{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,17]],"date-time":"2026-05-17T01:06:57Z","timestamp":1778980017481,"version":"3.51.4"},"update-to":[{"DOI":"10.12688\/wellcomeopenres.22817.1","type":"new_version","label":"New version","source":"publisher","updated":{"date-parts":[[2024,11,22]],"date-time":"2024-11-22T00:00:00Z","timestamp":1732233600000}}],"reference-count":107,"publisher":"F1000 Research Ltd","license":[{"start":{"date-parts":[[2024,11,22]],"date-time":"2024-11-22T00:00:00Z","timestamp":1732233600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100009053","name":"Wellcome Trust DBT India Alliance","doi-asserted-by":"publisher","award":["IA\/TSG\/20\/1\/600023"],"award-info":[{"award-number":["IA\/TSG\/20\/1\/600023"]}],"id":[{"id":"10.13039\/501100009053","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["wellcomeopenresearch.org"],"crossmark-restriction":false},"short-container-title":["Wellcome Open Res"],"abstract":"<ns3:p>\n                    Background Over 250 million children are developing sub-optimally due to their exposure to early life adversities. While previous studies have examined the\n                    <ns3:italic>independent<\/ns3:italic>\n                    effects of nutritional status, psychosocial adversities, and environmental pollutants on children\u2019s outcomes, little is known about their interaction and cumulative effects. Objectives This study aims to investigate the independent, interaction, and cumulative effects of nutritional, psychosocial, and environmental factors on children\u2019s cognitive development and mental health in urban and rural India. It also seeks to explain pathways leading to inequities in child outcomes at the individual, household, and neighbourhood levels. Methods A mixed-methods prospective cohort study will be conducted on 1600 caregiver-child dyads (child age 3\u201310 years) in urban and rural India. Nutritional status, psychosocial adversities, environmental pollutants, and child mental health outcomes will be assessed using parent-report questionnaires. Performance-based measures will be used to assess cognitive outcomes. Venous blood and urine samples will be used to measure nutritional and pesticide biomarkers in 500 children. Indoor air pollution will be monitored in 200 households twice, during two seasons. Multilevel regression, weighted quantile sum regression, and Bayesian kernel machine regression will assess the individual and combined effects of exposures on child outcomes. Thematic analysis of in-depth interviews and focus group discussions will explore pathways to middle-and late childhood development inequities. Discussion The data will be used to formulate a Theory of Change (ToC) to explain the biological, psychosocial, and environmental origins of children\u2019s cognitive and mental health outcomes across the first decade of life in diverse Indian settings, which can inform interventions targets for promoting children\u2019s outcomes beyond the first 1000 days, potentially generalizable to similar under-resourced global settings. The COINCIDE research infrastructure will comprise a valuable global health resource, including prospective cohort data, validated study tools, and stored biological and environmental samples for future studies.\n                  <\/ns3:p>","DOI":"10.12688\/wellcomeopenres.22817.2","type":"journal-article","created":{"date-parts":[[2024,11,22]],"date-time":"2024-11-22T13:10:09Z","timestamp":1732281009000},"page":"486","update-policy":"https:\/\/doi.org\/10.12688\/wellcomeopenres.crossmark-policy","source":"Crossref","is-referenced-by-count":5,"title":["Protocol of the Nutritional, Psychosocial, and Environmental Determinants of Neurodevelopment and Child Mental Health (COINCIDE) 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large-scale meta-analysis of 192 epidemiological studies.","volume":"27","author":"M Solmi","year":"2022","journal-title":"Mol Psychiatry."},{"key":"ref-6","first-page":"9-13","article-title":"Brain development and the role of experience in the early years.","volume":"30","author":"A Tierney","year":"2009","journal-title":"Zero Three."},{"key":"ref-7","doi-asserted-by":"publisher","first-page":"77-90","DOI":"10.1016\/S0140-6736(16)31389-7","article-title":"Early Childhood Development coming of age: science through the life course.","volume":"389","author":"M Black","year":"2017","journal-title":"Lancet."},{"key":"ref-8","doi-asserted-by":"publisher","article-title":"From neurons to neighborhoods: The Science of Early Childhood Development","year":"2000","DOI":"10.17226\/9824"},{"key":"ref-9","doi-asserted-by":"publisher","first-page":"1639-48","DOI":"10.1038\/s41591-023-02426-0","article-title":"Adverse Childhood Experiences and lifelong health.","volume":"29","author":"Z Bhutta","year":"2023","journal-title":"Nat Med."},{"key":"ref-10","doi-asserted-by":"publisher","DOI":"10.1177\/2333794X221078708","article-title":"The Impact of Adverse Childhood Experiences on health and development in young children.","volume":"9","author":"E Webster","year":"2022","journal-title":"Glob Pediatr Health."