Health and Nutrition

Our research confirmed the safety of the intervention but showed no sustained benefits in terms of vitamin A status beyond 6 months or infant morbidity (Lancet 1998;352:1257-63). The study promptly halted a global decision by the UNICEF to extend the vitamin A program to under 6 months old children rather than keep it restricted to children older than 9 months, therefore, having a major influence on policy.

Designed and implemented the largest study of zinc supplementation in children of low income communities to examine its impact on pneumonia and diarrhea. The study established that optimal zinc intake can prevent up to 26% of pneumonia in young children (Br Med J 2002; 324:1358-1362) and reduce the incidence of diarrhea by 12%, severe diarrhea by 24% and recurrent diarrhea by 49% (Pediatrics 2002;109 (6):86-92). This triggered global interest in zinc deficiency as a problem, similar in magnitude to iron and vitamin A deficiency.

Demonstrated favourable impact of exclusive breast feeding for 6 months on severe morbidity and growth. This had an impact on the nationwide programmes for exclusive breastfeeding up to 6 months (Lancet 2003;361:1418-1423).

Educational interventions using multiple sources lead to improvement in feeding behaviour and linear growth (J Nutr 2004;134:2342-2348, Bull World Health Organ 2005;83:418-426)

Established effectiveness of zinc and low osmolarity ORS in the community for treatment of diarrhea and as a disease prevention measure. This study resulted in policy impact in India and developing countries (J Pediatr Gastroenterol Nutr 2005; 41:685-687, Pediatrics 2008; 121:e1279-85, Bull World Health Organ 2010; 88:717-796

Demonstrated zinc deficiency as a public health problem and that zinc supplementation reduces the incidence and severity of enteric and respiratory infections (Acta Paediatr 1996;85:148-50, Am J Clin Nutr 1998; 68:414S-7S), mortality (J Nutr 2007; 137:112-117), linear growth (J Nutr 2010;140:630-634) and low birth weight infants (Am J Clin Nutr 2009;90:385-91). Paved way for global and national efforts to combat zinc deficiency.

We demonstrated lack of substantial benefit of large dose neonatal vitamin A supplementation in neonates given at birth in reduction of infant mortality in a population in which vitamin A deficiency is a moderate public health outcome. Evidence contributed to halting efforts to encourage neonatal vitamin A supplementation in Asian settings (Trials 2012;13:22 Lancet 2014; pii: S0140-6736(14)60891-6).

The first randomised trial comparing RUTF with energy and nutrient-dense home-prepared foods (the comparison group) confirms the efficacy of RUTF in the treatment of children with uncomplicated SAM. The study provided insights on the importance of feeding efforts and the caregiver support required for higher efficacy and highlights the importance of adequate continued inputs after initial treatment to sustain the benefits. Recommendations for policy: Children with uncomplicated SAM can be managed at home with RUTF instead of through inpatient hospitalisation (BMJ Global Health 2016; DOI:10.1136/bmjgh-2016-000144).

In a secondary analysis of data from the trial, we assessed the performance of Mid Upper Arm Circumference (MUAC) as a predictor of mortality in children aged 6–59 months, one year after their initial MUAC measurements were taken. The finding revealed that MUAC is a significant predictor of subsequent mortality in under-five children. MUAC can be used as a screening tool for identifying severely malnourished children for management in settings where height measurement is not feasible (PLoS One. 2018;13(6):e0197832).

Conducted formative research to assess the feasibility, acceptability and adoption of community-initiated KMC with the aim of designing an intervention package for a randomised controlled trial in LBW infants in Haryana, India, which demonstrated that community-initiated KMC is acceptable by mothers and adoption rates are high (BMC Public Health 2018;18:307)

Conducted the first and the largest community-initiated randomized controlled trial demonstrating irrefutable evidence of the benefits of community initiated KMC on reducing neonatal mortality, pneumonia, diarrhea and severe acute malnutrition, and increased exclusive breastfeeding in low birth weight infants (Trials 2017;18:262; Lancet. 2019;394:1724-1736).

