Integrating early child development into an existing health and nutrition program: evidence from a cluster-randomized controlled trial.

INTRODUCTION: In low-resource settings, introducing child health programs into community services may compete for caregiver time. We analyzed the impact of a new early childhood development (ECD) program in rural Madagascar on family attendance at other health services and of adding at-home play materials on program attendance. METHODS: We randomized 75 communities where community health workers (CHWs) implement an existing child health and nutrition program (Projet d'Amélioration des Résultats Nutritionnels or PARN), the status quo. We offered two 6-month cycles of 12 ECD sessions to eligible caregiver-child dyads (6-30 months) in 25 sites [T]; we added take-home play materials in Cycle 2 to 25 sites [T+]. We used differences-in-differences with administrative data to analyze the effect of offering ECD sessions on monthly PARN attendance (T+/T vs. C) among age-eligible children and the impact of toy boxes/libraries on monthly ECD session attendance (T + vs. T). We used random intercept models to analyze characteristics associated with program registration. RESULTS: We analyzed data for 9,408 dyads; 30% and 32% registered for the program in Cycle 1 and 2 (respectively). On average, CHWs delivered 11.4 sessions (SD: 1.5). Children from wealthier households who already attended PARN sessions were more likely to register, and we found no effect of T or T + on PARN attendance. Adding play materials did not affect monthly ECD session attendance. Children from more populated sites were less likely to participate in both ECD and PARN sessions. CONCLUSIONS: Integrating new services for ECD into the health system was feasible and did not reduce dyad participation in existing services. Investment in health services in more populated areas is needed to provide coverage to all eligible children. Novel strategies should be explored to engage the most vulnerable children in new and existing health services. TRIAL REGISTRATION: AEA Social Science Registry (AEARCTR-0004704) on November 15, 2019 (prospective registration) and ClinicalTrials.gov (NCT05129696) on November 22, 2021 (retrospective registration).

Psychometrics of psychosocial behavior items under age 6 years: Evidence from Nebraska, USA.

Because healthy psychosocial development in the first years of life is critical to lifelong well-being, governmental, and nongovernmental organizations are increasingly interested in monitoring psychosocial behaviors among populations of children. In response, the World Health Organization is developing the Global Scales of Early Development Psychosocial Form (GSED PF) to facilitate population-level psychosocial monitoring. Once validated, the GSED PF will be an open-access, caregiver-reported measure of children's psychosocial behaviors that is appropriate for infants and young children. This study examines the psychometric validity evidence from 45 items under consideration for inclusion in the GSED PF. Using data from N = 836 Nebraskan (USA) children aged 180 days to 71 months, results indicate that scores from 44 of the 45 (98%) items exhibit positive evidence of validity and reliability. A bifactor model with one general factor and five specific factors best fit the data, exhibited strong reliability, and acceptable model fit. Criterion associations with known predictors of children's psychosocial behaviors were in the expected direction. These findings suggest that measurement of children's psychosocial behaviors may be feasible, at least in the United States. Data from more culturally and linguistically diverse settings is needed to assess these items for global monitoring.

Debido a que el desarrollo sicosocial en los primeros años de vida es crítico para el bienestar de toda la vida, las organizaciones gubernamentales y no gubernamentales están más y más interesadas en observar vigilantemente las conductas sicosociales en la población infantil. Como respuesta, la Organización Mundial de la Salud está desarrollando el Formulario Sicosocial de las Escalas Globales del Temprano Desarrollo (GSED PF) para facilitar la observación sicosocial alerta al nivel del grupo de población. Una vez que se haya convalidado, el GSED PF será una medida de acceso abierto, que reportará el cuidador, sobre las conductas sicosociales de los niños que son apropiadas para infantes y niños pequeñitos. Este estudio examina la evidencia de la validez sicométrica de 45 puntos bajo consideración para ser incluidos en el GSED PF. Usando datos de N = 836 niños de Nebraska (Estados Unidos), de edad entre 180 días y 71 meses, los resultados indican que los puntajes de 44 de los 45 (98%) puntos muestran evidencia positiva de validez y confiabilidad. Un modelo bifactorial con un factor general y cinco factores específicos, que mejor encaja con los datos, mostró una fuerte confiabilidad y un modelo aceptable que encaja. Las asociaciones de criterio con factores de predicción conocidos acerca de las conductas sicosociales de los niños se encontraban en la dirección esperada. Estos resultados sugieren que la medida de las conductas sicosociales de los niños pudiera ser posible, por lo menos en los Estados Unidos. Se necesitan datos de escenarios más diversos cultural y lingüísticamente para evaluar estos puntos para la estar alerta en la observación global.

