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INTRODUCTION Folate one carbon (1C) transfers, present ubiquitously in every cell in the body, are key components of cell metabolism. They are involved in the transfer of methyl groups for [...], BACKGROUND/OBJECTIVES: Multi-nutrient insufficiencies as a consequence of nutritional and economic factors are common in India and other developing countries. We have examined the impact of multi-nutrient insufficiency on markers of one carbon (1C) metabolism in the blood, and response to a methionine load in clinically healthy young women. SUBJECTS/METHODS: Young women from Pune, India (n = 10) and Cleveland, USA (n = 13) were studied. Blood samples were obtained in the basal state and following an oral methionine load (50 mg/kg of body weight in orange juice). Plasma concentrations of vitamin B12, folate and B6 were measured in the basal state. The effect of methionine load on the levels of methionine, total homocysteine, cysteine, glutathione and amino acids was examined. RESULTS: Indian women were significantly shorter and lighter compared with the American women and had lower plasma concentration of vitamins B12, folate and B6, essential amino acids and glutathione, but higher concentration of total homocysteine. The homocysteine response to methionine load was higher in Indian women. The plasma concentrations of glycine and serine increased in the Indian women after methionine (in juice) load. A significant negative correlation between plasma B6 and homocysteine (r = - 0.70), and plasma folate and glycine and serine levels were observed in the Indian group (P < 0.05) but not in the American group. CONCLUSIONS: Multi-nutrient insufficiency in the Indian women caused unique changes in markers of whole body protein and 1C metabolism. These data would be useful in developing nutrient intervention strategies. European Journal of Clinical Nutrition (2016) 70, 687-693; doi: 10.1038/ejcn.2015.155; published online 16 September 2015

Insufficiency of vitamin B12 (B12) and folate during pregnancy can result in low concentrations in the fetus and have adverse effects on brain development. We investigated the relationship between maternal B12 and folate nutrition during pregnancy and offspring motor, mental and social development at two years of age (2 y). Mothers (n = 123) and their offspring (62 girls, 61 boys) from rural and middle-class urban communities in and around Pune city were followed through pregnancy up to 2 y. Maternal B12 and folate concentrations were measured at 28 and 34 weeks of gestation. At 2 y, the Developmental Assessment Scale for Indian Infants was used to determine motor and mental developmental quotients and the Vineland Social Maturity Scale for the social developmental quotient. Overall, 62% of the mothers had low B12 levels (<150 pmol/l) and one mother was folate deficient during pregnancy. Maternal B12 at 28 and 34 weeks of gestation was associated with offspring B12 at 2 y (r = 0.29, r = 0.32, P < 0.001), but folate was not associated with offspring folate. At 2 y, motor development was associated with maternal folate at 28 and 34 weeks of gestation. Mental and social development quotients were associated positively with head circumference and negatively with birth weight. In addition, pregnancy B12 and folate were positively associated with mental and social development quotients. Maternal B12 and folate during intrauterine life may favorably influence brain development and function. Pregnancy provides a window of opportunity to enhance fetal psychomotor (motor and mental) development. [ABSTRACT FROM PUBLISHER]

Longitudinal studies investigating vitamin B12 and folate status of mothers and their offspring will provide a better understanding of intergenerational nutrition. During pregnancy and 2 years (2y) after delivery, we measured plasma vitamin B12 and folate concentrations in 118 women [aged (mean ± s.d.) 22.9 ± 3.9y] who attended a rural (n = 68) or an urban (n = 50) antenatal clinic in Pune, India. Cord blood vitamin B12 and folate were measured, and when the child was 2y total homocysteine (tHcy) was also measured. Demographic and diet measurements were recorded using standard methods.Pregnancy plasma vitamin B12 concentration at 34 weeks was low [median (25th, 75th), 115 (95, 147) pm]; 75% had low status (<150 pm). Plasma folate was high (mean ± s.d., 33 ± 21 nm); one had a folate concentration <7 pm. Cord plasma vitamin B12 and folate concentrations were higher than and positively associated with maternal concentrations. In stepwise regression, higher child vitamin B12 at 2y was predicted (total R2 15.7%) by pregnancy vitamin B12 (std β 0.201, R2 7.7%), current consumption of cow's milk (std β 0.194, R2 3.3%) and whether breast feeding was stopped before 2y (std β −0.234 R2 7.2%). Child's 2y tHcy concentration was high (11.4 ± 3.6 μm) and predicted by lower pregnancy vitamin B12 (std β −0.206, R2 4.1%), lack of vitamin supplementation (std β −0.256, R2 5.6%) in pregnancy and whether currently breastfed (std β 0.268, R2 8.4%).Low maternal vitamin B12 status in pregnancy and prolonged breast-feeding results in disturbed one-carbon metabolism in offspring at 2y. Supplementation of women of child-bearing age, particularly during pregnancy and lactation, may improve the homocysteine status of these children. [ABSTRACT FROM PUBLISHER]

