Impact of an integrated health, nutrition, and early child stimulation and responsive care intervention package delivered to preterm or term small for gestational age babies during infancy on growth and neurodevelopment: study protocol of an individually randomized controlled trial in India (Small Babies Trial).

BACKGROUND: Preterm and term small for gestational age (SGA) babies are at high risk of experiencing malnutrition and impaired neurodevelopment. Standalone interventions have modest and sometimes inconsistent effects on growth and neurodevelopment in these babies. For greater impact, intervention may be needed in multiple domains-health, nutrition, and psychosocial care and support. Therefore, the combined effects of an integrated intervention package for preterm and term SGA on growth and neurodevelopment are worth investigating. METHODS: An individually randomized controlled trial is being conducted in urban and peri-urban low to middle-socioeconomic neighborhoods in South Delhi, India. Infants are randomized (1:1) into two strata of 1300 preterm and 1300 term SGA infants each to receive the intervention package or routine care. Infants will be followed until 12 months of age. Outcome data will be collected by an independent outcome ascertainment team at infant ages 1, 3, 6, 9, and 12 months and at 2, 6, and 12 months after delivery for mothers. DISCUSSION: The findings of this study will indicate whether providing an intervention that addresses factors known to limit growth and neurodevelopment can offer substantial benefits to preterm or term SGA infants. The results from this study will increase our understanding of growth and development and guide the design of public health programs in low- and middle-income settings for vulnerable infants. TRIAL REGISTRATION: The trial has been registered prospectively in Clinical Trial Registry - India # CTRI/2021/11/037881, Registered on 08 November 2021.

Use of modern technologies for promoting health at the population level in India.

India, with a population of 1.4 billion, faces health equity challenges due to inaccessible public health systems, particularly in rural areas. Modern technologies like the internet and mobile phones are being used to bridge this gap, enhancing health equity by disseminating vital health information. Health Technology Assessment (HTA) evaluates these technologies, influencing healthcare policy and improving health outcomes. Key strategies include digital health hubs, mobile health units, public-private partnerships, and digital tools for community health workers. To scale these interventions, capacity building, infrastructure development, community engagement, and monitoring are required. Policymakers are urged to prioritize investments in health technologies based on evidence, considering cost-effectiveness, health outcomes, and health equity. Addressing data privacy and security is crucial. Future research should focus on technology-based interventions for maternal and child health.

Daily Folic Acid and/or Vitamin B12 Supplementation Between 6 and 30 Months of Age and Cardiometabolic Risk Markers After 6-7 Years: A Follow-Up of a Randomized Controlled Trial.

BACKGROUND: Deficiencies of vitamin B12 and folate are associated with elevated concentrations of metabolic markers related to CVDs. OBJECTIVES: We investigated the effect of supplementation of vitamin B12 with or without folic acid for 6 mo in early childhood on cardiometabolic risk markers after 6-7 y. METHODS: This is a follow-up study of a 2 × 2 factorial, double-blind, randomized controlled trial of vitamin B12 and/or folic acid supplementation in 6-30-mo-old children. The supplement contained 1.8 µg of vitamin B12, 150 µg of folic acid, or both, constituting >1 AI or recommended daily allowances for a period of 6 mo. Enrolled children were contacted again after 6 y (September 2016-November 2017), and plasma concentrations of tHcy, leptin, high molecular weight adiponectin, and total adiponectin were measured (N = 791). RESULTS: At baseline, 32% of children had a deficiency of either vitamin B12 (<200 pmol/L) or folate (<7.5 nmol/L). Combined supplementation of vitamin B12 and folic acid resulted in 1.19 µmol/L (95% CI: 0.09; 2.30 µmol/L) lower tHcy concentration 6 y later compared to placebo. We also found that vitamin B12 supplementation was associated with a lower leptin-adiponectin ratio in subgroups based on their nutritional status. CONCLUSIONS: Supplementation with vitamin B12 and folic acid in early childhood was associated with a decrease in plasma tHcy concentrations after 6 y. The results of our study provide some evidence of persistent beneficial metabolic effects of vitamin B12 and folic acid supplementation in impoverished populations. The original trial was registered at www. CLINICALTRIALS: gov as NCT00717730, and the follow-up study at www.ctri.nic.in as CTRI/2016/11/007494.

