambient concentrations of fine particulate matter (PM2.5) using gravimetric samplers. RESULTS: In the cross-sectional analysis, median (interquartile range, IQR) kitchen PM2.5 concentrations in biomass and LPG using homes were 134 µg/m3 [IQR:71-258] and 27 µg/m3 [IQR:20-47], while corresponding personal exposures were 75 µg/m3 [IQR:55-104] and 36 µg/m3 [IQR:26-46], respectively. In before-and-after analysis, median 48-h personal exposures for pregnant women were 72 µg/m3 [IQR:49-127] at baseline and 25 µg/m3 [IQR:18-35] after the LPG intervention, with a sustained reduction of 93% in mean kitchen PM2.5 concentrations and 78% in mean personal PM2.5 exposures over the 2 month intervention period. Median ambient concentrations were 23 µg/m3 [IQR:19-27). Participant feedback was critical in designing clothing and instrument stands that ensured high compliance. CONCLUSIONS: An LPG stove and fuel intervention in the candidate HAPIN trial field sites in India was deemed suitable for achieving health-relevant exposure reductions. Ambient concentrations indicated limited contributions from other sources. Study results provide critical inputs for the HAPIN trial site selection in India, while also contributing new information on HAP exposures in relation to LPG interventions and among pregnant women in LMICs. TRIAL REGISTRATION: ClinicalTrials.Gov. NCT02944682 ; Prospectively registered on October 17, 2016.

Data management plan and REDCap mobile data capture for a multi-country Household Air Pollution Intervention Network (HAPIN) trial.

Background: Household air pollution (HAP) is a leading environmental risk factor accounting for about 1.6 million premature deaths mainly in low- and middle-income countries (LMICs). However, no multicounty randomized controlled trials have assessed the effect of liquefied petroleum gas (LPG) stove intervention on HAP and maternal and child health outcomes. The Household Air Pollution Intervention Network (HAPIN) was the first to assess this by implementing a common protocol in four LMICs. Objective: This manuscript describes the implementation of the HAPIN data management protocol via Research Electronic Data Capture (REDCap) used to collect over 50 million data points in more than 4000 variables from 80 case report forms (CRFs). Methods: We recruited 800 pregnant women in each study country (Guatemala, India, Peru, and Rwanda) who used biomass fuels in their households. Households were randomly assigned to receive LPG stoves and 18 months of free LPG supply (intervention) or to continue using biomass fuels (control). Households were followed for 18 months and assessed for primary health outcomes: low birth weight, severe pneumonia, and stunting. The HAPIN Data Management Core (DMC) implemented identical REDCap projects for each study site using shared variable names and timelines in local languages. Field staff collected data offline using tablets on the REDCap Mobile Application. Results: Utilizing the REDCap application allowed the HAPIN DMC to collect and store data securely, access data (near real-time), create reports, perform quality control, update questionnaires, and provide timely feedback to local data management teams. Additional REDCap functionalities (e.g. scheduling, data validation, and barcode scanning) supported the study. Conclusions: While the HAPIN trial experienced some challenges, REDCap effectively met HAPIN study goals, including quality data collection and timely reporting and analysis on this important global health trial, and supported more than 40 peer-reviewed scientific publications to date.

Cooking with liquefied petroleum gas or biomass and fetal growth outcomes: a multi-country randomised controlled trial.