Background/Objectives:Vitamin B12 (B12) deficiency is common in Indians and a major contributor to hyperhomocysteinemia, which may influence fetal growth, risk of type II diabetes and cardiovascular disease. The purpose of this paper was to study the effect of physiological doses of B12 and folic acid on plasma total homocysteine (tHcy) concentration.Subjects/Methods:A cluster randomized, placebo-controlled, double-blind, 2 × 3 factorial trial, using the family as the randomization unit. B12 was given as 2 or 10 μg capsules, with or without 200 μg folic acid, forming six groups (B0F0, B2F0, B10F0, B0F200, B2F200 and B10F200). Plasma tHcy concentration was measured before and after 4 and 12 months of supplementation.Results:From 119 families in the Pune Maternal Nutrition Study, 300 individuals were randomized. There was no interaction between B12 and folic acid (P=0.14) in relation to tHcy concentration change and their effects were analyzed separately: B0 vs. B2 vs. B10; and F0 vs. F200. At 12 months, tHcy concentration reduced by a mean 5.9 (95% CI: −7.8, −4.1) μmol/l in B2, and by 7.1 (95% CI: −8.9, −5.4) μmol/l in B10, compared to nonsignificant rise of 1.2 (95% CI: −0.5, 2.9) μmol/l in B0. B2 and B10 did not differ significantly. In F200, tHcy concentration decreased by 4.8 (95% CI: −6.3, −3.3) μmol/l compared to 2.8 (95% CI: −4.3, −1.2) μmol/l in F0.Conclusion:Daily oral supplementation with physiological doses of B12 is an effective community intervention to reduce tHcy. Folic acid (200 μg per day) showed no additional benefit, neither had any unfavorable effects. [ABSTRACT FROM AUTHOR]

Raised maternal plasma total homocysteine (tHcy) concentrations predict small size at birth, which is a risk factor for type 2 diabetes mellitus. We studied the association between maternal vitamin B12, folate and tHcy status during pregnancy, and offspring adiposity and insulin resistance at 6 years. In the Pune Maternal Nutrition Study we studied 700 consecutive eligible pregnant women in six villages. We measured maternal nutritional intake and circulating concentrations of folate, vitamin B12, tHcy and methylmalonic acid (MMA) at 18 and 28 weeks of gestation. These were correlated with offspring anthropometry, body composition (dual-energy X-ray absorptiometry scan) and insulin resistance (homeostatic model assessment of insulin resistance [HOMA-R]) at 6 years. Two-thirds of mothers had low vitamin B12 (<150 pmol/l), 90% had high MMA (>0.26 μmol/l) and 30% had raised tHcy concentrations (>10 μmol/l); only one had a low erythrocyte folate concentration. Although short and thin (BMI), the 6-year-old children were relatively adipose compared with the UK standards (skinfold thicknesses). Higher maternal erythrocyte folate concentrations at 28 weeks predicted higher offspring adiposity and higher HOMA-R (both p < 0.01). Low maternal vitamin B12 (18 weeks; p = 0.03) predicted higher HOMA-R in the children. The offspring of mothers with a combination of high folate and low vitamin B12 concentrations were the most insulin resistant. Low maternal vitamin B12 and high folate status may contribute to the epidemic of adiposity and type 2 diabetes in India. [ABSTRACT FROM AUTHOR]

Presents a letter to the editor about women with gestational diabetes mellitus in India.

