Sociocultural environmental factors and childhood stunting: qualitative studies - a protocol for the Shared Values theme of the UKRI GCRF Action Against Stunting Hub.

INTRODUCTION: Stunting is a significant and growing global problem that is resisting scientific attempts to understand it in terms of direct nutrition-related determinants. In recent years, research included more complex, indirect and multifactorial determinants and expanded to include multisectoral and lifestyle-related approaches. The United Kingdom Research Initiative Global Challenges Research Fund's (UKRI GCRF) Action Against Stunting Hub starts on the premise that dominant factors of stunting may vary between contexts and life phases of the child. Thus, the construction of a typology of clustered factors will be more useful to design effective programmes to alleviate it.The Shared Values theme seeks to build a bottom-up holistic picture of interlinked cultural contextual factors that might contribute to child stunting locally, by first eliciting shared values of the groups closest to the problem and then enquiring about details of their relevant daily activities and practices, to reveal links between the two. We define shared values as what groups consider 'valuable, worthwhile and meaningful' to them. METHODS AND ANALYSIS: We will recruit 12-25 local stakeholder groups in each site (in India, Indonesia and Senegal) involved in children's food and early learning environments, such as mothers, fathers, grandmothers, teachers, market vendors and health workers. The WeValue InSitu process will be used to assist them to collectively elicit, negotiate and self-articulate their own shared values through exploration of shared tacit knowledge. Focus group discussions held immediately subsequently will ask about daily activities relevant to the children's environment. These contain many examples of cultural contextual factors potentially influencing stunting locally, and intrinsically linked to shared values articulated in the previous session.

Eggs for Improving Nutrition, cognitive development and reducing linear growth retardation among Infants and young Children (ENRICH): protocol of an egg supplementation trial among children aged 9-18 months in Hyderabad, India.

INTRODUCTION: Evidence on the impact of nutrient-rich animal source foods such as eggs for improving child growth and cognition is inconsistent. This study aims to examine the impact of an egg intervention in children, along with behaviour change communication (BCC) to the mother, on linear growth and cognition, and nutritional status in children aged 9-18 months. METHODS AND ANALYSIS: A 9-month open-labelled randomised controlled trial will be conducted in three urban slums in Hyderabad, India, as a substudy of an observational cohort study (n=350) following pregnant women and their children until 18 months of age in a population at risk of stunting. The children born to women enrolled during the third trimester of pregnancy will be block randomised in a 1:4 ratio into the intervention (n=70) and control (n=280) groups. Children in the intervention group will be supplemented with one egg per day starting from 9 months until 18 months of age. BCC designed to enhance adherence to the intervention will be used. The control group will be a part of the observational cohort and will not receive any intervention from the study team. The primary outcome will be length-for-age z-scores, and the secondary outcomes will include cognition, blood biomarkers of nutritional status including fatty acid profile and epigenetic signatures linked with linear growth and cognition. Multivariate intention-to-treat analyses will be conducted to assess the effect of the intervention. ETHICS AND DISSEMINATION: The study is approved by the Institutional ethics committees of ICMR-National Institute of Nutrition, Hyderabad, India and London School of Hygiene and Tropical Medicine, UK. The results will be published in peer-reviewed journals and disseminated to policy-makers. Findings will also be shared with study participants and community leaders. TRIAL REGISTRATION NUMBER: CTRI/2021/11/038208.

A Randomized Multiple Micronutrient Powder Point-of-Use Fortification Trial Implemented in Indian Preschools Increases Expressive Language and Reduces Anemia and Iron Deficiency.