Diet and lifestyle risk factors associated with young adult hypertensives in India - Analysis of National Family Health Survey IV.

Background: Young adults with hypertension have a higher lifetime risk of cardiovascular diseases. Global evidence suggests a significant role of diet and lifestyle risk factors on hypertension among the young adult (aged 18-39 years) hypertensive population. Aim: The purpose of this study was to look for the association of diet and lifestyle risk factors with young adult hypertensives. Results: This study reports the prevalence of young adult hypertension based on a national representative sample based on the National Family Health Survey (NFHS-4) data and the association of behavioral risk factors with young adult hypertension. The survey adopted a two-stage stratified random sampling. The outcome variable was hypertension, whereas the exposure variables were various diet and lifestyle factors. The prevalence of young adult hypertension in India was 12.4% among men and 8.2% among women. Sikkim had the highest prevalence among both sexes. Lower prevalence was seen in the states of Delhi and Kerala. Marital status, body mass index, eating meat, alcohol intake, and taking coffee or tobacco 30 min before BP measurement were found to be associated factors that put both the sexes at risk of developing hypertension. The wealth index was concluded as a risk factor only in men while the level of education came out to be a risk factor only in females. Conclusion: This study is the first from India which gives a recent estimate of prevalence of young adult hypertension by state and individual level characteristics in addition to national level estimates for India.

Tobacco smoking and blood pressure: How are they related among the Indians? - A secondary analysis of National Family Health Survey (NFHS)-4 data.

Background: India, the second leading producer of tobacco, puts the population at a higher chance of tobacco consumption contributing to a significant disease burden. Though tobacco smoking is a modifiable risk factor for hypertension and has been on the rise among the population, studies on the relationship of tobacco with hypertension are limited in India. Aim: This study aimed to assess the population-level risk of tobacco (smoke) use and elevated blood pressure (BP) among Indians and also assess the association of risk of tobacco smoking with hypertension based on the place of residence. Materials and Methods: Data from the National Family Health Survey (NFHS)-4 conducted between January 2015 and December 2016 was utilized. The prevalence of hypertension and its magnitude of association with smoking factors was found using univariable logistic regression. Multivariable logistic regression was performed to predict the association of smoking products with elevated BP by adjusting the model for sociodemographic factors, illness, physical characteristics, and state-wise data. Results: The weighted prevalence of hypertension was 16.56% (confidence interval [CI]: 16.34-16.78) in males and 11.20% (CI: 11.12-11.27) in females. Among those who smoked tobacco, 15.3% women and 22.4% men were hypertensive. This study highlights the significant association of smoking of various tobacco products with hypertension in both men and women on univariate analysis. But the adjusted mean elevated BP among the tobacco-using males and females was not significantly associated with smoking cigarettes, pipe, cigars, and hookah. Conclusion: Cigarette smoking is a modifiable factor for the development and progression of hypertension. Adequate preventive and promotive health measures targeting the young, rural inhabitants and the poorer sections of society may help in reducing tobacco consumption.

Enteral Low-Dose Vitamin A Supplementation in Preterm or Low Birth Weight Infants to Prevent Morbidity and Mortality: a Systematic Review and Meta-analysis.