Background: Environmental factors influence children's development. However, their impact on outdoor play among children from international settings remains understudied. This study examined associations between parent perceptions of environmental factors and outdoor play among an international sample of preschool-aged children., Methods: Data were sourced from the pilot phases of the SUNRISE International Study of Movement Behaviors in the Early Years. Parents completed a questionnaire about their child's outdoor play and environmental factors that influenced their child's participation in outdoor play in the past 3 days., Results: 1855 children from 19 countries (16 low- and middle-income countries) were examined. Heat (-25.6; 95% CI, -44.6 to -6.6), cold (-26.9; 95% CI, -45.9 to -8.4), and rain (-24.8; 95% CI, -43.3 to -6.6) were negatively associated with weekday outdoor play. Cold (-41.2; 95% CI, -62.4 to -20.0) and social instability (-40.7; 95% CI, -61.5 to -20.3) were negatively associated with weekend outdoor play. Playing at friend's or relative's homes (29.5 [95% CI, 18.6 to 40.5]; 37.9 [25.6 to 50.4]), greenspaces (23.1 [95% CI, 9.6 to 36.6]; 30.4 [95% CI, 15.1 to 45.8]), and on the street (41.4 [95% CI, 26.9 to 55.7]; 34.9 [95% CI, 18.2 to 51.3]) were associated with weekday and weekend day outdoor play, respectively. Playing on the family's property was also associated with weekend day outdoor play (25.5 [95% CI, 18.2 to 51.3])., Conclusions: The environmental context is important to consider when developing interventions to promote outdoor play in young children across diverse international settings. Future research from representative populations is needed to confirm these findings.

Study Objectives: To examine 1) multidimensional sleep profiles in pre-schoolers (3-6 years) across geocultural regions and 2) differences in sleep characteristics and family practices between Majority World regions (Pacific Islands, Sub-Saharan Africa, Eastern Europe, Northeast Asia, Southeast Asia, South Asia, the Middle East and North Africa, Latin America) and the Minority World (the Western world)., Methods: Participants were 3507 pre-schoolers from 37 countries. Nighttime sleep characteristics and nap duration (accelerometer: n=1950) and family practices (parental questionnaire) were measured. Mixed models were used to estimate the marginal means of sleep characteristics by region and examine the differences., Results: Geocultural region explained up to 30% of variance in sleep characteristics. A pattern of short nighttime sleep duration, low sleep efficiency, and long nap duration was observed in Eastern Europe, Northeast Asia, and Southeast Asia. The second pattern, with later sleep midpoints and greater night-to-night sleep variability, was observed in South Asia, the Middle East and North Africa, and Latin America. Compared to the Minority World, less optimal sleep characteristics were observed in several Majority World regions, with medium-to-large effect sizes (∣d∣=0.48-2.35). Several Majority World regions reported more frequent parental smartphone use during bedtime routines (Northeast Asia, Southeast Asia: 0.77-0.99 units) and were more likely to have electronic devices in children's bedroom (Eastern Europe, Latin America, South Asia: OR=5.97-16.57) and co-sleeping arrangement (Asia, Latin America: OR=7.05-49.86), compared to the Minority World., Conclusions: Pre-schoolers' sleep profiles and related family practices vary across geocultural regions, which should be considered in sleep health promotion initiatives and policies., (© The Author(s) 2024. Published by Oxford University Press on behalf of Sleep Research Society.)