},{"key":"ref-11","doi-asserted-by":"publisher","first-page":"1114-9","DOI":"10.1097\/PSY.0000000000000421","article-title":"Mechanisms underlying the association between early-life adversity and physical health: charting a course for the future.","volume":"78","author":"N Bush","year":"2016","journal-title":"Psychosom Med."},{"key":"ref-12","doi-asserted-by":"publisher","first-page":"133-43","DOI":"10.1016\/j.tins.2020.01.002","article-title":"Early adversity and critical periods: neurodevelopmental consequences of violating the expectable environment.","volume":"43","author":"C Nelson","year":"2020","journal-title":"Trends 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Country Profiles for Early Childhood Development","year":"2023"},{"key":"ref-15","article-title":"National Family Health Survey (NFHS-5) 2019\u20132020.","year":"2021"},{"key":"ref-16","doi-asserted-by":"publisher","first-page":"1730-40","DOI":"10.1016\/S0140-6736(21)02533-2","article-title":"Health and development from preconception to 20 years of age and human capital.","volume":"399","author":"R Black","year":"2022","journal-title":"Lancet."},{"key":"ref-17","doi-asserted-by":"publisher","first-page":"47-57","DOI":"10.1017\/s2045796011000746","article-title":"Age of onset of mental disorders and use of mental health services: needs, opportunities and obstacles.","volume":"21","author":"G de Girolamo","year":"2012","journal-title":"Epidemiol Psychiatr Sci."},{"key":"ref-18","article-title":"Reaping India\u2019s demographic dividend","year":"2022"},{"key":"ref-19","doi-asserted-by":"publisher","first-page":"97","DOI":"10.3389\/fnhum.2013.00097","article-title":"The role of nutrition 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Psychiatry."},{"key":"ref-23","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0287089","article-title":"Pregnancy pesticide exposure and child development in low- and middle-income countries: a prospective analysis of a birth cohort in rural Bangladesh and meta-analysis.","volume":"18","author":"L Bliznashka","year":"2023","journal-title":"PLoS One."},{"key":"ref-24","doi-asserted-by":"publisher","first-page":"374-81","DOI":"10.1111\/dmcn.14758","article-title":"Air pollution and neurological development in children.","volume":"63","author":"S Ha","year":"2021","journal-title":"Dev Med Child Neurol."},{"key":"ref-25","doi-asserted-by":"publisher","DOI":"10.3389\/ftox.2023.1290119","article-title":"Environmental chemical exposures and mental health outcomes in children: a narrative review of recent literature.","volume":"5","author":"A James","year":"2023","journal-title":"Front 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Sci."},{"key":"ref-29","doi-asserted-by":"publisher","first-page":"10398-416","DOI":"10.3390\/nu7125539","article-title":"Nutritional solutions to reduce risks of negative health impacts of air pollution.","volume":"7","author":"S P\u00e9ter","year":"2015","journal-title":"Nutrients."},{"key":"ref-30","doi-asserted-by":"publisher","first-page":"39-51","DOI":"10.1002\/cad.20363","article-title":"New directions in understanding the role of environmental contaminants in child development: Four themes.","volume":"2020","author":"C Trentacosta","year":"2020","journal-title":"New Dir Child Adolesc Dev."},{"key":"ref-31","doi-asserted-by":"publisher","first-page":"918-20.","DOI":"10.1016\/j.jaci.2016.04.012","article-title":"Synergistic effects of air pollution and psychosocial stressors on adolescent lung function.","volume":"138","author":"G Bandoli","year":"2016","journal-title":"J Allergy Clin Immunol."},{"key":"ref-32","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2022-063794","article-title":"Cohort profile: Maternal Antecedents of Adiposity and Studying the Transgenerational role of Hyperglycaemia and Insulin (MAASTHI).","volume":"12","author":"E Lobo","year":"2022","journal-title":"BMJ Open."},{"key":"ref-33","doi-asserted-by":"publisher","DOI":"10.1186\/s12884-016-1088-4","article-title":"Maternal Antecedents of Adiposity and Studying the Transgenerational role of Hyperglycemia and Insulin (MAASTHI): a prospective cohort study.","volume":"16","author":"G Babu","year":"2016","journal-title":"BMC Pregnancy Childbirth."},{"key":"ref-34","article-title":"SPRING Cluster Randomised Controlled Trial.","year":"2018"},{"key":"ref-35","doi-asserted-by":"publisher","first-page":"1251-7","DOI":"10.1038\/s41390-021-01417-6","article-title":"Delivery mode and altered infant growth at 1 year of life in India.","volume":"90","author":"G Babu","year":"2021","journal-title":"Pediatr Res."},{"key":"ref-36","doi-asserted-by":"publisher","DOI":"10.3389\/fpubh.2020.492596","article-title":"Determinants of breastfeeding practices and its association with infant anthropometry: results from a prospective cohort study in South India.","volume":"8","author":"S Koya","year":"2020","journal-title":"Front Public Health."