OBJECTIVES: To assess effects of enteral "low" dose (daily doses of ≤10 000 international unit) vitamin A supplementation compared with no vitamin A supplementation in human milk-fed preterm and low birth weight (LBW) infants. DATA SOURCES: Cochrane Central Register of Controlled Trials; Medline, Embase, Scopus, Web of Science, CINAHL from inception to 16 March 2021. STUDY SELECTION: Randomized trials were screened. Primary outcomes were mortality, morbidity, growth, neurodevelopment. Secondary outcomes were feed intolerance and duration of hospitalization. We also assessed the dose and timing of vitamin A supplementation. Data were extracted and pooled with fixed and random-effects models. RESULTS: Four trials including 800 very LBW <1.5 kg or <32 weeks' gestation infants were found. At latest follow-up, we found little or no effect on: mortality, sepsis, bronchopulmonary dysplasia, retinopathy of prematurity, duration of hospitalisation. However, we found a increased level of serum retinol mean difference of 4.7 µg/ml (95% CI 1.2 to 8.2, I2 =0.00%, one trial, 36 participants,). Evidence ranged from very low to moderate certainty. There were no outcomes reported for length, head circumference or neurodevelopment. LIMITATIONS: Heterogeneity and small sample size in the included studies. CONCLUSIONS: Low-dose vitamin A increased serum retinol concentration among very LBW and very preterm infants but had no effect on other outcomes. More trials are needed to assess effects on clinical outcomes and to assess effects in infants 1.5 to 2.4 kg or 32 to 26 weeks' gestation.

Enteral Iron Supplementation in Preterm or Low Birth Weight Infants: A Systematic Review and Meta-analysis.

BACKGROUND AND OBJECTIVES: Iron is needed for growth and development of infants globally, but preterm and low birth weight (LBW) infants are at risk for severe iron deficiencies. To assess the effect of enteral iron supplementation on mortality, morbidity, growth, and neurodevelopment outcomes in preterm or LBW infants fed human milk. Secondary objectives were to assess the effect on biomarkers and dose and timing. METHODS: Data sources include PubMed, Embase and Cochrane Library databases to March 16, 2021. Study Selection includes controlled or quasi experimental study designs. Two reviewers independently extracted data. RESULTS: Eight trials (eleven reports; 1093 participants, 7 countries) were included. No trials reported mortality. At latest follow-up, there was little effect on infection (very low certainty evidence, 4 studies, 401 participants, relative risk [RR] 0.98, 95% confidence interval [95% CI] 0.56 to 1.73, I2 = 0.00%) and necrotising enterocolitis (3 studies, 375 participants, RR 1.47, 95% CI 0.68 to 3.20, I2 = 0.00%). There was an increase in linear growth (length) (moderate certainty evidence, 3 studies, 384 participants, mean difference 0.69 cm, 95% CI 0.01 to 1.37, I2 = 0%) but little effect on weight, head circumference, or cognitive development. There was an improvement in anemia (moderate certainty evidence, 2 studies, 381 participants, RR 0.25, 95% CI 0.10 to 0.62, I2 = 0.00%) but no effect on serum ferritin. Limitations include heterogeneity in the included studies. CONCLUSIONS: There are important benefits for human milk-fed preterm and LBW infants from enteral iron supplementation. However, more randomized control trials are required to improve the certainty of evidence.

Normal Weight Obesity: Role of apoB and Insulin Sensitivity in Predicting Future Cardiovascular Risk.

Background: According to NFHS-4 survey, obesity has doubled in India. BMI cannot differentiate body fat from lean mass. Normal weight obesity was defined to distinguish people with normal BMI and increased body fat percentage (BF%). In contrast to conventional atherogenic prediction, Apolipoprotein B level is elevated before LDL cholesterol. Adiposity is also known for causing insulin resistance. Hence this study is an attempt to find the correlation of apo B and Insulin sensitivity in predicting future cardiovascular risk among normal weight obese. To study the role of apoB and insulin resistance in predicting cardio vascular risk. Methods: 269 participants of age group 18-24 in a medical teaching institute were selected for the first phase of the study through systematic random sampling. BF% was calculated with Harpenden skinfold callipers using Jackson Pollock's method. Second phase of the study involved biochemical investigation of 30 NWO participants. ApoB level and insulin sensitivity using HOMA model was estimated. Spearman correlations and simple linear regression were used. Analysis done using SPSSv16. Results: Male and Females were 56.4% and 43.6%, respectively. Out of 269, 44 were found to be having NWO. Hence Prevalence was 16.4%.There is a positive correlation found between apoB and insulin resistance with increasing body fat percentage. Conclusions: Elevated levels of apo B and insulin resistance are seen in NWO individuals as the BF% increases. NWO should be diagnosed early and thus apoB and insulin resistance can be screened for cardio vascular risk prediction.