Importance: The prevalence estimates of physical activity, sedentary behavior, and sleep (collectively known as movement behaviors) in 3- and 4-year-old children worldwide remains uncertain., Objective: To report the proportion of 3- and 4-year-old children who met the World Health Organization guidelines for physical activity, sedentary behavior, and sleep across 33 countries., Design, Setting, and Participants: Pooled analysis of data from 14 cross-sectional studies (July 2008 to September 2022) identified through systematic reviews and personal networks. Thirty-three countries of varying income levels across 6 geographical regions. Each study site needed to have at least 40 children aged 3.0 to 4.9 years with valid accelerometry and parent-/caregiver-reported screen time and sleep duration data. Data were analyzed from October 2022 to February 2023., Exposures: Time spent in physical activity was assessed by reanalyzing accelerometry data using a harmonized data-processing protocol. Screen time and sleep duration were proxy reported by parents or caregivers., Main Outcomes and Measures: The proportion of children who met the World Health Organization guidelines for physical activity (≥180 min/d of total physical activity and ≥60 min/d of moderate- to vigorous-intensity physical activity), screen time (≤1 h/d), and sleep duration (10-13 h/d) was estimated across countries and by World Bank income group and geographical region using meta-analysis., Results: Of the 7017 children (mean [SD] age, 4.1 [0.5] years; 3585 [51.1%] boys and 3432 [48.9%] girls) in this pooled analysis, 14.3% (95% CI, 9.7-20.7) met the overall guidelines for physical activity, screen time, and sleep duration. There was no clear pattern according to income group: the proportion meeting the guidelines was 16.6% (95% CI, 10.4-25.3) in low- and lower-middle-income countries, 11.9% (95% CI, 5.9-22.5) in upper-middle-income countries, and 14.4% (95% CI, 9.6-21.1) in high-income countries. The region with the highest proportion meeting the guidelines was Africa (23.9%; 95% CI, 11.6-43.0), while the lowest proportion was in North and South America (7.7%; 95% CI, 3.6-15.8)., Conclusions and Relevance: Most 3- and 4-year-old children in this pooled analysis did not meet the current World Health Organization guidelines for physical activity, sedentary behavior, and sleep. Priority must be given to understanding factors that influence these behaviors in this age group and to implementing contextually appropriate programs and policies proven to be effective in promoting healthy levels of movement behaviors.

Competing Interests: There are no conflicts of interest.

Background Poor nutritional status may lead to longer hospital stays, increased mortality and morbidity, increased cost, and higher suffering. Nosocomial infections (NI) are a global health concern, and several risk factors are associated with their higher incidence. This study aimed to reveal that compromised nutritional status is one of the risk factors for developing NIs. Methodology The study was conducted in a tertiary care hospital in Pune, India. This was a prospective cohort study with a sample size of 200 hospitalized participants. Data collection was based on standard tools and structured forms which had two parts. In the first part, the assessment of nutritional status was done for which patients were categorized into two groups, namely, well-nourished and undernourished. Additionally, biochemical parameters (serum albumin) were also assessed. The second part included a follow-up of participants to evaluate the development of NIs including their laboratory investigation. Results were analyzed statistically using R software. Results Among 200 participants, 60 were female, of whom 15% developed NIs. Of the 140 males, 8% had NIs. Among 200 participants, 101 (51%) were well-nourished, of whom two (2%) developed NIs. Of the 99 (49%) undernourished participants, 18 (18%) had NIs. Those who were undernourished (univariate relative risk = 6.10, 95% confidence interval) were more prone to developing NIs compared to the well-nourished group. Conclusions NIs are widespread globally but are less studied and given less emphasis in developing countries. This study reports various types of NIs along with their incidence in well-nourished and undernourished groups. The incidence of NI observed in this study may reflect the higher severity of illness, age, poor nutritional status, and longer hospital stays. Identifying risk factors that can contribute to developing NI may help in their prevention by maximizing patient safety., Competing Interests: The authors have declared that no competing interests exist., (Copyright © 2023, Gupta et al.)

