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.

Corrigendum to "Association of high cortisol levels in pregnancy and altered fetal growth. Results from the MAASTHI, a prospective cohort study, Bengaluru" [The Lancet Regional Health - Southeast Asia 14 (2023) 100196].

[This corrects the article DOI: 10.1016/j.lansea.2023.100196.].

Corrigendum to "Second round statewide sentinel-based population survey for estimation of the burden of active infection and anti-SARS-CoV-2 IgG antibodies in the general population of Karnataka, India, during January-February 2021" [IJID Regions Vol 1(2021) pages 107-116].

[This corrects the article DOI: 10.1016/j.ijregi.2021.10.008.].

Association of high cortisol levels in pregnancy and altered fetal growth. Results from the MAASTHI, a prospective cohort study, Bengaluru.

Background: The role of maternal stress levels on mothers' mental health and fetal growth has been previously studied. However, the evidence linking cortisol exposure during pregnancy to growth outcomes in infants is sparsely available from lower and middle-income countries. We aim to investigate the association of serum cortisol levels in pregnancy with infant birth outcomes and postpartum depressive symptoms in a public health facility in India. Methods: The current study is a part of the maternal antecedents of adiposity and studying the transgenerational role of hyperglycemia and insulin (MAASTHI) prospective cohort. We assessed the relationship between maternal exposure to serum cortisol and adverse neonatal outcomes and postpartum depressive symptoms. Serum cortisol levels in stored blood samples were measured in 230 pregnant women as a biomarker for stress during pregnancy. Pregnant women between 18 and 45 years of age were recruited for the study, presenting at ≥14 weeks of gestation and providing voluntary written informed consent. The Edinburgh Postnatal Depression Scale assessed postpartum depressive symptoms, and detailed infant anthropometric measurements were carried out at birth. Findings: We found that higher levels (>17.66 µg/L) are significantly associated with low birth weight (OR = 2.28; 95% CI 1.21-4.32) and lower weight for length (OR = 2.16; 95% CI 1.07-4.35). The odds of developing postpartum depressive symptoms in pregnant women with higher mean cortisol cut-off levels is 2.3-fold [OR: 2.33, 95% CI (1.17, 4.64)] compared than women with lower cortisol levels. No significant association was found between serum cortisol and infants' birth weight for gestational age, head circumference, the sum of skinfold thickness, and crown-rump length. Interpretation: Our results support the hypothesis that higher maternal cortisol levels may adversely impact birth weight, weight for length in newborns, and postpartum depressive symptoms in mothers. Funding: This study was supported by the India Alliance Senior Fellowship [Grant No. IA/CPHS/20/1/505278] awarded to Giridhara R. Babu.

Maternal depressiveness and infant growth outcomes: Findings from the MAASTHI cohort study in India.

OBJECTIVE: The study aims to examine the association between depressiveness in mothers on infant obesity and stunting at one year of age. METHODS: We enrolled 4829 pregnant women, followed them up at public health facilities in Bengaluru for one year after birth. We collected information on women's sociodemographic characteristics, obstetric history, depressive symptoms during pregnancy and delivery within 48 h. We took infant anthropometric measurements at birth and one year. We used chi-square tests, and calculated an unadjusted odds ratio using univariate logistic regression. We used multivariate logistic regression to examine the association between maternal depressiveness, childhood adiposity, and stunting. RESULTS: We found that the prevalence of depressiveness was 31.8% in mothers who delivered in public health facilities in Bengaluru. Infants born to mothers with depressiveness at birth had 3.9 times higher odds of having larger waist circumference than infants born to mothers with no depressiveness (AOR: 3.96, 95% Confidence Interval: 1.24,12.58) and 1.9 times higher odds of having a larger sum of skinfold thickness (AOR: 1.99, 95% CI: 1.18,3.38). Additionally, we found that infants born to mothers with depressiveness at birth had 1.7 times higher odds of stunting than infants born to mothers with no depressiveness (AOR: 1.72; 95%CI: 1.22,2.43) after adjusting for confounders. CONCLUSION: Our study highlights a high prevalence of depressiveness among mothers seeking antenatal care at a public hospital is associated with an increased risk of infant adiposity and stunting at one year. Further research is needed to understand the underlying mechanisms and identify effective interventions.

Feeding styles and adiposity in children of 6 months- 5 years of age: Protocol for a systematic review and meta- analysis.