Body Composition of Infants Born with Intrauterine Growth Restriction: A Systematic Review and Meta-Analysis.

Intrauterine growth restriction (IUGR) may predispose metabolic diseases in later life. Changes in fat-free mass (FFM) and fat mass (FM) may explain this metabolic risk. This review studied the effect of IUGR on body composition in early infancy. Five databases and included studies from all countries published from 2000 until August 2021 were searched. Participants were IUGR or small-for-gestational age (SGA) infants, and the primary outcomes were FFM and FM. Eighteen studies met the inclusion criteria, of which seven were included in the meta-analysis of primary outcomes. Overall, intrauterine growth-restricted and SGA infants were lighter and shorter than normal intrauterine growth and appropriate-for-gestational age infants, respectively, from birth to the latest follow up. They had lower FFM [mean difference −429.19 (p = 0.02)] and FM [mean difference −282.9 (p < 0.001)]. The issue of whether lower FFM and FM as reasons for future metabolic risk in IUGR infants is intriguing which could be explored in further research with longer follow-up. This review, the first of its kind can be useful for developing nutrition targeted interventions for IUGR infants in future.

Utilizing "Positive deviance inquiry" to explore factors influencing child health: A qualitative study.

BACKGROUND: India is a lower middle-income country with one of the fastest growing economies in the world. Despite improvements in its economy, it has a high child mortality rate, with significant differences in child mortality both between and within different states. In this research, we tend to explore factors as to how a particular child's growth is optimal. With this aim, we utilized positive deviance inquiry to study the factors influencing under five child's health. MATERIALS AND METHODS: This qualitative study was carried out in Naigoan, an urban health setting of metropolitan city with 37 sample size between July 2020 and September 2020. It consisted of total 16 in-depth interviews (IDIs), 3 focus group Discussion (FGDs), and 7 key informant interviews (KIIs) which were performed by predesigned guides. RESULTS: Various themes evolved with the interviews; however, triangulation of the concept (from FGDs, IDIs, and KIIs) occurred with the following themes: satisfaction among mothers for health-care services, community participation, family support, and new interventions. CONCLUSION: Mothers' satisfaction to health-care services, community participation, family support, and innovations by the health-care providers are the influencing factors in promoting child's health. Further research can be conducted to understand the in-depth understanding of each factor.

Obesity Prevalence and Determinants among Young Adults, with Special Focus on Normal-Weight Obesity; A Cross-Sectional Study in Mumbai.

BACKGROUND: India has >135 million obese individuals at present. Body mass index (BMI) has been used to assess obesity until recent times. Later, studies have shown that central body fat (BF) measurements as a reliable predictor of metabolic diseases. Hence, normal-weight obesity (NWO) is defined. Those with a normal range of BMI but increased fat percentage are found to be having metabolic syndromes at a very early life. The young adult group is specifically focused on the study with diet and physical activity as potential determinants; as an intervention at the right time can prevent the development of many noncommunicable diseases. OBJECTIVES: The aim of this study is to estimate the prevalence of obesity and its determinants with special reference to NWO. MATERIALS AND METHODS: A cross-sectional study was conducted based on diet, physical activity, and other lifestyle factors on a sample of 269 young adults. Using Harpenden skinfold calipers, BF percentage was calculated based on Jackson and Pollock and Siri's equation. Binary logistic regression was also applied appropriately. RESULTS: The proportion of obesity was 42.01%, and that of NWO was 16.1%. Sex, high protein diet, number of restaurant visits, less homemade tiffin intake, heavy physical activity, alcohol intake were found to be significantly associated with obesity. Intake of fish, physical activity, protein diet, day-time sleep were found to be significantly associated with NWO. CONCLUSION: The study emphasizes the need for including BF percentage in addition to BMI in regular clinical practice. It may help in preventive and promotive efforts.

Magnitude and gender-specific circumstances of depression among elderly population residing in an Urban slum area of a City in Maharashtra: A mixed-method study.