We conducted an implementation research in Sangrah, a remote hilly block of Himachal Pradesh, to encourage the health functionaries to use the simplified treatment regimen, with the aim to achieve 80% identification and treatment of infants aged 0-59 days with PSBI, and documentation of key barriers and facilitators that influence the use of the simplified treatment regimen. About 80% (160) of the expected PSBI cases were identified, of them 48 (30%) sick infants accepted referral to a tertiary care hospital and 112 (70%) were treated according to the simplified treatment regimen at SC, PHC and CHC. Treatment failure rate was 8% in the group receiving simplified treatment regimen and 10% in those treated in a tertiary care hospital, which is comparable. There were 2 deaths (CFR 1.2%) in the former group and 4 (CFR 8.3%) in the latter. Timely identification of signs of illness by families and health system weaknesses such as non-availability of essential commodities, medicines and human resource gaps were challenges in implementation of the guideline. Implementation of the guidelines in program settings is possible and acceptable. Scaling up would require creating community awareness, early identification and appropriate care seeking, strengthening ASHA home visitation program, building skills and confidence of MOs and ANMs, uninterrupted supplies and a dependable referral system (PLoS One 2020;15:e0243724) .

In lower-middle income settings, growth faltering in the first 6 months of life occurs despite exclusive breastfeeding.  We tested the efficacy of an approach to improve the dietary adequacy of mothers during lactation and thus improve the growth of their infants. Eligible mother–infant dyads (infants ≤7 days of age) were randomized to either intervention or control groups. Mothers in the intervention group received snacks that were to be consumed daily, which provided 600 kcal of energy—with 25–30% of energy derived from fats (150-180 kcal) and 13% of energy from protein (80 kcal). Micronutrients were supplemented as daily tablets. We provided counseling on breastfeeding and infant-care practices to mothers in both groups. The primary outcome was attained infant length-for-age z-scores (LAZ) at 6 months of age. Secondary outcomes included exclusive breastfeeding proportion reported by the mother, maternal body mass index (BMI) and mid-upper arm circumference (MUAC), hemoglobin concentrations in mothers and infants, and the proportion of anemic infants at 6 months of age. Postnatal supplementation of 600 kcal energy, 20 g protein, and multiple micronutrients daily to lactating mothers did not affect infant LAZ at age 6 months. Trial Registration CTRI/2018/04/013095

Adverse birth outcomes such as prematurity, intrauterine growth retardation, stunting and cognitive impairment in young children are driven by risk factors in women of reproductive age prior to and during pregnancy.

The study aims to assess the impact of a package of health, nutrition, psychosocial care and environmental interventions delivered in pre pregnancy, pregnancy and first 2 years of the child’s life on birth weight and length, prematurity, fetal growth restriction and stunting at 2 years age (Trials. 2020;21(1):127).

This study will help in understanding the extent to which linear growth can be accelerated when all evidence-based interventions are delivered with high compliance. It will indicate the importance of providing interventions during the pre- and peri-conception periods for reducing prematurity and stunting. It will also address whether maternal height is an effect modifier in the intervention impact. Status: Study ongoing (Trial Registration CTRI/2017/06/008908)

There are very limited data on RTI/STIs in India. There is uncertainty regarding the etiologic magnitude of the RTI/STI problem. Apart from few prevalence surveys among key populations, there are no population-based RTI/STI data.

This is an observational study to determine the prevalence of laboratory confirmed RTI/STIs (Neisseria gonorrhoeae (NG), Chlamydia trachomatis (CT), Trichomonas vaginalis (TV), Candida albicans and bacterial vaginosis among symptomatic and asymptomatic women of reproductive age group

Evidence generated through this study will provide important information for the national RTI/STI case management guidelines. Status: Study Ongoing (Trial Registration: CTRI/2020/03/023954).