BACKGROUND: Household air pollution might lead to fetal growth restriction during pregnancy. We aimed to investigate whether a liquefied petroleum gas (LPG) intervention to reduce personal exposures to household air pollution during pregnancy would alter fetal growth. METHODS: The Household Air Pollution Intervention Network (HAPIN) trial was an open-label randomised controlled trial conducted in ten resource-limited settings across Guatemala, India, Peru, and Rwanda. Pregnant women aged 18-34 years (9-19 weeks of gestation) were randomly assigned in a 1:1 ratio to receive an LPG stove, continuous fuel delivery, and behavioural messaging or to continue usual cooking with biomass for 18 months. We conducted ultrasound assessments at baseline, 24-28 weeks of gestation (the first pregnancy visit), and 32-36 weeks of gestation (the second pregnancy visit), to measure fetal size; we monitored 24 h personal exposures to household air pollutants during these visits; and we weighed children at birth. We conducted intention-to-treat analyses to estimate differences in fetal size between the intervention and control group, and exposure-response analyses to identify associations between household air pollutants and fetal size. This trial is registered with ClinicalTrials.gov (NCT02944682). FINDINGS: Between May 7, 2018, and Feb 29, 2020, we randomly assigned 3200 pregnant women (1593 to the intervention group and 1607 to the control group). The mean gestational age was 14·5 (SD 3·0) weeks and mean maternal age was 25·6 (4·5) years. We obtained ultrasound assessments in 3147 (98·3%) women at baseline, 3052 (95·4%) women at the first pregnancy visit, and 2962 (92·6%) at the second pregnancy visit, through to Aug 25, 2020. Intervention adherence was high (the median proportion of days with biomass stove use was 0·0%, IQR 0·0-1·6) and pregnant women in the intervention group had lower mean exposures to particulate matter with a diameter less than 2·5 µm (PM2·5; 35·0 [SD 37·2] µg/m3vs 103·3 [97·9] µg/m3) than did women in the control group. We did not find differences in averaged post-randomisation Z scores for head circumference (0·30 vs 0·39; p=0·04), abdominal circumference (0·38 vs 0·39; p=0·99), femur length (0·44 vs 0·45; p=0·73), and estimated fetal weight or birthweight (-0·13 vs -0·12; p=0·70) between the intervention and control groups. Personal exposures to household air pollutants were not associated with fetal size. INTERPRETATION: Although an LPG cooking intervention successfully reduced personal exposure to air pollution during pregnancy, it did not affect fetal size. Our findings do not support the use of unvented liquefied petroleum gas stoves as a strategy to increase fetal growth in settings were biomass fuels are used predominantly for cooking. FUNDING: US National Institutes of Health and Bill & Melinda Gates Foundation. TRANSLATIONS: For the Kinyarwanda, Spanish and Tamil translations of the abstract see Supplementary Materials section.

Exposure-response relationships for personal exposure to fine particulate matter (PM2·5), carbon monoxide, and black carbon and birthweight: an observational analysis of the multicountry Household Air Pollution Intervention Network (HAPIN) trial.

BACKGROUND: Household air pollution (HAP) from solid fuel use is associated with adverse birth outcomes, but data for exposure-response relationships are scarce. We examined associations between HAP exposures and birthweight in rural Guatemala, India, Peru, and Rwanda during the Household Air Pollution Intervention Network (HAPIN) trial. METHODS: The HAPIN trial recruited pregnant women (9-<20 weeks of gestation) in rural Guatemala, India, Peru, and Rwanda and randomly allocated them to receive a liquefied petroleum gas stove or not (ie, and continue to use biomass fuel). The primary outcomes were birthweight, length-for-age, severe pneumonia, and maternal systolic blood pressure. In this exposure-response subanalysis, we measured 24-h personal exposures to PM2·5, carbon monoxide, and black carbon once pre-intervention (baseline) and twice post-intervention (at 24-28 weeks and 32-36 weeks of gestation), as well as birthweight within 24 h of birth. We examined the relationship between the average prenatal exposure and birthweight or weight-for-gestational age Z scores using multivariate-regression models, controlling for the mother's age, nulliparity, diet diversity, food insecurity, BMI, the mother's education, neonate sex, haemoglobin, second-hand smoke, and geographical indicator for randomisation strata. FINDINGS: Between March, 2018, and February, 2020, 3200 pregnant women were recruited. An interquartile increase in the average prenatal exposure to PM2·5 (74·5 µg/m3) was associated with a reduction in birthweight and gestational age Z scores (birthweight: -14·8 g [95% CI -28·7 to -0·8]; gestational age Z scores: -0·03 [-0·06 to 0·00]), as was an interquartile increase in black carbon (7·3 µg/m3; -21·9 g [-37·7 to -6·1]; -0·05 [-0·08 to -0·01]). Carbon monoxide exposure was not associated with these outcomes (1·7; -3·1 [-12·1 to 5·8]; -0·003 [-0·023 to 0·017]). INTERPRETATION: Continuing efforts are needed to reduce HAP exposure alongside other drivers of low birthweight in low-income and middle-income countries. FUNDING: US National Institutes of Health (1UM1HL134590) and the Bill & Melinda Gates Foundation (OPP1131279).