BACKGROUND: Anemia is a global public health problem that undermines childhood development. India provides government-sponsored integrated nutrition/child development preschools. OBJECTIVES: This double-masked, cluster-randomized controlled trial examines whether point-of-use multiple micronutrient powder (MNP) compared with placebo fortification of preschool meals impacts child development and whether effects vary by preschool quality (primary outcome) and biomarkers of anemia and micronutrients (secondary outcomes). We also measured growth and morbidity. METHODS: We randomly assigned 22 preschools in rural India to receive MNP/placebo fortification. We administered baseline and endline blood sampling and measures of childhood development (Mullen Scales of Early Learning, inhibitory control, social-emotional), anthropometry, and morbidity to preschoolers (aged 29-49 mo). Preschools added MNP/placebo to meals 6 d/wk for 8 mo. We conducted linear mixed-effects regression models accounting for preschool clustering and repeated measures. We evaluated child development, examining effects in high- compared with low-quality preschools using the Early Childhood Environment Rating Scale-Revised and the Home Observation for the Measurement of the Environment Inventory, modified for preschools. RESULTS: At baseline, mean age ± SD was 36.6 ± 5.7 mo, with 47.8% anemic, 41.9% stunted, and 20.0% wasted. Baseline expressive/receptive language scores were higher in high-quality compared with low-quality preschools (P = 0.02 and P = 0.03, respectively). At endline (91% retention, n = 293/321), we found MNP compared with placebo effects in expressive language (Cohen's standardized effect d = 0.4), inhibitory control (d = 0.2), and social-emotional (d = 0.3) in low-quality, not high-quality, preschools. MNP had significantly greater reduction of anemia and iron deficiency compared with placebo (37% compared with 13.5% and 41% compared with 1.2%, respectively). There were no effects on growth or morbidity. CONCLUSIONS: Providing multiple micronutrient-fortified meals in government-sponsored preschools is feasible; reduced anemia and iron deficiency; and, in low-quality preschools, increased preschoolers' expressive language and inhibitory control and reduced developmental disparities. Improving overall preschool quality by incorporating multiple components of nurturing care (responsive care, learning, and nutrition) may be necessary to enhance preschoolers' development. This trial was registered at clinicaltrials.gov as NCT01660958.

Guava with an institutional supplementary meal improves iron status of preschoolers: a cluster-randomized controlled trial.

The Integrated Child Development Services of India provides Supplementary Nutrition Program (SNP) to preschoolers. Using this platform, the current study examined the impact of diversifying a cereal/pulse-based SNP-meal with guava on iron status and cognitive development among 24-48 months old children. A three-arm, nonblinded, cluster-randomized controlled trial (CTRI/2014/09/004983) included 399 beneficiaries from 28 preschools in 16 villages in Telangana state, India. The villages were randomly assigned to receive 25 g of guava (guava group (GG)), banana (banana group (BG)), or cucumber (cucumber group (CG)) along with a SNP meal for 140 days. Nutrient biomarkers (iron status, plasma vitamin C, vitamin B12 , and folate), cognitive development, anthropometric indicators (WAZ, HAZ, and WHZ), and morbidity were assessed at baseline and endline. A linear mixed model and a generalized estimating equation were applied to compare changes in outcomes across the groups. All outcome variables were comparable across groups at baseline. The iron to vitamin C molar ratio improved in the GG from 1:1.4 to 1:12 but remained unaltered in control groups. Higher hemoglobin (P = 0.002), serum ferritin (SF; P < 0.001), vitamin C (P = 0.047), and lower soluble transferrin receptor (sTfR; P < 0.001) causing decreased prevalence of iron deficiency (ID) (P = 0.003) were observed in the GG compared with BG and CG. Prevalence of acute respiratory infection (ARI) was lower in the GG (P = 0.035) versus controls. No impact was observed on cognitive development or growth. Thus, diversifying a cereal/pulse-based meal with guava increased meal vitamin C content, thereby reducing ID and ARI-related morbidity. This approach represents a valid and scalable strategy to address ID among young children.

A food synergy approach in a national program to improve the micronutrient status of preschoolers: a randomized control trial protocol.

Iron deficiency anemia (IDA) is a significant public health issue in India affecting nearly all vulnerable segments of the population. Causes of IDA include low consumption of iron-rich foods combined with poor iron bioavailability of nonheme iron sources. To date, interventions aimed at correcting IDA focus on increasing iron intake through iron supplementation or fortification strategies. In contrast, dietary diversification is a long-term sustainable approach to improve bioavailable iron intake. In this context, the inclusion of vitamin C-rich fruits in the regular diet has proven to improve iron absorption, but the effect on iron status is inconclusive. Considering the ongoing national program for preschoolers in India, we designed a cluster randomized controlled trial (RCT) to test the hypothesis that inclusion of vitamin C-rich fruit in a regular meal would improve iron absorption and lead to better child iron and micronutrient status, cognitive development, gut health, and growth while reducing morbidity. This paper illustrates a context-specific framework and activities to design and functionalize an open-label, three-arm cluster RCT to test a specific hypothesis. The results of this designed trial should generate evidence to inform policy on the effect of a food-based intervention on iron status.