Background: As a key factor for the prevention of childhood obesity, WHO recommends a specific balance of movement behaviours (ie, physical activity, sedentary behaviour, and sleep) across the 24-h day for children younger than 5 years. Substantial evidence underpins our understanding of the benefits for healthy growth and development; however, little is known about young children's experiences and perceptions, and whether context-specific factors that might influence movement behaviours differ across the globe., Methods: Acknowledging children's agency as knowledgeable informants on matters affecting their lives, children aged 3-5 years from communities and preschools in urban and rural Australia, Chile, China, India, Morocco, and South Africa, were interviewed. Discussions were based on a socioecological framework of the multifactorial, complex influences on young children's movement behaviours. Prompts were adapted to ensure relevance across diverse study sites. Ethics approval and guardian consent were obtained, and the Framework Method used for analysis., Findings: 156 children (101 [65%] from urban areas, 55 [45%] from rural areas; 73 [47%] female, 83 [53%] male) shared their experiences, perceptions, and preferences related to movement behaviours and the barriers and enablers of outdoor play. Physical activity, sedentary behaviour, and to a lesser degree screen time occurred predominantly through play. Barriers to outdoor play included weather, air quality, and safety concerns. Sleep routines varied considerably and were influenced by room or bed sharing. Screen use was ubiquitous, presenting a challenge to meeting recommendations. The effect of daily structure, degree of autonomy, and interactions were consistent themes, and differences in how these factors influenced movement behaviours across study sites were evident., Interpretation: The findings highlight that although movement behaviour guidelines are universal, contextual realities need to be considered in how socialisation and promotion of the guidelines are enacted. How young children's sociocultural and physical environments are constructed and influenced can foster or disrupt healthy movement behaviours, which might have implications for childhood obesity., Funding: Beijing High Level Talents Cultivation Project for Public Health Academic Leader; Beijing Medical Research Institute (Public service development and reform pilot project); British Academy for the Humanities and Social Sciences; KEM Hospital Research Centre; Ministry of Education and Universidad de La Frontera (Innovation in Higher Education Program); and National Health and Medical Research Council (Investigator Grant Leadership Fellow, Level 2)., (Copyright © 2023 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Maternal size, weight gain in pregnancy, fetal gender, environment and gestational age are known determinants of birth weight. It is not clear which component of maternal weight or gained weight during pregnancy influences birth weight. We evaluated the association of maternal total body water measured by the deuterium dilution technique (TBW-D 2 O) at 17 and 34 weeks of gestation with birth weight. A secondary aim was to examine the utility of bioimpedance spectroscopy (BIS) to determine total body water (TBW-BIS) in pregnancy. At 17 and 34 weeks of pregnancy, ninety-nine women (fifty-one rural and forty-eight urban) from Pune, India had measurements of body weight, TBW-D 2 O, TBW-BIS and offspring birth weight. At 17 weeks of gestation, average weights for rural and urban women were 45⋅5 ± 4⋅8 (sd) and 50⋅7 ± 7⋅8 kg ( P < 0⋅0001), respectively. Maternal weight gains over the subsequent 17 weeks for rural and urban women were 6⋅0 ± 2⋅2 and 7⋅5 ± 2⋅8 kg ( P = 0⋅003) and water gains were 4⋅0 ± 2⋅4 and 4⋅8 ± 2⋅8 kg ( P = 0⋅092), respectively. In both rural and urban women, birth weight was positively, and independently, associated with gestation and parity. Only for rural women, between 17 and 34 weeks, was an increase in dry mass (weight minus TBW-D 2 O) or a decrease in TBW-D 2 O as a percentage of total weight associated with a higher birth weight. At both 17 and 34 weeks, TBW-BIS increasingly underestimated TBW-D 2 O as the water space increased. Differences in body composition during pregnancy between rural and urban environments and possible impacts of nutrition transition on maternal body composition and fetal growth were demonstrated., (© The Author(s) 2022.)

Competing Interests: Disclosure of interest: The authors completed the ICMJE Disclosure of Interest Form (available upon request from the corresponding author) and declare no relevant interest.

Background: Dietary vitamin B 12 (B 12 ) deficiency is common in Indians. Long-term compliance to tablet supplementation is poor in asymptomatic individuals., Objective: To study efficacy of B 12 fortified nutrient bar and yogurt in improving plasma B 12 concentrations in children and adults., Methods: Two double-blind, placebo-controlled directly observed therapy randomized controlled trials were conducted for 120 days: (1) Healthy children (10-13 years) were fed nutrient bar fortified with B 12 (2 μg), multiple micronutrients B 12 (1.8 μg) or placebo. (2) Healthy adults (18-50 years) were fed yogurt fortified with B 12 (2 μg) or Propionibacterium (1 × 10 8 cfu/g) or placebo. B 12 , folate, homocysteine, and hemoglobin concentrations were measured before and post intervention., Results: We randomized 164 children and 118 adults; adherence was 96% and 82%, respectively. In children, B 12 fortified bars increased B 12 concentrations significantly above baseline (B 12 alone +91 pmol/L, B 12 + multiple micronutrients +82 pmol/L) compared to placebo. In adults, B 12 fortified yogurt increased B 12 significantly (+38 pmol/L) but Propionibacterium and placebo did not. In both trials, homocysteine fell significantly with B 12 supplementation. Rise of B 12 and fall of homocysteine were influenced by dose of B 12 and folic acid. There was no significant difference in change of anthropometry and hemoglobin between groups., Conclusions: B 12 fortified foods are effective in improving B 12 status in Indian children and adults. They could be used to improve B 12 status in the national programs for children, adolescents, and women of reproductive age. They could also be used as over-the-counter products.