Obesity in children is a major public health concern due to the increased risk of developing adverse health outcomes in their future, and disability in adulthood. The existing systematic reviews on the topic are limited in scope, focusing solely on high-income countries and children aged 4-12 years. Hence, we propose to conduct a systematic review and meta-analysis to understand, how exposure to authoritative feeding style versus authoritarian, indulgent, uninvolved compare in terms of its association with adiposity in children aged 6 months to 5 years. Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) guidelines were followed for ensuring the completeness of the protocol. Case-control and cohort studies will be included. Searches will be done using electronic databases viz. PubMed, Ovid EMBASE, PsycINFO and Web of Science. Grey literature will be searched using OpenGrey and Grey Literature Report. We will only include quantitative studies using the developed search strategy. For categorical outcomes, relative risks, odds ratios, and hazard ratios with confidence intervals and for continuous outcomes mean difference with confidence intervals will be used. Risk of Bias In Non-randomized Studies- of Exposure (ROBINS-E) will be used for the evaluation of risk of bias in the individual observational studies. Considering the inherent variability in the observational studies, random effects meta-analysis will also be conducted. If between-study heterogeneity exists, a subgroup analysis based on low and middle-income countries vs. high income countries will be conducted. If the data is not suitable for combining quantitatively, a narrative synthesis will be undertaken. We propose to identify publication bias by using contour-enhanced funnel plots and "trim and fill" method. Outcome reporting bias will be ascertained by comparing the outcomes published in the protocol and the published report. The Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) system will be used to understand the confidence we can have on the effect estimates. Registration: This protocol has been registered in International Prospective Register of Systematic Reviews (PROSPERO) on 13 March 2023 with registration number CRD42023356014.

Psychosocial and sociodemographic factors associated with gestational blood glucose levels in women attending public hospitals: Results from baseline of MAASTHI cohort.

BACKGROUND: Understanding psychosocial environment is important for improving maternal and fetal health outcomes during pregnancy. We aimed to identify the association between gestational blood glucose levels and psychosocial and demographic factors in pregnant women. METHODS: In the MAASTHI pregnancy cohort in Bengaluru, we assessed depressive symptoms, and social support using validated scales at baseline in first trimester. A 2-hour 75 g oral glucose tolerance test (OGTT) was administered between 24-36 weeks of gestation. We examined the relation between psychosocial factors assessed at baseline and gestational blood glucose levels in second/third trimester using multivariate linear regression and explored association between serum cortisol and gestational blood glucose levels in subgroup samples. RESULTS: We found that 9% of pregnant women had depressive symptoms and 14.3% had Gestational Diabetes Mellitus (GDM). Psychosocial factors, including depressive symptoms, have a significant correlation with gestational fasting(ß = 0.12, p-value<0.05) and postprandial blood sugar level(ß = 0.23, p-value<0.05) and poor social support were found to have a significant association with gestational fasting blood glucose levels(ß = 1.45, p-value <0.05) and postprandial blood sugar levels(ß = 2.60, p-value <0.05). The sociodemographic factors such as respondent education, occupation, social and economic status were associated with gestational blood sugar after adjusting for potential confounder variables. CONCLUSION: Depressive symptoms and poor social support earlier in pregnancy were significantly associated with increased gestational blood glucose levels. Early detection and recognition of modifiable psychosocial risk factors can reduce glucose intolerance during pregnancy. Evaluating the benefits of screening for psychosocial factors and timely management of gestational diabetes mellitus can be helpful 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.

Second round statewide sentinel-based population survey for estimation of the burden of active infection and anti-SARS-CoV-2 IgG antibodies in the general population of Karnataka, India, during January-February 2021.

Objective: Demonstrate the feasibility of using the existing sentinel surveillance infrastructure to conduct the second round of the serial cross-sectional sentinel-based population survey. Assess active infection, seroprevalence, and their evolution in the general population across Karnataka. Identify local variations for locally appropriate actions. Additionally, assess the clinical sensitivity of the testing kit used on account of variability of antibody levels in the population. Methods: The cross-sectional study of 41,228 participants across 290 healthcare facilities in all 30 districts of Karnataka was done among three groups of participants (low, moderate, and high-risk). The geographical spread was sufficient to capture local variations. Consenting participants were subjected to real-time reverse transcription-polymerase chain reaction (RT-PCR) testing, and antibody (IgG) testing. Clinical sensitivity was assessed by conducting a longitudinal study among participants identified as COVID-19 positive in the first survey round. Results: Overall weighted adjusted seroprevalence of IgG was 15.6% (95% CI: 14.9-16.3), crude IgG prevalence was 15.0% and crude active infection was 0.5%. Statewide infection fatality rate (IFR) was estimated as 0.11%, and COVID-19 burden estimated between 26.1 to 37.7% (at 90% confidence). Further, Cases-to-infections ratio (CIR) varied 3-35 across units and IFR varied 0.04-0.50% across units. Clinical sensitivity of the IgG ELISA test kit was estimated as ≥38.9%. Conclusion: We demonstrated the feasibility and simplicity of sentinel-based population survey in measuring variations in subnational and local data, useful for locally appropriate actions in different locations. The sentinel-based population survey thus helped identify districts that needed better testing, reporting, and clinical management. The state was far from attaining natural immunity during the survey and hence must step up vaccination coverage and enforce public health measures to prevent the spread of COVD-19.