},{"key":"ref-37","doi-asserted-by":"publisher","first-page":"1067-80","DOI":"10.2147\/CLEP.S222726","article-title":"Do gestational obesity and gestational diabetes have an independent effect on neonatal adiposity? Results of mediation analysis from a cohort study in South India.","volume":"11","author":"G Babu","year":"2019","journal-title":"Clin Epidemiol."},{"key":"ref-38","article-title":"Effect of exposure to ambient Particulate Matter (PM2. 5) onAdverse infant outcomes: an ecological study.","volume":"2","author":"S Prafulla","year":"2019","journal-title":"RGUHS National Journal of Public Health."},{"key":"ref-39","doi-asserted-by":"publisher","DOI":"10.1186\/s12884-021-03915-1","article-title":"Mid-upper arm circumference in pregnant women and birth weight in newborns as substitute for skinfold thickness: findings from the MAASTHI cohort study, India.","volume":"21","author":"G Babu","year":"2021","journal-title":"BMC Pregnancy Childbirth."},{"key":"ref-40","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0293414","article-title":"Psychosocial and sociodemographic factors associated with gestational blood glucose levels in women attending public hospitals: results from baseline of MAASTHI cohort.","volume":"18","author":"P Shriyan","year":"2023","journal-title":"PLoS One."},{"key":"ref-41","doi-asserted-by":"publisher","first-page":"76","DOI":"10.12688\/wellcomeopenres.14618.1","article-title":"Small for gestational age babies and depressive symptoms of mothers during pregnancy: results from a birth cohort in India [version 1; peer review: 1 approved, 1 approved with reservations, 1 not approved].","volume":"3","author":"G Babu","year":"2018","journal-title":"Wellcome Open Res."},{"key":"ref-42","doi-asserted-by":"publisher","DOI":"10.1186\/s40795-020-00388-x","article-title":"Food habits in pregnancy and its association with gestational diabetes mellitus: results from a prospective cohort study in public hospitals of urban India.","volume":"6","author":"R Deepa","year":"2020","journal-title":"BMC Nutr."},{"key":"ref-43","doi-asserted-by":"publisher","first-page":"1793","DOI":"10.3390\/nu15071793","article-title":"Vitamin B6 levels and impaired folate status but not vitamin B12 associated with low birth weight: results from the MAASTHI birth cohort in South India.","volume":"15","author":"R Deepa","year":"2023","journal-title":"Nutrients."},{"key":"ref-44","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpsychores.2021.110390","article-title":"Is physical activity in pregnancy associated with prenatal and postnatal depressive symptoms?: results from MAASTHI cohort study in South India.","volume":"144","author":"Y Ana","year":"2021","journal-title":"J Psychosom Res."},{"key":"ref-45","doi-asserted-by":"publisher","DOI":"10.1016\/j.lansea.2023.100196","article-title":"Association of high cortisol levels in pregnancy and altered fetal growth. Results from the MAASTHI, a prospective cohort study, Bengaluru.","volume":"14","author":"P Shriyan","year":"2023","journal-title":"Lancet Reg Health Southeast Asia."},{"key":"ref-46","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpsychores.2023.111378","article-title":"Maternal depressiveness and infant growth outcomes: findings from the MAASTHI cohort study in India.","volume":"170","author":"P Shriyan","year":"2023","journal-title":"J Psychosom Res."},{"key":"ref-47","doi-asserted-by":"crossref","DOI":"10.26463\/rnjph.3_1_2","article-title":"Development, design, and experience related to android application-based data collection for the MAASTHI cohort study in India.","volume":"3","author":"E Lobo","year":"2018","journal-title":"RGUHS National Journal of Public Health."},{"key":"ref-48","doi-asserted-by":"publisher","first-page":"133","DOI":"10.12688\/wellcomeopenres.14830.3","article-title":"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 [version 3; peer review: 5 approved with reservations, 1 not approved].","volume":"3","author":"P Shriyan","year":"2020","journal-title":"Wellcome Open Res."},{"key":"ref-49","doi-asserted-by":"publisher","DOI":"10.3389\/fnut.2024.1352617","article-title":"Low levels of Vitamin D during pregnancy associated with Gestational Diabetes Mellitus and Low Birth Weight: results from the MAASTHI birth cohort.","volume":"11","author":"R Deepa","year":"2024","journal-title":"Front Nutr."},{"key":"ref-50","doi-asserted-by":"publisher","DOI":"10.3389\/fnut.2023.1155763","article-title":"Effect of the SPRING home visits intervention on early child development and growth in rural India and Pakistan: parallel cluster randomised controlled trials.","volume":"10","author":"B Kirkwood","year":"2023","journal-title":"Front Nutr."},{"key":"ref-51","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0209122","article-title":"Impact of adversity on early childhood growth & development in rural India: findings from the early life stress sub-study of the SPRING cluster randomised controlled trial (SPRING-ELS).","volume":"14","author":"S Bhopal","year":"2019","journal-title":"PLoS One."