Ambient and Indoor Air Pollution in Pregnancy and the risk of Low birth weight and Ensuing Effects in Infants (APPLE): A cohort study in Bangalore, South India

Background: Exposure to air pollution (IAP) from the combustion of solid fuels is a significant cause of morbidity and mortality in developing countries. Pregnant women exposed to higher pollutant levels are at higher risk of delivering a low-birth-weight (LBW) baby. There is a lack of standardized data regarding the levels and types of specific pollutants and how they impact LBW. We aim to prospectively assess the association between ambient and indoor air pollution levels in pregnancy and low birth weight and understand the subsequent risk of adiposity in these infants. Methods: We will conduct a prospective cohort study of 516 pregnant women recruited before 18 weeks of gestation in the urban slums of Bangalore, who have voluntarily consented to participate. We will estimate the level of air pollutants including coarse particulate matter 10 ug/m3 (PM10 ), fine particulate matter 2.5 ug/m3(PM2.5) and carbon monoxide (CO) parts per million (ppm) levels in both indoor and ambient environment. The follow-up of the delivered children will be done at delivery until the infant is two years old. The association between pollutants and LBW will be evaluated using logistic regression adjusting for potential confounders.Further, we will explore the mediation role of LBW in the hypothesized causal chain of air pollution and adiposity. Nested within a larger Maternal Antecedents of Adiposity and Studying the Transgenerational role of Hyperglycemia and Insulin (MAASTHI) cohort, we can estimate the absolute risk of having low birth weight caused by air pollution and other variables. Discussion: Understanding the association between exposures to ambient and indoor air pollution and low birth weight is essential in India. LBW babies have a higher risk of developing obesity and Non-Communicable Diseases (NCDs) during adulthood. The results from this study can inform the efforts for controlling the air pollution-related chronic diseases in India.</ns4:p

Ambient and Indoor Air Pollution in Pregnancy and the risk of Low birth weight and Ensuing Effects in Infants (APPLE): A cohort study in Bangalore, South India

Background: Exposure to air pollution (IAP) from the combustion of solid fuels is a significant cause of morbidity and mortality in developing countries. Pregnant women exposed to higher pollutant levels are at higher risk of delivering a low-birth-weight (LBW) baby. There is a lack of standardized data regarding the levels and types of specific pollutants and how they impact LBW. We aim to prospectively assess the association between ambient and indoor air pollution levels in pregnancy and low birth weight and understand the subsequent risk of adiposity in these infants. Methods: We will conduct a prospective cohort study of 516 pregnant women recruited before 18 weeks of gestation in the urban slums of Bangalore, who have voluntarily consented to participate. We will estimate the level of air pollutants including coarse particulate matter 10 ug/m3 (PM10 ), fine particulate matter 2.5 ug/m3(PM2.5) and carbon monoxide (CO) parts per million (ppm) levels in both indoor and ambient environment. The follow-up of the delivered children will be done at delivery until the infant is two years old. The association between pollutants and LBW will be evaluated using logistic regression adjusting for potential confounders.Further, we will explore the mediation role of LBW in the hypothesized causal chain of air pollution and adiposity. Nested within a larger Maternal Antecedents of Adiposity and Studying the Transgenerational role of Hyperglycemia and Insulin (MAASTHI) cohort, we can estimate the absolute risk of having low birth weight caused by air pollution and other variables. Discussion: Understanding the association between exposures to ambient and indoor air pollution and low birth weight is essential in India. LBW babies have a higher risk of developing obesity and Non-Communicable Diseases (NCDs) during adulthood. The results from this study can inform the efforts for controlling the air pollution-related chronic diseases in India.</ns4:p

What makes the pregnant women revisit public hospitals for research? Participant engagement and retention trial in a public hospital (PERTH): an RCT protocol.