Maternal obesity and childhood asthma risk: Exploring mediating pathways.

BACKGROUND: Growing evidence for the effect of maternal obesity on childhood asthma motivates investigation of mediating pathways. OBJECTIVE: To investigate if childhood body mass index (BMI), gestational weight gain (GWG) and preterm birth mediate the association of maternal obesity on childhood asthma risk. METHODS: We used electronic medical records from mother-child pairs enrolled in Kaiser Permanente Northern California integrated healthcare system. Children were followed from their birth (2005-2014) until at least age 4 (n = 95,723), age 6 (n = 59,230) or age 8 (n = 25,261). Childhood asthma diagnosis at each age was determined using ICD-9/10 codes and medication dispensings. Prepregnancy BMI (underweight [<18.5], normal [18.5-24.9], overweight [25-29.9], obese [≥30] kg/m2 ) were defined using height and weight measurements close to the last menstrual period date. Child's BMI (Centers for Disease Control and Prevention BMI-for-age percentiles: underweight [<5th], normal [5th-85th], overweight [85th-95th], obese [>95th]) were obtained using anthropometric measurements taken the year preceding each follow-up age. GWG (delivery weight-prepregnancy weight) was categorised based on Institutes of Medicine recommendations (inadequate, adequate, excessive). Implementing first causal inference test (CIT) then causal mediator models (to decompose the natural direct and indirect effects), we examined the potential mediating effect of childhood BMI, GWG, and preterm birth on the association between prepregnancy BMI (continuous and categorical) and childhood asthma. RESULTS: Overall, risk of childhood asthma increased as prepregnancy BMI increased (age 4 risk ratio: 1.07, 95% confidence interval: 1.04, 1.09, per 5 kg/m2 increase in BMI; similar for age 6 and 8). CIT identified childhood BMI and preterm birth, but not GWG as potential mediators. Causal mediation models confirmed childhood BMI, but not preterm birth, as having a partial mediating effect. Results were similar for age 6 and 8, and when continuous mediators (instead of binary) were assessed. CONCLUSIONS: Childhood overweight/obesity has a modest mediating effect on the association between prepregnancy BMI and childhood asthma.

Integrating early stimulation and play at scale: study protocol for "MAHAY Mikolo", a multi-arm cluster-randomized controlled trial.

BACKGROUND: Hundreds of millions of children living in poverty worldwide are not reaching their full, developmental potential. Programs to promote nurturing and responsive caregiving, such as those in which community health workers (CHWs) conduct home visits to support optimal early childhood development (ECD), have been effective in small trials, but have not achieved similar success at scale. This study will explore two approaches to scale-up: converting a home-visiting model to a group-based model; and integrating the ECD curriculum into an existing government program. The objectives of the study are to: 1) Measure how the integration of ECD activities affects time and task allocation of CHWs and CHW psychosocial wellbeing; 2) Examine how the integration of ECD activities affects caregiver-child dyad participation in standard health and nutrition activities; and 3) Explore how the availability of age-appropriate play materials at home affects caregiver-child dyad participation rates in a group-based ECD program. METHODS: We will randomize 75 communities in rural Madagascar into three arms: 1) [C], which is the status quo (community-based health and nutrition program); 2) [T], which is C + ECD group sessions [T]; and 3) [T +], which is T with the addition of an enhanced play materials package for home use. All children between 6-30 months old at the time of the intervention launch will be eligible to participate in group activities. The intervention will last 12 months and is comprised of fortnightly group sessions in which the CHWs provide caregiver-child dyads with information relating to ECD; CHWs will also include structured time for caregivers to practice the play and child stimulation activities they have learned. We will administer monthly surveys to measure CHW time use and task allocation, and we will leverage administrative data to measure caregiver-child dyad participation in the group sessions. DISCUSSION: The results from the trial will provide the evidence base required to implement an integrated package of nutrition, health and ECD promotion activities at scale in Madagascar, and findings may be relevant in other low-income countries. TRIAL REGISTRATION: This trial is registered on the AEA Social Science Registry (AEARCTR-0004704) on November 15, 2019 and on ClinicalTrials.gov (NCT05129696) on November 22, 2021.