},{"key":"ref-52","doi-asserted-by":"publisher","first-page":"241-50","DOI":"10.1016\/j.psyneuen.2019.05.012","article-title":"The contribution of childhood adversity to cortisol measures of early life stress amongst infants in rural India: findings from the early life stress sub-study of the SPRING cluster randomised controlled trial (SPRING-ELS).","volume":"107","author":"S Bhopal","year":"2019","journal-title":"Psychoneuroendocrinology."},{"key":"ref-53","article-title":"National Family Health Survey - 5 District Fact Sheet Bangalore Karnataka.","year":"2020"},{"key":"ref-54","article-title":"National Family Health Survey - 5 District Fact Sheet Rewari Haryana.","year":"2021"},{"key":"ref-55","doi-asserted-by":"publisher","first-page":"2170-9","DOI":"10.1111\/jhn.13222","article-title":"Dietary patterns in North and South India: a comparison with EAT-Lancet dietary recommendations.","volume":"36","author":"A Ganpule","year":"2023","journal-title":"J Hum Nutr Diet."},{"key":"ref-56","doi-asserted-by":"publisher","DOI":"10.1186\/s12937-022-00831-8","article-title":"Food insecurity and its determinants among adults in North and South India.","volume":"22","author":"A Ganpule","year":"2023","journal-title":"Nutr J."},{"key":"ref-57","doi-asserted-by":"publisher","DOI":"10.3390\/ijerph18189907","article-title":"Impact of pesticide exposure among rural and urban female population. An overview.","volume":"18","author":"B Dahiri","year":"2021","journal-title":"Int J Environ Res Public Health."},{"key":"ref-58","article-title":"Bayley scales of infant and toddler development.","author":"N Bayley","year":"2006"},{"key":"ref-59","doi-asserted-by":"publisher","DOI":"10.1080\/16549716.2018.1548005","article-title":"Development, feasibility and acceptability of a gamified cognitive DEvelopmental assessment on an E-Platform (DEEP) in rural Indian pre-schoolers - a pilot study.","volume":"12","author":"S Bhavnani","year":"2019","journal-title":"Glob Health Action."},{"key":"ref-60","doi-asserted-by":"publisher","DOI":"10.3389\/fpsyg.2020.01202","article-title":"Proof of concept of a gamified DEvelopmental Assessment on an E-Platform (DEEP) tool to measure cognitive development in rural Indian preschool children.","volume":"11","author":"D Mukherjee","year":"2020","journal-title":"Front Psychol."},{"key":"ref-61","doi-asserted-by":"publisher","first-page":"175-96","DOI":"10.3390\/pediatric15010014","article-title":"Parents 'evaluation of developmental status and strength and difficulties questionnaire as screening measures for children in India: a scoping review.","volume":"15","author":"H Sheel","year":"2023","journal-title":"Pediatr Rep."},{"key":"ref-62","doi-asserted-by":"publisher","first-page":"188-93","DOI":"10.3109\/03014460.2010.506887","article-title":"Nutritional and socioeconomic status in cognitive development of Santal children of Purulia district, India.","volume":"38","author":"S Chowdhury","year":"2011","journal-title":"Ann Hum Biol."},{"key":"ref-63","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijedudev.2021.102409","article-title":"Assessing the assessments: taking stock of learning outcomes data in India.","volume":"84","author":"D Johnson","year":"2021","journal-title":"Int J Educ Dev."},{"key":"ref-64","doi-asserted-by":"publisher","first-page":"1378-87","DOI":"10.1017\/S0007114508066804","article-title":"Dietary micronutrients are associated with higher cognitive function gains among primary school children in rural Kenya.","volume":"101","author":"C Gewa","year":"2009","journal-title":"Br J Nutr."},{"key":"ref-65","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0112605","article-title":"Stunting, poor iron status and parasite infection are significant risk factors for lower cognitive performance in Cambodian school-aged children.","volume":"9","author":"M Perignon","year":"2014","journal-title":"PLoS One."},{"key":"ref-66","doi-asserted-by":"publisher","first-page":"1804-7","DOI":"10.1016\/S0140-6736(05)67574-5","article-title":"Effects of early childhood psychosocial stimulation and nutritional supplementation on cognition and education in growth-stunted Jamaican children: prospective cohort study.","volume":"366","author":"S Walker","year":"2005","journal-title":"Lancet."},{"key":"ref-67","doi-asserted-by":"publisher","first-page":"146-50","DOI":"10.4103\/0970-0218.177536","article-title":"Assessment of self-reported emotional and behavioral difficulties among pre-university college students in Bangalore, India.","volume":"41","author":"P Bhola","year":"2016","journal-title":"Indian J Community Med."},{"key":"ref-68","doi-asserted-by":"publisher","first-page":"306","DOI":"10.12688\/wellcomeopenres.19463.1","article-title":"The Sanitation Hygiene Infant Nutrition Efficacy (SHINE) trial: protocol for school-age follow-up [version 1; peer review: 2 approved].","volume":"8","author":"J Piper","year":"2023","journal-title":"Wellcome Open Res."},{"key":"ref-69","article-title":"Raven standard progressive matrices.","author":"J Raven","year":"1938","journal-title":"Journal of Cognition and Development."