Risk of diabetes in subjects with sedentary profession and the synergistic effect of positive family history of diabetes.

BACKGROUND: Sedentarism in the workplace, which accelerates risk of diabetes, is least explored in the Indian population. The primary objective of this study was to assess whether prolonged sitting hours in work place predisposes individuals to risk of diabetes and also to estimate risk of diabetes in sedentary workers with a positive family history of diabetes (FHD). SUBJECTS AND METHODS: Data of age-matched 514 subjects previously undiagnosed with diabetes from two different occupational groups (bank employees and schoolteachers) in Chennai, India from opportunistic screening were taken for analysis. The important explanatory variables were body mass index, waist circumference, duration of physical activity, positive FHD, and random capillary blood glucose (RCBG). Logistic regression analyses were done separately to identify determinants of diabetes in each group. Another logistic regression was performed after combining data to estimate risk associated with diabetes among sedentary subjects with positive FHD. RESULTS: Factors associated with elevated RCBG among schoolteachers were systolic and diastolic blood pressure, whereas among bank employees, in addition to blood pressure, duration of sitting in work place and positive FHD were significantly associated with diabetes. Combined data analysis showed that subjects with duration of sitting of ≥180 min/day and a positive FHD are three times at risk of developing diabetes. Adjusting for total physical activity revealed that risk was higher among male subjects. CONCLUSIONS: Increased sitting duration for ≥180 min/day at the workplace was associated with elevated RCBG. There was a threefold higher risk for diabetes among these subjects with positive FHD. Encouraging physical activities in such groups, particularly in men, can be beneficial.

Evaluation of performance of A1c and FPG tests for screening newly diagnosed diabetes defined by an OGTT among tuberculosis patients-a study from India.

AIM: The methods used for diagnosis of diabetes have limitations particularly in situations associated with stress hyperglycemia. Aim of this study was to evaluate the performance of A1c and fasting plasma glucose (FPG) tests for screening newly diagnosed diabetes (NDD) defined by OGTT among tuberculosis (TB) cases in India. METHODS: A total of 983 subjects aged ≥18 years with TB were selected from 7 TB units - 4 urban, 2 rural and 1 semi-urban areas of Tamil Nadu, India, during August 2010-March 2011. Screening for diabetes was carried out by 2-h 75g OGTT. Classification of glucose intolerance status was based on WHO criteria. HbA1c was measured by high performance liquid chromatography using Bio-Rad turbo machine. HbA1c≥47.5mmol/mol was used for diagnosis of diabetes. FPG was estimated by glucose-oxidase method. Known cases of subjects with diabetes were excluded and final analysis was done using data of 779 individuals. The performance of A1c and FPG tests was evaluated against the results of OGTT using receiver operating characteristic curve analysis. RESULTS: Prevalence of NDD was 10.8%. The areas under the curve (AUC) were 0.754 [95% confidence interval (CI) 0.68-0.83] (p<0.001) for A1c and 0.662 (95% CI 0.58-0.74) for FPG (p<0.001) in NDD subjects. The HbA1c cut-off point of ≥47.5mmol/mol gave a sensitivity of 59.1% and specificity of 91.7%, and the respective values were 34.8% and 97.5% for FPG in subjects with NDD. CONCLUSION: HbA1c performed better than FPG as a screening tool for newly diagnosed diabetes among subjects with TB.