Limited research is available on how women cope with infertility and the actions taken. Also, understanding household out-of-pocket expenditure in the quest to conceive is important in formulating the kind of subsidies that can be provided in the context of fertility care services.

This is an observational study to describe women’s actions and experiences related to failure to conceive, their quality of life and mental health (anxiety and depression) and costs related to interventions to enhance fertility.

The findings will provide essential information for developing additional supportive environment, policies and services for infertile couples in India. Status: Study ongoing  (Trial Registration: CTRI/2020/03/023955)

A randomized controlled trial will be done to address the question on whether OPD based treatment of young infants with low mortality risk clinical severe infection signs, results in better outcome compared to hospital based treatment.

Due to the COVID pandemic, situations have changed with possible impact on the management of PSBI at the study sites.

The formative research, prior to study initiation aims to identify the barriers and facilitators for PSBI management in young infants throughout the entire pathway from identification to care seeking, receiving treatment and follow up care and formulate acceptable solutions in collaboration with the local government health care providers and caregivers of young infants. The solutions will aim to promote optimal management of sick young infants without jeopardizing with their safety. Status: Completed (Trial Registration CTRI/2020/11/029377).

This implementation research aims to achieve high population based coverage of pneumonia treatment for under five children, as recommended in the government of India Guidelines.

Based on the positive previous experiences of using implementation research in scaling up KMC across the state, the trials on operationalizing. Integrated Community Case Management (ICCM) of childhood illnesses by CHWs and the cluster randomized controlled trial to ascertain effectiveness of enhanced community case management to increase access to pneumonia treatment (EMPIC), the government is keen to implement this program to scale up pneumonia treatment. EMPIC interventions include treatment of fast breathing pneumonia in 7-59 days old infants and chest indrawing pneumonia in 2-59 months old children with oral amoxicillin. Treatment will be provided through OPDs, at all government health facilities including HWC, PHC, CHC, DH as well as private OPDs in formal and informal sectors.

OPD based treatment will be provided by trained health staff at the health facilities – Medical Officers, Community Health Officers (CHO), ANMs, MPW.

Status: to be initiated after approvals.

Anemia is a major unresolved public health problem in India, despite a national control programme and routine supplementation with IFA. It has serious consequences on physical and mental development in children. The optimal gain in haemoglobin levels and consequently anaemia reduction through iron supplementation may not be achieved in the background of micronutrient deficiency.

This study aims to compare the efficacy of biweekly supplementation of erythropoiesis-relevant multiple micronutrients plus iron folic acid, with daily iron folic acid alone on haemoglobin concentration and proportion anaemic.

The findings will generate critical information for the current anemia control policy in India and low- and middle-income countries. Status: Study ongoing (CTRI/2020/10/028298).

Incident stunting and wasting are now identified to be of concern even in the first 6 months of life when exclusive breastfeeding is recommended. Preliminary data from an ongoing intervention study in Delhi within which the current research will be embedded shows that 30-35% of babies experience inadequate weight gain and 20-25% inadequate length gain between 4-6 months of age. Conceptually, this could be related to infant size and gestation at birth, infant enteric or other infections, systemic inflammation, gut microbiome structure, IGF-1, or breast milk composition. The primary research question is to assess an integrated intervention package delivered in 1000 days plus period on breast milk quality, systemic inflammation markers, gut microbiome, and IGF-1 at 6 months of age compared to routine care. In addition, whether the effect of integrated intervention package on growth failure during 4-6 months of age mediates through these biomarkers, will also be assessed. The study will be embedded in an ongoing individual randomized controlled study with factorial design (WINGS) (CTRI/2017/06/008908). 400 mother-infant pairs will be selected (by an independent statistician from WHO) at birth for the study. Biological samples will be collected at 3 and 6 months of life from mother-infant pairs. Status: Study ongoing (Trial Registration CTRI/2020/10/028770)