},{"key":"ref-70","article-title":"Demographic and health surveys"},{"key":"ref-71","article-title":"Anthropometric standardization reference manual.","author":"T Lohman","year":"1988"},{"key":"ref-72","doi-asserted-by":"publisher","first-page":"1-11","DOI":"10.1016\/j.nutres.2017.11.001","article-title":"Methodological considerations and future insights for 24-hour dietary recall assessment in children.","volume":"51","author":"E Foster","year":"2018","journal-title":"Nutr Res."},{"key":"ref-73","article-title":"Guidelines for measuring household and individual dietary diversity","year":"2014"},{"key":"ref-74","article-title":"Guidelines for Measuring Household and Individual Dietary Diversity.","author":"G Kennedy","year":"2011"},{"key":"ref-75","doi-asserted-by":"publisher","first-page":"509-515","DOI":"10.3928\/0048-5713-20020901-06","article-title":"The PHQ-9: a new depression diagnostic and severity measure.","volume":"32","author":"K Kroenke","year":"2002","journal-title":"Psychiat Ann."},{"key":"ref-76","doi-asserted-by":"publisher","first-page":"782-6","DOI":"10.1192\/bjp.150.6.782","article-title":"Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale.","volume":"150","author":"J Cox","year":"1987","journal-title":"Br J Psychiatry."},{"key":"ref-77","doi-asserted-by":"publisher","DOI":"10.1186\/1471-2458-13-79","article-title":"Rationale and design of South Asian Birth Cohort (START): a Canada-India collaborative study.","volume":"13","author":"S Anand","year":"2013","journal-title":"BMC Public Health."},{"key":"ref-78","article-title":"Child-parent relationship scale.","author":"K Driscoll","year":"1992","journal-title":"J Early Child Infant Psychol."},{"key":"ref-79","article-title":"UNICEF psychosocial care indicators project.","author":"E Frongillo","year":"2003"},{"key":"ref-80","doi-asserted-by":"publisher","first-page":"766-775","DOI":"10.1038\/s41390-019-0431-7","article-title":"Cumulative psychosocial risk and early child development: validation and use of the Childhood Psychosocial Adversity Scale in global health research.","volume":"86","author":"A Berens","year":"2019","journal-title":"Pediatr Res."},{"key":"ref-81","doi-asserted-by":"publisher","first-page":"S14-25","DOI":"10.1038\/sj.jea.7500354","article-title":"Exposure assessment for respirable particulates associated with household fuel use in rural districts of Andhra Pradesh, India.","volume":"14 Suppl 1","author":"K Balakrishnan","year":"2004","journal-title":"J Expo Anal Environ Epidemiol."},{"key":"ref-82","doi-asserted-by":"publisher","DOI":"10.1101\/2024.11.04.24316724","article-title":"A non-specialist worker delivered digital assessment of cognitive development (DEEP) in young children: a longitudinal validation study in rural India.","author":"S Bhavnani","year":"2024","journal-title":"medRxiv."},{"key":"ref-83","doi-asserted-by":"publisher","first-page":"581-6","DOI":"10.1111\/j.1469-7610.1997.tb01545.x","article-title":"The Strengths and Difficulties Questionnaire: a research note.","volume":"38","author":"R Goodman","year":"1997","journal-title":"J Child Psychol Psychiatry."},{"key":"ref-84","first-page":"2018","article-title":"Validating the ASER testing tools: comparisons with reading fluency measures and the read India measures.","volume":"30","author":"S Vagh","year":"2012"},{"key":"ref-85","article-title":"Rashtriya Bal Swasthya Karyakram (RBSK) child health screening and early intervention services","year":"2014"},{"key":"ref-86","article-title":"Coloured progressive matrices, sets A, A_B, B","author":"J Raven","year":"1962"},{"key":"ref-87","doi-asserted-by":"publisher","first-page":"877","DOI":"10.3390\/brainsci10110877","article-title":"The Raven's Coloured Progressive Matrices in Healthy Children: A Qualitative Approach.","volume":"10","author":"D Smirni","year":"2020","journal-title":"Brain Sci."},{"key":"ref-88","first-page":"17-22","article-title":"Norm development and reliability of coloured progressive matrices test.","volume":"11","author":"I Barnabas","year":"1995","journal-title":"Journal of Personality and Clinical Studies."},{"key":"ref-89","doi-asserted-by":"publisher","first-page":"204","DOI":"10.1016\/S0140-6736(08)60131-2","article-title":"WHO child growth standards.","volume":"371","author":"M de Onis","year":"2008","journal-title":"Lancet."},{"key":"ref-90","article-title":"WHO child growth standards: length\/height-for-age, weight-for-age, weight-for-length, weight-for-height and body mass index-for-age: methods and development.","year":"2006"},{"key":"ref-91","doi-asserted-by":"publisher","first-page":"167-75","DOI":"10.1093\/ajcp\/aqab013","article-title":"Elemental testing using inductively coupled plasma mass spectrometry in clinical laboratories.","volume":"156","author":"H Yang","year":"2021","journal-title":"Am J Clin Pathol."},{"key":"ref-92","doi-asserted-by":"publisher","DOI":"10.1016\/j.envint.2021.106884","article-title":"Urinary concentrations of dialkylphosphate metabolites of organophosphate pesticides in the Study of Asian Women and their Offspring's Development and Environmental Exposures (SAWASDEE).","volume":"158","author":"B Baumert","year":"2022","journal-title":"Environ Int."