BACKGROUND: Cohort studies have public health importance as they effectively provide evidence on determinants of health from a life course perspective. Researchers often confront the poor follow-up rates as a major challenge in the successful conduct of cohort studies. We are currently recruiting in a birth cohort study, titled as "Maternal Antecedents of Adiposity and Studying the Transgenerational role of Hyperglycemia and Insulin" (MAASTHI) in a public hospital; with the aim of assessing maternal glycemic levels on the risk of adverse fetal outcomes. Nested within the ongoing cohort, the proposed trial aims to evaluate the effectiveness of two interventions in improving the follow-up in the cohort study in a public hospital. METHODS: A randomized trial of 795 pregnant women, with 265 women each in three arms observed through pregnancy, until their baby is 14 weeks old. The comparator group receives a standard leaflet, with details on the importance of glucose testing and regular follow up in pregnancy. Intervention arm-1 will receive the standard leaflet plus individualized messages, through an Interactive Voice Response (IVR) system; a type of computer-linked telephone intervention system to remind the participants about the lab test and follow-up dates. Intervention arm- 2 will have the opportunity to attend Mother and Baby Affairs (MBA) workshops, which will provide information on Gestational Diabetes Mellitus (GDM) screening and management to pregnant women and personalized counselling services. The outcome of interest is the difference in the proportion of participants completing follow-up at different points in time, among three arms. DISCUSSION: Between the two interventions (IVR and MBA), the study results would uncover the contextually specific, timely intervention, which can increase the proportion of pregnant women followed up in public hospitals. If effective, this study will provide information on an effective intervention, useful in ensuring the success of longitudinal follow-up in the public hospitals. TRIAL REGISTRATION: NCT03088501 , Date Registered: 16/03/2017

Do Gestational Obesity and Gestational Diabetes Have an Independent Effect on Neonatal Adiposity? Results of Mediation Analysis from a Cohort Study in South India.

PURPOSE: Neonates born to mothers with obesity or gestational diabetes mellitus (GDM) have an increased chance of various metabolic disorders later in life. In India, it is unclear whether maternal obesity or GDM is related to offspring adiposity. We aimed to understand the independent effect of maternal obesity and GDM with neonatal adiposity and whether GDM has a mediating effect between maternal obesity and neonatal adiposity. METHODS: We recruited a cohort of 1120 women (between April 2016 and February 2019) from the public hospitals in Bangalore, India, who voluntarily agreed to participate and provided written informed consent. The primary outcome was neonatal adiposity, defined as the sum of skinfold thickness >85th percentile. Exposure included maternal obesity, defined as >90th percentile of skinfold thickness. GDM, the potential mediator, was classified using the World Health Organization criteria by oral glucose tolerance test. Binary logistic regression was applied to test the effect of maternal obesity and GDM on neonatal adiposity, adjusting for potential confounders. We used Paramed command in STATA version 14 for analyzing mediating effects. RESULTS: We found that maternal obesity (odds ratio (OR)=2.16, 95% CI 1.46, 3.18) and GDM (OR=2.21, 95% CI1.38, 3.52) have an independent effect on neonatal adiposity. GDM significantly mediates 25.2% of the total effect between maternal obesity and neonatal adiposity, (natural direct effect OR = 1.16 95% CI 1.04, 1.30) with significant direct effect of maternal obesity (natural direct effect OR = 1.90 95% CI 1.16, 3.10) and significant total effect (OR=2.20 95% CI 1.35, 3.58). CONCLUSION: We showed that maternal obesity and GDM are independently associated with offspring adiposity. Also, GDM mediates the association of maternal obesity on adiposity in children. Interventions focused on obesity prevention in women, and effective screening and management of GDM may contribute to reducing childhood obesity in India

Cohort profile: maternal antecedents of adiposity and studying the transgenerational role of hyperglycaemia and insulin (MAASTHI).

PURPOSE: The Maternal Antecedents of Adiposity and Studying the transgenerational role of Hyperglycaemia and Insulin cohort in Bengaluru, South India, aims to understand the transgenerational role of increased circulating glucose levels or hyperglycaemia and other nutrients and psychosocial environment, on the risk of childhood obesity, as an early marker of chronic diseases. PARTICIPANTS: Through this paper, we describe the baseline characteristics of the cohort participants and their children, along with plans and challenges. A total of 5694 pregnant women were screened, with 4862 (85.4%) eligible pregnant women recruited at baseline. We assessed anthropometry, Haemoglobin status, Oral Glucose Tolerance Test (OGTT), dietary practices, depressive symptoms using the Edinburgh Postnatal Depression Scale and social support in all women. Follow-up visits involved assessing anthropometry and the health profile of mothers and children. FINDINGS TO DATE: Among 4862 eligible participants recruited, 3260 (67%) underwent OGTT, while 2962 participants completed OGTT (90.9%). During the pregnancy, 9.7% of women were obese (>90th percentile of skinfold thickness), and 14.3% had gestational diabetesmellitus. Moreover, 6.2% and 16.8% of women had symptoms suggestive of depression during pregnancy and the immediate postnatal period, respectively. We found that 3.3% of children were small for gestational age, 10.8% were large for gestational age and 9.7% of children were obese at birth. FUTURE PLANS: We have completed recruitment and baseline data collection in 2019, and are conducting annual follow-ups until age 4 of the participant's children. For delineating causal pathways of childhood obesity, blood aliquots are stored in the biorepository. The study will inform policy formulation and community awareness in the prevention and control of non-communicable diseases and health promotion