The burden of geriatric mental health in India is showing a silent epidemic trend, but the knowledge on spectrum of their mental well-being dwelling in slums is very trivial. This mixed-method study aimed to estimate the proportion of depression among elderly and to find out the gender-specific circumstances, leading to depression. A total of 209 subjects selected through multistage sampling from an urban slum in a city of Maharashtra were interviewed for estimating depression, and six focus group discussions (FGDs) were conducted to explore the circumstances. Overall, 42.1% of elderly people had depression with 2.8% severe depression. Major themes highlighted after FGDs were self-esteem, social role, dependence, negative experience, and disgrace among males, and among females, main themes were justifiable reason, managing mood, suppression, undesirable events, and stigma. Depression is a significant public health problem, and a diverse approach is required to understand the perception of elderlies which will highlight the core issues related to depression.

Noncompliance of the postexposure prophylactic vaccination following animal bites reporting to a rural primary health center.

CONTEXT: Man lives in close harmony with animals and so the chances of injuries and diseases contracted from them. Effective preventive measure such as vaccination is to be ensured following harmful bites resulting in Rabies. AIM: The aim is to assess the proportion of rabid animal bite cases and non-compliance of post exposure prophylaxis vaccination following bites, reporting to a rural primary health care centre. SETTING AND DESIGN: This is a retrospective cross sectional study from records of animal bite cases attending a rural primary health centre from January 2017 to December 2017. MATERIALS AND METHODS: A pre-designed case record form was used to estimate the proportion of animal bite cases leading to Rabies and Non-compliance of post exposure prophylaxis attending the health centre. STATISTICAL ANALYSIS: Data analysis was done in SPSS 2016. Chi square was used to find the significance. RESULTS: Around 448 animal bites were found over a span of one year, out of which 222 (49.5%) were found to be rabid animal bites. 46.65% (209) were dog bites and 2.9% (13) were cat bites. Statistical significance (P < 0.05) was seen between age and compliance of vaccination following dog bites. 1.14% of the study subjects who had completed the 5 dose post prophylaxis vaccination belonged to the elderly age group. Among the cat bite cases, 2 of the study subjects had received 1 dose of PEP with anti-rabies vaccine. CONCLUSION: Only 1.14% of the study subjects had taken the complete dose of PEP. This suggests the lack of awareness among public and lack of services and supervision for rabid animal bites in rural areas. It is the duty of every physician to counsel people, co-ordinate with veterinary physician and maintain proper records so as to ensure completion of PEP to prevent rabies related deaths in humans.

Mixed-Method Analysis of Community Health Camps: A Novel Approach Beckoning.

BACKGROUND: In India, 60% of the population lack basic medical facilities, so health camps which provide short-term medical interventions for target communities may be beneficial. This study epidemiologically analyzes a health camp event in a rural area of Maharashtra to provide practical insights for organizing, planning, and implementation of health camps. OBJECTIVES: 1. Assess the sociodemographic profile and spectrum of morbidity of camp beneficiaries. 2. Assess expectations and satisfaction perceived by community and organizers from health camps. 3. Gain practical insights from the camp event to advocate participation-friendly policies in the community. MATERIALS AND METHODS: This is a cross-sectional mixed design study. Using qualitative method, a total of four focus group discussions (FGDs) were held with beneficiaries attending the camp and three in-depth interviews (IDIs) were held with camp organizers. A semi-structured questionnaire was used to interview 358 beneficiaries to be studied quantitatively. RESULTS: The camp comprised 52.7% of males and 36.7% of females as beneficiaries. Observed were cases of acute disease (41.6% [n = 149]) and chronic disease (58.7% [n = 209]) with maximum beneficiaries visiting ophthalmology department (25.4%) followed by general medicine (16.70%). FGDs and IDIs revealed two major themes - expectation and satisfaction and several subthemes. CONCLUSION: The beneficiaries appreciated the event and expressed the requirement of organizing such camps in future again. The camp was need based as revealed by the organizers and beneficiaries. Few strategies in future can result in more participation-friendly health camps.

Awareness and acceptance of H1N1 vaccination among physicians: Experience of 2017 vaccination campaign.