Introduction: 24-hour movement behaviours (physical activity, sedentary behaviour and sleep) during the early years are associated with health and developmental outcomes, prompting the WHO to develop Global guidelines for physical activity, sedentary behaviour and sleep for children under 5 years of age. Prevalence data on 24-hour movement behaviours is lacking, particularly in low-income and middle-income countries (LMICs). This paper describes the development of the SUNRISE International Study of Movement Behaviours in the Early Years protocol, designed to address this gap., Methods and Analysis: SUNRISE is the first international cross-sectional study that aims to determine the proportion of 3- and 4-year-old children who meet the WHO Global guidelines. The study will assess if proportions differ by gender, urban/rural location and/or socioeconomic status. Executive function, motor skills and adiposity will be assessed and potential correlates of 24-hour movement behaviours examined. Pilot research from 24 countries (14 LMICs) informed the study design and protocol. Data are collected locally by research staff from partnering institutions who are trained throughout the research process. Piloting of all measures to determine protocol acceptability and feasibility was interrupted by COVID-19 but is nearing completion. At the time of publication 41 countries are participating in the SUNRISE study., Ethics and Dissemination: The SUNRISE protocol has received ethics approved from the University of Wollongong, Australia, and in each country by the applicable ethics committees. Approval is also sought from any relevant government departments or organisations. The results will inform global efforts to prevent childhood obesity and ensure young children reach their health and developmental potential. Findings on the correlates of movement behaviours can guide future interventions to improve the movement behaviours in culturally specific ways. Study findings will be disseminated via publications, conference presentations and may contribute to the development of local guidelines and public health interventions., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Micronutrient deficiency is a known cause of adverse neurodevelopment and growth. Poor adherence to oral regimes of micronutrient supplements is a known challenge during the implementation of supplementation programs. The present study evaluates the benefits of liposomal encapsulated micronutrient fortified body oils (LMF oil) that can be used for infant body massage in terms of neurodevelopment and prevention of deficiency., Study Design: Double-blind randomized clinical trial., Methods: A total of 444 healthy infants aged 4-7 weeks were randomized to receive either LMF oil (containing iron, vitamin D, folate, and vitamin B12) or placebo oil for gentle body massage till 12 months of age. Blood samples were collected at 6 and 12 months for transferrin saturation (TSAT), hemoglobin, and 25-hydroxy vitamin (25-OH-D) levels. Mental and motor development was assessed at 12 months using developmental assessment for Indian Infants (DASII)., Results: A total of 391 infants completed the study. There was no significant improvement in the hemoglobin in the intervention group at 12 months of age as compared to the placebo group [- 0.50 vs.-0.54 g%]. There was a marginally significant improvement in 25-OH-D at 12 months in the LMF oil group [+ 1.46vs.-0.18 ng/ml, p = 0.049]. In the subgroup of infants with moderate anemia, the intervention prevented the decline in hemoglobin at 12 months of age [adjusted mean change + 0.11vs.-0.51 g%, p = 0.043]. The mental or motor developmental quotients in the intervention group were not significantly different from those in the placebo group., Conclusion: Use of LMF oil for prevention of nutritional deficiency did not offer significant protection against nutritional anemia but prevented vitamin D deficiency to some extent with improvement in 25-OH-D at 12 months. In the subgroup of infants with moderate anemia, the intervention prevented the decline in hemoglobin at 12 months of age. The intervention did not result in significant improvement in mental or motor development. Further evaluation with increased doses needs to be undertaken., Trial Registration: CTRI no: CTRI/2017/11/010710 ; dated 30/11/2017., (© 2021. The Author(s).)