Levels and potential drivers of under-five mortality sex ratios in low- and middle-income countries.

BACKGROUND: Non-biological childhood mortality sex ratios may reflect community sex preferences and gender discrimination in health care. OBJECTIVE: We assessed the association between contextual factors and gender bias in under-five mortality rates (U5MR) in low- and middle-income countries. METHODS: Full birth histories available from Demographic and Health Surveys and Multiple Indicator Cluster Surveys (2010-2018) in 80 countries were used to estimate U5MR male-to-female sex ratios. Expected sex ratios and their residuals (difference of observed and expected) were derived from a linear regression model, adjusted for overall mortality. Negative residuals indicate more likelihood of discrimination against girls, and we refer to this as a measure of potential gender bias. Associations between residuals and national development and gender inequality indices and with survey-derived child health care indicators were tested using Spearman's correlation. RESULTS: Mortality residuals for under-five mortality were not associated with national development, education, religion, or gender inequality indices. Negative residuals were more common in countries where boys were more likely to be taken to health services than girls (rho -0.24, 95% confidence interval -0.45, -0.01). CONCLUSIONS: Countries where girls were more likely to die than boys, accounting for overall mortality levels, were also countries where boys were more likely to receive health care than girls. Further research is needed to understand which national characteristics explain the presence of gender bias, given that the analyses of development levels and gender equality did not discriminate between countries with or without excess mortality of girls. Reporting on child mortality separately by sex is required to enable such advances.

Gender equality and gender norms: framing the opportunities for health.

The Sustainable Development Goals offer the global health community a strategic opportunity to promote human rights, advance gender equality, and achieve health for all. The inability of the health sector to accelerate progress on a range of health outcomes brings into sharp focus the substantial impact of gender inequalities and restrictive gender norms on health risks and behaviours. In this paper, the fifth in a Series on gender equality, norms, and health, we draw on evidence to dispel three myths on gender and health and describe persistent barriers to progress. We propose an agenda for action to reduce gender inequality and shift gender norms for improved health outcomes, calling on leaders in national governments, global health institutions, civil society organisations, academic settings, and the corporate sector to focus on health outcomes and engage actors across sectors to achieve them; reform the workplace and workforce to be more gender-equitable; fill gaps in data and eliminate gender bias in research; fund civil-society actors and social movements; and strengthen accountability mechanisms.

Gender norms and health: insights from global survey data.

Despite global commitments to achieving gender equality and improving health and wellbeing for all, quantitative data and methods to precisely estimate the effect of gender norms on health inequities are underdeveloped. Nonetheless, existing global, national, and subnational data provide some key opportunities for testing associations between gender norms and health. Using innovative approaches to analysing proxies for gender norms, we generated evidence that gender norms impact the health of women and men across life stages, health sectors, and world regions. Six case studies showed that: (1) gender norms are complex and can intersect with other social factors to impact health over the life course; (2) early gender-normative influences by parents and peers can have multiple and differing health consequences for girls and boys; (3) non-conformity with, and transgression of, gender norms can be harmful to health, particularly when they trigger negative sanctions; and (4) the impact of gender norms on health can be context-specific, demanding care when designing effective gender-transformative health policies and programmes. Limitations of survey-based data are described that resulted in missed opportunities for investigating certain populations and domains. Recommendations for optimising and advancing research on the health impacts of gender norms are made.

Lipid-Based Nutrient Supplementation Reduces Child Anemia and Increases Micronutrient Status in Madagascar: A Multiarm Cluster-Randomized Controlled Trial.