},{"key":"ref-93","doi-asserted-by":"publisher","first-page":"5-29","DOI":"10.1016\/S1570-0232(02)00035-1","article-title":"Analytical methods for biological monitoring of exposure to pesticides: a review.","volume":"778","author":"D Barr","year":"2002","journal-title":"J Chromatogr B Analyt Technol Biomed Life Sci."},{"key":"ref-94","doi-asserted-by":"publisher","first-page":"192-200","DOI":"10.1289\/ehp.7337","article-title":"Urinary creatinine concentrations in the U.S. population: implications for urinary biologic monitoring measurements.","volume":"113","author":"D Barr","year":"2005","journal-title":"Environ Health Perspect."},{"key":"ref-95","article-title":"MIE pDR-1500 Instruction Manual Thermo Fisher Scientific.","year":"2014"},{"key":"ref-96","first-page":"52-62","article-title":"NIOSH manual of analytical methods.","author":"A Teass","year":"1998","journal-title":"National Institute for Occupational Safety and Health."},{"key":"ref-97","doi-asserted-by":"publisher","first-page":"1109-20","DOI":"10.1080\/10962247.2016.1201022","article-title":"Comparison of real-time instruments and gravimetric method when measuring particulate matter in a residential building.","volume":"66","author":"Z Wang","year":"2016","journal-title":"J Air Waste Manag Assoc."},{"key":"ref-98","doi-asserted-by":"publisher","DOI":"10.1186\/1478-4505-12-42","article-title":"Advancing the application of systems thinking in health: a realist evaluation of a capacity building programme for district managers in Tumkur, India.","volume":"12","author":"N Prashanth","year":"2014","journal-title":"Health Res Policy Syst."},{"key":"ref-99","doi-asserted-by":"publisher","first-page":"89","DOI":"10.3389\/fpubh.2014.00089","article-title":"Evaluation of capacity-building program of district health managers in India: a contextualized theoretical framework.","volume":"2","author":"N Prashanth","year":"2014","journal-title":"Front Public Health."},{"key":"ref-100","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2023-078712","article-title":"Practices and outcomes of responsive caregiving on child neurodevelopment and mental health across diverse global populations: a scoping review protocol.","volume":"14","author":"E Lobo","year":"2024","journal-title":"BMJ Open."},{"key":"ref-101","doi-asserted-by":"publisher","first-page":"485-515","DOI":"10.1177\/1468794119881985","article-title":"Using the realist interview approach to maintain theoretical awareness in realist studies.","volume":"20","author":"F Mukumbang","year":"2020","journal-title":"Qualitative Res."},{"key":"ref-102","doi-asserted-by":"publisher","DOI":"10.1016\/j.jbi.2019.103208","article-title":"The REDCap consortium: building an international community of software platform partners.","volume":"95","author":"P Harris","year":"2019","journal-title":"J Biomed Inform."},{"key":"ref-103","doi-asserted-by":"publisher","first-page":"377-81","DOI":"10.1016\/j.jbi.2008.08.010","article-title":"Research Electronic Data Capture (REDCap)\u2014A metadata-driven methodology and workflow process for providing translational research informatics support.","volume":"42","author":"P Harris","year":"2009","journal-title":"J Biomed Inform."},{"key":"ref-104","doi-asserted-by":"publisher","first-page":"2224-34","DOI":"10.1002\/sim.3940","article-title":"Distributed lag non-linear models.","volume":"29","author":"A Gasparrini","year":"2010","journal-title":"Stat Med."},{"key":"ref-105","doi-asserted-by":"publisher","first-page":"e1398-e1413","DOI":"10.1016\/S2214-109X(19)30361-4","article-title":"Do effects of early life interventions on linear growth correspond to effects on neurobehavioural development? A systematic review and meta-analysis.","volume":"7","author":"E Prado","year":"2019","journal-title":"Lancet Glob Health."},{"key":"ref-106","doi-asserted-by":"publisher","first-page":"141-9","DOI":"10.1016\/j.childyouth.2016.10.021","article-title":"Adverse childhood experiences and life opportunities: shifting the narrative.","volume":"72","author":"M Metzler","year":"2017","journal-title":"Child Youth Serv Rev."},{"key":"ref-107","doi-asserted-by":"publisher","first-page":"998-1001","DOI":"10.1126\/science.1251178","article-title":"Labor market returns to an early childhood stimulation intervention in Jamaica.","volume":"344","author":"P Gertler","year":"2014","journal-title":"Science."