This paper describes unique challenges faced during conduct of community research studies in rural population of Maharashtra at Vadu Rural Health Program, Pune, India. Some of the ethical issues faced include difficulty in comprehending the informed consent by rural families with low education levels and ensuring adequate compensation for study participation without undue inducement, ensuring large number of recruitments during early infancy, ensuring adherence to intervention by care-providers, retention of participants especially in studies having long follow-ups and regulatory compliance for serious adverse event reports are major operational challenges. The delays faced in approvals from the Health Ministry Screening Committee and lack of specific regulatory guidance on community-based conduct of studies pose challenges in terms of study timelines and operational aspect of these studies. Provision of study-related information during prestudy visits, designing patient information sheets in simple language, involving the decision-making member of the family, adequate time for families for decision-making are certain measures that have been useful for effective informed consent administration. Collaboration with accredited social health activists and auxillary nurse midwives for line-listing of pregnancies and births and regular conduction of prestudy visits or community sensitization meetings have been useful for the recruitment of large number of study participants during infancy. Strategies such as provision of universal immunization, selection of field research assistants from the local population, regular home visits, and provision of medical care has been helpful in retention of the study participants. Networking with local health facilities and local government bodies has helped in the provision of medical care to the study participants and in the management of serious adverse events. Our experience can provide important learnings to other investigators from developing countries working in the domain of child health., Competing Interests: There are no conflicts of interest., (Copyright: © 2021 Perspectives in Clinical Research.)

Our objective was to investigate associations of body size (birth weight and body mass index (BMI)) and growth in height, body fat (adiposity) and lean mass during childhood and adolescence, with risk markers for diabetes in young South Asian adults. We studied 357 men and women aged 21 years from the Pune Children's Study birth cohort. Exposures were 1) birth weight, 21-year BMI, both of these mutually adjusted, and their interaction, and 2) uncorrelated conditional measures of growth in height and proxies for gain in adiposity and lean mass from birth to 8 years (childhood) and 8 to 21 years (adolescence) constructed from birth weight, and weight, height, and skinfolds at 8 and 21 years. Outcomes were plasma glucose and insulin concentrations during an oral glucose tolerance test and derived indices of insulin resistance and secretion. Higher 21-year BMI was associated with higher glucose and insulin concentrations and insulin resistance, and lower disposition index. After adjusting for 21-year BMI, higher birth weight was associated with lower 120-min glucose and insulin resistance, and higher disposition index. In the growth analysis, greater adiposity gain during childhood and adolescence was associated with higher glucose, insulin and insulin resistance, and lower disposition index, with stronger effects from adolescent gain. Greater childhood lean gain and adolescent height gain were associated with lower 120-min glucose and insulin. Consistent with other studies, lower birth weight and higher childhood weight gain increases diabetes risk. Disaggregation of weight gain showed that greater child/adolescent adiposity gain and lower lean and height gain may increase risk.

Background: The restrictions associated with the 2020 COVID-19 pandemic has resulted in changes to young children's daily routines and habits. The impact on their participation in movement behaviours (physical activity, sedentary screen time and sleep) is unknown. This international longitudinal study compared young children's movement behaviours before and during the COVID-19 pandemic., Methods: Parents of children aged 3-5 years, from 14 countries (8 low- and middle-income countries, LMICs) completed surveys to assess changes in movement behaviours and how these changes were associated with the COVID-19 pandemic. Surveys were completed in the 12 months up to March 2020 and again between May and June 2020 (at the height of restrictions). Physical activity (PA), sedentary screen time (SST) and sleep were assessed via parent survey. At Time 2, COVID-19 factors including level of restriction, environmental conditions, and parental stress were measured. Compliance with the World Health Organizations (WHO) Global guidelines for PA (180 min/day [≥60 min moderate- vigorous PA]), SST (≤1 h/day) and sleep (10-13 h/day) for children under 5 years of age, was determined., Results: Nine hundred- forty-eight parents completed the survey at both time points. Children from LMICs were more likely to meet the PA (Adjusted Odds Ratio [AdjOR] = 2.0, 95%Confidence Interval [CI] 1.0,3.8) and SST (AdjOR = 2.2, 95%CI 1.2,3.9) guidelines than their high-income country (HIC) counterparts. Children who could go outside during COVID-19 were more likely to meet all WHO Global guidelines (AdjOR = 3.3, 95%CI 1.1,9.8) than those who were not. Children of parents with higher compared to lower stress were less likely to meet all three guidelines (AdjOR = 0.5, 95%CI 0.3,0.9)., Conclusion: PA and SST levels of children from LMICs have been less impacted by COVID-19 than in HICs. Ensuring children can access an outdoor space, and supporting parents' mental health are important prerequisites for enabling pre-schoolers to practice healthy movement behaviours and meet the Global guidelines.