BACKGROUND: Iron deficiency anemia affects hundreds of millions of women and children worldwide and is associated with impaired infant outcomes. Small-quantity lipid-based nutrient supplement (LNS) have been found to reduce the prevalence of anemia and iron deficiency in some trials. OBJECTIVES: We evaluated the effectiveness of daily LNS supplementation on child anemia and micronutrient status in Madagascar within the context of an existing, scaled-up nutrition program. METHODS: We cluster-randomized 125 communities to (T0) a routine program with monthly growth monitoring and nutrition education; (T1) T0 + home visits for intensive nutrition counselling; (T2) T1 + LNS for children aged 6-18 mo; (T3) T2 + LNS for pregnant/lactating women; or (T4) T1 + parenting messages. Pregnant women and infants aged <12 mo were enrolled in 2014 and followed for 2 y. Child outcome measures included hemoglobin and anemia assessed using the HemoCue 301 system (n = 3561), and serum ferritin and soluble transferrin receptor as markers of iron status, retinol-binding protein as a marker of vitamin A status, and C-reactive protein and α-1 acid glycoprotein from a finger stick blood draw among a subsample (n = 387). We estimated mean difference using linear regression and prevalence ratios using modified Poisson regression accounting for the clustered design. All analyses were intention-to-treat. RESULTS: Children in the LNS groups (T2 and T3) had ∼40% lower prevalence of anemia and iron deficiency anemia and 25% lower prevalence of iron deficiency than children in the control group (T0) (P < 0.05 for all). There were no differences in any of the biomarkers when comparing children in the T4 group with those in T0; nor were there differences between T3 and T2. CONCLUSIONS: Our findings suggest the provision of LNS in the context of a large-scale program offers significant benefits on anemia and iron status in young children.This trial was registered at www.isrctn.com as ISRCTN14393738.

Caregiver perceptions of child development in rural Madagascar: a cross-sectional study.

BACKGROUND: Human capital (the knowledge, skills, and health that accumulate over life) can be optimized by investments in early childhood to promote cognitive and language development. Parents and caregivers play a crucial role in the promotion and support of cognitive development in their children. Thus, understanding caregiver perceptions of a child's capabilities and attributes, including intelligence, may enhance investments early in life. To explore this question, we asked caregivers to rank their child's intelligence in comparison with other children in the community, and compared this ranking with children's scores on an assessment of developmental abilities across multiple domains. METHODS: Our study examined cross-sectional data of 3361 children aged 16-42 months in rural Madagascar. Child intelligence, as perceived by their caregiver, was captured using a ladder ranking scale based on the MacArthur Scale for Subjective Social Status. Children's developmental abilities were assessed using scores from the Ages and Stages Questionnaire: Inventory (ASQ-I), which measures cognitive, language, and socio-emotional development. Ranked percentiles of the ASQ-I were generated within communities and across the whole sample. We created categories of under-estimation, matched, and over-estimation by taking the differences in rankings between caregiver-perceived child intelligence and ASQ-I. Child nutritional status, caregiver belief of their influence on child intelligence, and sociodemographic factors were examined as potential correlates of discordance between the measures using multinomial logistic regressions. RESULTS: We found caregiver perceptions of intelligence in Madagascar did not align consistently with the ASQ-I, with approximately 8% of caregivers under-estimating and almost 50% over-estimating their children's developmental abilities. Child nutritional status, caregiver belief of their influence on child intelligence, caregiver education, and wealth were associated with under- or over-estimation of children's developmental abilities. CONCLUSIONS: Our findings suggest parents may not always have an accurate perception of their child's intelligence or abilities compared with other children. The results are consistent with the limited literature on parental perceptions of child nutrition, which documents a discordance between caregiver perceptions and objective measures. Further research is needed to understand the common cues caregivers that use to identify child development milestones and how these may differ from researcher-observed measures in low-income settings. TRIAL REGISTRATION: Current Controlled Trials ISRCTN14393738 . Registered June 23, 2015.

Perils of scaling up: Effects of expanding a nutrition programme in Madagascar.