Formative research methods for designing culturally appropriate, integrated child nutrition and development interventions: an overview.

Nutritional and developmental insults in the first few years of life have profound public health implications, including substantial contributions to neonatal, infant, and early childhood morbidity and mortality, as well as longer term effects on cognitive development, school achievement, and worker productivity. Optimal development that can lead to the attainment of an individual's fullest potential, therefore, requires a combination of genetic capacity, adequate nutrition, psychosocial stimulation, and safe, clean physical environments. Researchers and policymakers have called for integrated child nutrition and development interventions for more than 20 years, yet there are only a handful of efficacy trials and even fewer examples of integrated interventions that have been taken to scale. While a critical component in the design of such interventions is formative research, there is a dearth of information in both the literature and policy arenas to guide this phase of the process. To move the field forward, this paper first provides an overview of formative research methods with a focus on qualitative inquiry, a description of the critical domains to be assessed (infant and young child feeding, responsive feeding, and child development), and currently available resources. Application of these methods is provided through a real-world case study--the design of an integrated nutrition and child development efficacy trial in Andhra Pradesh, India. Recommendations for next steps are discussed, the most important of which is the need for a comprehensive set of formative guidelines for designing locally tailored, culturally appropriate, integrated interventions.

Integrating nutrition and early child-development interventions among infants and preschoolers in rural India.

This article describes the development, design, and implementation of an integrated randomized double-masked placebo-controlled trial (Project Grow Smart) that examines how home/preschool fortification with multiple micronutrient powder (MNP) combined with an early child-development intervention affects child development, growth, and micronutrient status among infants and preschoolers in rural India. The 1-year trial has an infant phase (enrollment age: 6-12 months) and a preschool phase (enrollment age: 36-48 months). Infants are individually randomized into one of four groups: placebo, placebo plus early learning, MNP alone, and MNP plus early learning (integrated intervention), conducted through home visits. The preschool phase is a cluster-randomized trial conducted in Anganwadi centers (AWCs), government-run preschools sponsored by the Integrated Child Development System of India. AWCs are randomized into MNP or placebo, with the MNP or placebo mixed into the children's food. The evaluation examines whether the effects of the MNP intervention vary by the quality of the early learning opportunities and communication within the AWCs. Study outcomes include child development, growth, and micronutrient status. Lessons learned during the development, design, and implementation of the integrated trial can be used to guide large-scale policy and programs designed to promote the developmental, educational, and economic potential of children in developing countries.

Cluster-randomized trial on complementary and responsive feeding education to caregivers found improved dietary intake, growth and development among rural Indian toddlers.

Inadequate feeding and care may contribute to high rates of stunting and underweight among children in rural families in India. This cluster-randomized trial tested the hypothesis that teaching caregivers appropriate complementary feeding and strategies for how to feed and play responsively through home-visits would increase children's dietary intake, growth and development compared with home-visit-complementary feeding education alone or routine care. Sixty villages in Andhra Pradesh were randomized into three groups of 20 villages with 200 mother-infant dyads in each group. The control group (CG) received routine Integrated Child Development Services (ICDS); the complementary feeding group (CFG) received the ICDS plus the World Health Organization recommendations on breastfeeding and complementary foods; and the responsive complementary feeding and play group (RCF&PG) received the same intervention as the CFG plus skills for responsive feeding and psychosocial stimulation. Both intervention groups received bi-weekly visits by trained village women. The groups did not differ at 3 months on socioeconomic status, maternal and child nutritional indices, and maternal depression. After controlling for potential confounding factors using the mixed models approach, the 12-month intervention to the CFG and RCF&PG significantly (P < 0.05) increased median intakes of energy, protein, Vitamin A, calcium (CFG), iron and zinc, reduced stunting [0.19, confidence interval (CI): 0.0-0.4] in the CFG (but not RCF&PG) and increased (P < 0.01) Bayley Mental Development scores (mean = 3.1, CI: 0.8-5.3) in the RCF&PG (but not CFG) compared with CG. Community-based educational interventions can improve dietary intake, length (CFG) and mental development (RCF&PG) for children under 2 years in food-secure rural Indian families.