Indian communities have the ancient cultural practice of gentle oil massage for infants which has been shown to play a beneficial role in neuro-motor development. The concept of incorporating nanosized liposomes of micronutrients (i.e., iron, folate, vitamin B12, and vitamin D) in the body oil leverages this practice for transdermal supplementation of essential micro-nutrients. This paper describes the experience of developing an intervention in the form of body oil containing nanosized liposomes of iron and micro-nutrients built on the social context of infant oil massage using a theory of change approach. The process of development of the intervention has been covered into stages such as design, decide and implement. The design phase describes how the idea of nanosized liposomal encapsulated micronutrient fortified (LMF) body oil was conceptualized and how its feasibility was assessed through initial formative work in the community. The decide phase describes steps involved while scaling up technology from laboratory to community level. The implementation phase describes processes while implementing the intervention of LMF oil in a community-based randomized controlled study. Overall, the theory of change approach helps to outline the various intermediate steps and challenges while translating novel technologies for transdermal nutrient fortification to community level. In our experience, adaptation in the technology for large scale up, formative work and pilot testing of innovation at community level were important processes that helped in shaping the innovation. Meticulous mapping of these processes and experiences can be a useful guide for translating similar innovations., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Apte, Lubree, Kapoor, Juvekar, Banerjee and Bavdekar.)

Objectives: We investigated whether the relationship between components of height and cardiovascular disease (CVD) risk may be explained by body composition. We also examined relationships between parental heights and offspring CVD risk., Design: A cohort study using cross-sectional data., Setting: A secondary care hospital setting in Pune, India., Participants: We studied 357 young adults and their parents in the Pune Children's Study. Primary and secondary outcomes: we measured weight, total height, leg length, sitting height, plasma glucose, insulin and lipids, and blood pressure (BP). Total and regional lean and fat mass were measured by dual X-ray absorptiometry., Results: Leg length was inversely related, and sitting height was directly related to BMI. Total height and leg length were directly related to lean mass, while sitting height was directly related to both lean and fat mass. Leg length was inversely related to systolic BP and 120 min glucose, independent of lean and fat mass. Sitting height was directly related to systolic BP and triglycerides; these relationships were attenuated on adjustment for lean and fat mass. When examined simultaneously, greater leg length was protective and greater sitting height was associated with a more detrimental CVD risk profile., Conclusions: Shorter adult leg length and greater sitting height are associated with a more adverse CVD risk factor profile. The mechanisms need further study, but our findings suggest a role for lean and fat mass., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.)

The human microbiome plays a key role in maintaining host homeostasis and is influenced by age, geography, diet, and other factors. Traditionally, India has an established convention of extended family arrangements wherein three or more generations, bound by genetic relatedness, stay in the same household. In the present study, we have utilized this unique family arrangement to understand the association of age with the microbiome. We characterized stool, oral and skin microbiome of 54 healthy individuals from six joint families by 16S rRNA gene-based metagenomics. In total, 69 (1.03%), 293 (2.68%) and 190 (8.66%) differentially abundant OTUs were detected across three generations in the gut, skin and oral microbiome, respectively. Age-associated changes in the gut and oral microbiome of patrilineal families showed positive correlations in the abundance of phyla Proteobacteria and Fusobacteria, respectively. Genera Treponema and Fusobacterium showed a positive correlation with age while Granulicatella and Streptococcus showed a negative correlation with age in the oral microbiome. Members of genus Prevotella illustrated high abundance and prevalence as a core OTUs in the gut and oral microbiome. In conclusion, this study highlights that precise and perceptible association of age with microbiome can be drawn when other causal factors are kept constant.