Association of diabetes and tuberculosis--a major public health challenge.

The burden of tuberculosis and diabetes is remarkably high in India. There is an increased risk for diabetic subjects to have active form of tuberculosis compared to their normal counterparts. The chance of reactivation of past tuberculosis infection is also common among the people with diabetes. In addition to that, few studies had reported that proportion of poor tuberculosis treatment outcomes such as treatment failure and death was higher in people with both tuberculosis and diabetes. A recent report from Tamil Nadu showed a very high prevalence of diabetes and prediabetes among tuberculosis patients. These findings strongly suggest the need of universal screening for diabetes among tuberculosis patients. There are several questions to be answered to assist in the formulation of strategies to address this dual burden in developing countries like India. The main purpose of the article is to summarise and discuss the available evidences and to define the area of future research to identify a cost-effective screening method for diabetes among tuberculosis patients and the best mode of reporting and managing the two diseases for the better control of tuberculosis and diabetes.

Prevalence of diabetes and pre-diabetes and associated risk factors among tuberculosis patients in India.

BACKGROUND: Diabetes mellitus (DM) is recognised as an important risk factor to tuberculosis (TB). India has high TB burden, along with rising DM prevalence. There are inadequate data on prevalence of DM and pre-diabetes among TB cases in India. Aim was to determine diabetes prevalence among a cohort of TB cases registered under Revised National Tuberculosis Control Program in selected TB units in Tamil Nadu, India, and assess pattern of diabetes management amongst known cases. METHODS: 827 among the eligible patients (n = 904) underwent HbA1c and anthropometric measurements. OGTT was done for patients without previous history of DM and diagnosis was based on WHO criteria. Details of current treatment regimen of TB and DM and DM complications, if any, were recorded. A pretested questionnaire was used to collect information on sociodemographics, habitual risk factors, and type of TB. FINDINGS: DM prevalence was 25.3% (95% CI 22.6-28.5) and that of pre-diabetes 24.5% (95% CI 20.4-27.6). Risk factors associated with DM among TB patients were age (31-35, 36-40, 41-45, 46-50, >50 years vs <30 years) [OR (95% CI) 6.75 (2.36-19.3); 10.46 (3.95-27.7); 18.63 (6.58-52.7); 11.05 (4.31-28.4); 24.7 (9.73-62.7) (p<0.001)], positive family history of DM [3.08 (1.73-5.5) (p<0.001)], sedentary occupation [1.69 (1.10-2.59) (p = 0.016)], and BMI (18.5-22.9, 23-24.9 and ≥25 kg/m(2) vs <18.5 kg/m(2)) [2.03 (1.32-3.12) (p = 0.001); 0.87 (0.31-2.43) (p = 0.78); 1.44 (0.54-3.8) (p = 0.47)]; for pre-diabetes, risk factors were age (36-40, 41-45, 46-50, >50 years vs <30 years) [2.24 (1.1-4.55) (p = 0.026); 6.96 (3.3-14.7); 3.44 (1.83-6.48); 4.3 (2.25-8.2) (p<0.001)], waist circumference [<90 vs. ≥90 cm (men), <80 vs. ≥80 cm (women)] [3.05 (1.35-6.9) (p = 0.007)], smoking [1.92 (1.12-3.28) (p = 0.017)] and monthly income (5000-10,000 INR vs <5000 INR) [0.59 (0.37-0.94) (p = 0.026)]. DM risk was higher among pulmonary TB [3.06 (1.69-5.52) (p<0.001)], especially sputum positive, than non-pulmonary TB. INTERPRETATION: Nearly 50% of TB patients had either diabetes or pre-diabetes.