}],"container-title":["Wellcome Open Research"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/wellcomeopenresearch.org\/articles\/9-486\/v2\/xml","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/wellcomeopenresearch.org\/articles\/9-486\/v2\/pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/wellcomeopenresearch.org\/articles\/9-486\/v2\/iparadigms","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,1,28]],"date-time":"2025-01-28T06:15:18Z","timestamp":1738044918000},"score":1,"resource":{"primary":{"URL":"https:\/\/wellcomeopenresearch.org\/articles\/9-486\/v2"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,11,22]]},"references-count":107,"URL":"https:\/\/doi.org\/10.12688\/wellcomeopenres.22817.2","relation":{"has-version":[{"id-type":"doi","id":"10.12688\/wellcomeopenres.22817.1","asserted-by":"subject"}],"has-review":[{"id-type":"doi","id":"10.21956\/wellcomeopenres.25783.r112955","asserted-by":"subject"},{"id-type":"doi","id":"10.21956\/wellcomeopenres.25783.r112955","asserted-by":"object"}]},"ISSN":["2398-502X"],"issn-type":[{"value":"2398-502X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,11,22]]},"assertion":[{"value":"Indexed","URL":"https:\/\/wellcomeopenresearch.org\/articles\/9-486\/v2#article-reports","order":0,"name":"referee-status","label":"Referee status","group":{"name":"current-referee-status","label":"Current Referee Status"}},{"value":"10.21956\/wellcomeopenres.25783.r112955, Beena Koshy, Christian Medical College, Vellore, 28 Jan 2025, version 2, indexed","URL":"https:\/\/wellcomeopenresearch.org\/articles\/9-486\/v2#referee-response-112955","order":0,"name":"referee-response-112955","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"10.21956\/wellcomeopenres.25123.r97652, Esther Walton, University of Bath, Bath, 02 Oct 2024, version 1, 1 approved, 1 approved with reservations","URL":"https:\/\/wellcomeopenresearch.org\/articles\/9-486\/v1#referee-response-97652","order":1,"name":"referee-response-97652","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"<b>Debarati Mukherjee<\/b>; \n<i>Posted: 19 Nov 2024<\/i>; \n<b><u>Response to reviewer comments - Reviewer 2<\/u><\/b> \n<b>This is an excellent protocol for the COINCIDE study, providing very detailed yet clear information on the aims, design, measures and key research questions of the study.<\/b> \n<b>Data collection across two regions with different demographic characteristics, with linkage to previous data collected in these samples, is a key strength of the proposed work. The selection criteria are clearly laid out. I also appreciate the collection of biological and both quantitative and qualitative data. Figure 2 describes the planned activities very clearly.<\/b> \n<b>Response<\/b>: Thank you very much for your insightful and supportive review of our paper. We deeply appreciate your encouraging comments and are grateful for your constructive suggestions, which will enhance the clarity and impact of our work. We are truly grateful for your time and effort in reviewing our manuscript. We have provided a detailed point-wise response to each of your comments, including updated page numbers in the revised manuscript, where the changes can be viewed (V2). &nbsp;  \n<b><u>I recommend clarifying the following:<\/u><\/b>  \n<b>While it is mentioned that biological samples will be collected for genetic and epigenetic assessments, this is not included in Table 4. Is the plan to collect samples but not process them until later?<\/b> \n<b>Response:<\/b> Many thanks for this keen observation. As mentioned towards the end of our \u201cIntroduction\u201d section (now under \u201cSpecific aims and hypotheses\u201d section) we will be collecting biological samples for a range of analyses. Table 4 specifically includes the plans for the COINCIDE study, such as collection and processing of stored plasma and serum samples to measure biomarkers of micronutrients and heavy metals. The genetic, epigenetic, biochemical, and metabolomic assessments are part of our future plans. These analyses are beyond the scope of the current study, but collecting these samples will allow for their use in longitudinal analyses in future studies aimed at identifying novel biomarkers of child development during middle- and late-childhood, thereby maximizing the value of these data. &nbsp;  \n<b>The Machine Learning section is arguable a bit brief. If space allowed, the authors could add more details, for example on how the training and testing samples will be split\/defined.<\/b> \n<b>Response: Thank you for your suggestion. We have now included the following in the main text as well:<\/b> \n<i>\u201cWe will develop a machine learning-based model to predict children\u2019s cognitive, academic achievement, and mental health outcomes (scores based on direct child assessments and questionnaire-based tools) against predictor variables from the psychosocial, nutritional, and environmental domains. We will split the dataset for each study setting into training (70%) and validation (30%) datasets. Tree-based models are useful to model non-linearities and interactions between variables and would be our primary choice of algorithms. Random forests and gradient boosting models will be developed with internal cross-validation to tune the hyperparameters. Predictions from these algorithms on the validation dataset will be evaluated using measures of prediction accuracy such as R2 and root mean squared errors (RMSE).