CONTEXT: India experienced pandemic phase of H1N1 in May 2009 to December 2010. The postpandemic phase went on from January 2011 to December 2014. As per the WHO, all countries should immunize their health-care workers as a first priority to protect the essential health infrastructure. AIMS: The aim of the study is to assess the level of awareness and acceptance of influenza vaccine among physicians and also the perception of physicians regarding H1N1 infection. This study also examined time of vaccine administration in relation with efficacy concerns based on literature. SETTINGS AND DESIGN: A vaccination campaign was conducted for all health-care workers of Seth GSMC and KEM Hospital, Mumbai, in the month of July 2017 based on which a cross-sectional observational study was conducted among the physicians of the same institute. METHODS: After ethical clearance, a prevalidated pretested survey based on a pilot survey of 20 physicians was distributed among physicians, which was based on the awareness and acceptance of H1N1 vaccination among physicians and perception of H1N1 infection. Effective sample size was 272. STATISTICAL ANALYSIS USED: Descriptive statistics and Chi-square test were generated for the survey responses. All the continuous variables were reported as mean, median, and range. Categorical variables were reported as tables and pie charts. P < 0.05 was taken as significant. Data analysis was done with SPSS version 21. RESULTS: The overall vaccine compliance was 29.8%. This study has found that area of work, deficiency in knowledge about adverse effect of vaccine, misconceptions regarding vaccine, and concerns about efficacy and duration of vaccine are the important factors which lead to decreased vaccine compliance. Furthermore, it is found during the study that timing of vaccination was not given due importance as considering the epidemiological pattern. CONCLUSIONS: More emphasis should be given to education sessions and counseling of physicians regarding H1N1 vaccination and oseltamivir therapy. At administrative level, more focus should be given on timing of vaccination and other logistics. Vaccine campaigns should be conducted ideally 1 month before expected rise in cases. Quadrivalent vaccine would be more appropriate over trivalent based on epidemiology of infection in India.

Strategic implications of changing rule of halves in hypertension: A cross-sectional observational study.

CONTEXT: The burden of non-communicable diseases will sooner overwhelm the health system of the country and could curtail future economic development. Hypertension causes highest cardiovascular morbidities. To attain target Blood Pressure (BP), different strategies are required, which are area specific. The validity of rule of halves of hypertension in various settings needs to be studied for developing strategies for that particular geographical area. To utilize the resources in more efficient way, strategies need to differ in rural-urban and underserved- well-served areas. AIMS: The present study aims at exploring whether the rule of halves holds good in the city of Mumbai as the findings of such research may have implications on strategies to control hypertension in communities. Hence, the objectives of this study are to ascertain the proportion of persons with hypertension with respect to the status of diagnosis, treatment, adequate treatment, and validate it with existing rule of halves. SETTING AND DESIGN: Study was conducted in the urban field practice area of a teaching hospital and medical college of Mumbai that comprises 42 chawl (housing structures); study design- cross-sectional observational study. MATERIALS AND METHODS: This observational cross-sectional study was conducted over a period of 18 months in the field practice area of a teaching hospital and medical college of Mumbai with a total population of 43,069. Sample size was 667. After ethical clearance, participants were interviewed using pretested semi-structured interview schedule that included socio-demographic factors, risk factor evaluation, clinical examination, and anthropometry. Subjects with diagnosed hypertension were questioned thoroughly about hypertension adherence. STATISTICAL ANALYSIS: Descriptive statistics was applied on quantitative data. RESULTS: A total of 667 people from five chawls of age more than 35 years were included into the study. The mean age of study subjects was 50.84 ± 11.47 years. Out of total 667 respondents, 20.3% respondents were normotensive, 50.3% respondents were pre-hypertensive, 25.3% respondents were in stage 1 hypertension, and 4% respondents were in stage 2 hypertension. In contrary to the classical rule of halves, the present study shows only 31% of the diagnosed hypertensives are adequately treated. CONCLUSIONS: The strategies in the national programs are from the traditional understanding of rule of halves and emphasize increasing awareness and treatment. Family physician should actively involve in regular screening, treatment, and adherence of hypertension treatment. As a part of primary care, community participation is required for effectively achieving the target BP goal of the population.