Association of obesity with hypertension and type 2 diabetes mellitus in India: A meta-analysis of observational studies.

AIM: To perform a meta-analysis of the association of obesity with hypertension and type 2 diabetes mellitus (T2DM) in India among adults. METHODS: To conduct meta-analysis, we performed comprehensive, electronic literature search in the PubMed, CINAHL Plus, and Google Scholar. We restricted the analysis to studies with documentation of some measure of obesity namely; body mass index, waist-hip ratio, waist circumference and diagnosis of hypertension or diagnosis of T2DM. By obtaining summary estimates of all included studies, the meta-analysis was performed using both RevMan version 5 and "metan" command STATA version 11. Heterogeneity was measured by I2 statistic. Funnel plot analysis has been done to assess the study publication bias. RESULTS: Of the 956 studies screened, 18 met the eligibility criteria. The pooled odds ratio between obesity and hypertension was 3.82 (95%CI: 3.39 to 4.25). The heterogeneity around this estimate (I2 statistic) was 0%, indicating low variability. The pooled odds ratio from the included studies showed a statistically significant association between obesity and T2DM (OR = 1.14, 95%CI: 1.04 to 1.24) with a high degree of variability. CONCLUSION: Despite methodological differences, obesity showed significant, potentially plausible association with hypertension and T2DM in studies conducted in India. Being a modifiable risk factor, our study informs setting policy priority and intervention efforts to prevent debilitating complications

Educational films for improving screening and self-management of gestational diabetes in India and Uganda (GUIDES): study protocol for a cluster-randomised controlled trial.

BACKGROUND: The prevalence of gestational diabetes mellitus (GDM) is rising rapidly in many low- and middle-income countries (LMICs). Most women with GDM in LMICs are undiagnosed and/or inadequately managed due to a lack of knowledge and skills about GDM on the part of both providers and patients. Following contextual analysis, we developed an educational/behavioural intervention for GDM delivered through a package of culturally tailored films. This trial aims to evaluate whether the intervention can improve the timely detection and management of GDM in two LMIC settings. METHODS: Two independent cluster randomised controlled trials, one each to be conducted in Uganda and India. Thirty maternity facilities in each country have been recruited to the study and randomised in a 1:1 ratio to the intervention and control arms. The intervention comprises of three interconnected sets of films with the following aims: to improve knowledge of GDM guidelines and skills of health providers, to raise awareness of GDM screening among pregnant women and their families, and to improve confidence and skills in self-management among those diagnosed with GDM. In facilities randomised to the intervention arm, a GDM awareness-raising film will be shown in antenatal care waiting rooms, and four films for pregnant women with GDM will be shown in group settings and made available for viewing on mobile devices. Short films for doctors and nurses will be presented at professional development meetings. Data will be collected on approximately 10,000 pregnant women receiving care at participating facilities, with follow-up at 32 weeks gestational age and 6 weeks postnatally. Women who self-report a GDM diagnosis will be invited for a clinic visit at 34 weeks. Primary outcomes are (a) the proportion of women who report a GDM diagnosis by 32 weeks of pregnancy and (b) glycaemic control (fasting glucose and HbA1C) in women with GDM at ~34 weeks of pregnancy. The secondary outcome is a composite measure of GDM-related adverse perinatal-neonatal outcome. DISCUSSION: Screening and management of GDM are suboptimal in most LMICs. We hypothesise that a scalable film-based intervention has the potential to improve the timely detection and management of GDM in varied LMIC settings. TRIAL REGISTRATION: ClinicalTrials.gov NCT03937050 , registered on 3 May 2019. Clinical Trials Registry India CTRI/2020/02/023605 , registered on 26 February 2020