\u201d<\/i> Please let us know if this level of detail is adequate for this protocol paper. We will be happy to furnish additional details if requested. The main manuscript which describes this data-driven approach will have a dedicated methods section which will provide a detailed description of the machine learning models and methods used to predict children\u2019s outcomes. &nbsp;  \n<b>I wondered whether more child self-reports could be included in this study. Most measures will be obtained using parental reports, but certain mental health traits (such as depression and other internalizing symptoms) can sometimes be better ascertained using self-reports.<\/b> \n<b>Response:<\/b> We had the opportunity to pilot two child-reported questionnaires in older children (8-9-years-old; N = 32) in the SPRING cohort before the second sweep of data collection commenced. These were the Revised Child Anxiety and Depression Scale (RCADS) (47 items) and Revised Child and Youth Resilience Measurement (R-CYRM) (17 items). The parent-report versions of these questionnaires were simultaneously administered to children\u2019s mothers by clinical psychologists. Based on the observations of the clinical psychologists and a senior research team member, the team took a decision \n<b>to not to use the child-reported questionnaires <\/b>for the following reasons:  \n<i>Challenges in children's comprehension of questionnaire items:<\/i> In the rural Rewari setting, children found it difficult to understand most of the questions. It was particularly challenging for them to understand the concepts of anxiety, obsessive compulsive disorder (OCD), and bad thoughts. Even with detailed explanations, they remained confused, and tended to select the same response option throughout the assessment. \n<i>Assessment fatigue:<\/i> The lengthy questionnaire, especially the 47-item RCADS questionnaire, proved to be a significant assessment burden for children in this setting. This affected their responses, which could also have contributed to them consistently choosing the same response option, regardless of the question. \n<i>Higher quality of parental (largely mothers) responses observed for the same questionnaires: <\/i>The supervision team agreed that parents found it easier to comprehend the questionnaire items when explanations were provided, resulting in more varied and potentially more appropriate responses. Since the parent-reported questionnaires were expected to yield higher quality data, the team made a decision to only proceed with the latter. Child reported questionnaires will be attempted in both the cohorts when children are older in future studies.  \n<b>I could not find who's funding this study (or previous waves of data collection).<\/b> \n<b>Response: <\/b>This work was supported by the DBT\/Wellcome Trust India Alliance [IA\/TSG\/20\/1\/600023]. The urban MAASTHI birth cohort was established and followed up from 2016-2019 through funding by the DBT\/Wellcome Trust India Alliance as an Intermediate fellowship awarded to Prof. Giridhara R. Babu. The rural SPRING cohort was funded from 2013-2018 by a Wellcome Trust Programme grant (0936115\/Z\/10\/Z), followed by the Corporate Social Responsibility initiative of Madura Microfinance Ltd. from 2017- 2021 for a study aimed to develop the DEEP tool\n<sup>1-3<\/sup> ) through a study titled Integrated Assessment of Cognitive Development (REACH). &nbsp; \n<b>In summary, this is a comprehensive description of a new ambitious study in India that aims to shed light into the nutritional, psychosocial, and environmental determinants of child mental health.<\/b> \n<b>Response:<\/b> Thank you again for your detailed review. Your expertise has helped us refine our protocol paper.  \n<b>References:<\/b> 1. Bhavnani S, Ranjan A, Mukherjee D, et al. A non-specialist worker delivered digital assessment of cognitive development (DEEP) in young children: a longitudinal validation study in rural India. \n<i>medRxiv<\/i> 2024: 2024.11. 04.24316724. 2. Bhavnani S, Mukherjee D, Bhopal S, et al. The association of a novel digital tool for assessment of early childhood cognitive development, 'DEvelopmental assessment on an E-Platform (DEEP)', with growth in rural India: A proof of concept study. \n<i>EClinicalMedicine<\/i> 2021; \n<b>37<\/b>: 100964. 3.&nbsp; Mukherjee D, Bhavnani S, Swaminathan A, et al. Proof of Concept of a Gamified DEvelopmental Assessment on an E-Platform (DEEP) Tool to Measure Cognitive Development in Rural Indian Preschool Children. \n<i>Front Psychol<\/i> 2020; \n<b>11<\/b>: 1202.","URL":"https:\/\/wellcomeopenresearch.org\/articles\/9-486\/v2#referee-comment-5920","order":2,"name":"referee-comment-5920","label":"Referee Comment","group":{"name":"article-reports","label":"Article Reports"}},{"value":"This work was supported by the DBT\/Wellcome Trust India Alliance [IA\/TSG\/20\/1\/600023]. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.","order":3,"name":"grant-information","label":"Grant Information"},{"value":"This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.","order":0,"name":"copyright-info","label":"Copyright"}]}}