Scaling up integrated nutrition programmes from small, targeted interventions or pilot studies to large-scale government-run programmes can be challenging, with risks of changing the nature and quality of the interventions such that effectiveness is not sustained. In 1999, the Government of Madagascar introduced a nationwide, community-based, growth-monitoring and nutrition education programme, which was gradually scaled up throughout the country until 2011. Data from three nationally representative surveys, administered pre- and post-programme implementation, in participating and non-participating communities, were used to evaluate the effectiveness of the programme to reduce malnutrition in children under 5 after two phases of expansion (1999-2004 and 2004-2011). In our analyses, we compared "original" communities, who had initiated the programme during the first phase, and "new" communities, who initiated the programme during the second phase. "Original" communities demonstrated a significant effect on mean weight-for-age and on the prevalence of underweight by 2004; this effect was sustained at a reduced level through 2011. In contrast, "new" communities showed no benefits for any childhood nutritional outcomes. An explanation for these findings may be that community health workers in the "new" communities reported lower motivation and less use of key messages and materials than those in the "original" communities. Frontline workers reported increased workload and irregular pay across the board during the second phase of programme expansion. Our findings underscore the risk of losing effectiveness if programme quality is not maintained during scale-up. Key factors, such as training and motivation of frontline workers, are important to address when bringing a programme to scale.

Validity of caregiver-report measures of language skill for Wolof-learning infants and toddlers living in rural African villages.

Valid indigenous language assessments are needed to further our understanding of how children learn language around the world. We assessed the psychometric properties and performance of two caregiver-report measures of Wolof language skill (language milestones achieved and vocabulary knowledge) for 500 children (ages 0;4 to 2;6) living in rural Senegal. Item response models (IRM) evaluated instrument- and item-level performance and differential function by gender. Both caregiver-report measures had good psychometric properties and displayed expected age and socioeconomic effects. Modest concurrent validity was found by comparing the caregiver-report scores to transcribed child language samples from a naturalistic play session. The caregiver-report method offers a valid alternative to more costly tools, such as direct behavioral assessments or language sampling, for measuring early language development in non-literate, rural African communities. Recommendations are made to further improve the performance of caregiver-report measures of child language skill in these settings.

A cluster-randomized, controlled trial of nutritional supplementation and promotion of responsive parenting in Madagascar: the MAHAY study design and rationale.

BACKGROUND: Over half of the world's children suffer from poor nutrition, and as a consequence they experience delays in physical and mental health, and cognitive development. There is little data evaluating the effects of delivery of lipid-based, nutrition supplementation on growth and development during pregnancy and early childhood within the context of a scaled-up program. Furthermore, there is limited evidence on effects of scaled-up, home-visiting programs that focus on the promotion of child development within the context of an existing, national nutrition program. METHODS/DESIGN: The MAHAY ("smart" in Malagasy) study uses a multi-arm randomized-controlled trial (RCT) to test the effects and cost-effectiveness of combined interventions to address chronic malnutrition and poor child development. The arms of the trial are: (T0) existing program with monthly growth monitoring and nutritional/hygiene education; (T1) is T0 + home visits for intensive nutrition counseling within a behavior change framework; (T2) is T1 + lipid-based supplementation (LNS) for children 6-18 months old; (T3) is T2 + LNS supplementation of pregnant/lactating women; and (T4) is T1 + intensive home visiting program to support child development. There are anticipated to be n = 25 communities in each arm (n = 1250 pregnant women, n = 1250 children 0-6 months old, and n = 1250 children 6-18 months old). Primary outcomes include growth (length/height-for-age z-scores) and child development (mental, motor and social development). Secondary outcomes include care-giver reported child morbidity, household food security and diet diversity, micro-nutrient status, maternal knowledge of child care and feeding practices, and home stimulation practices. We will estimate unadjusted and adjusted intention-to-treat effects. Study protocols have been reviewed and approved by the Malagasy Ethics Committee at the Ministry of Health in Madagascar and by the institutional review board at the University of California, Davis. This study is funded by the Strategic Impact Evaluation Fund (SIEF), the World Bank Innovation Grant, the Early Learning Partnership Grant, the Japan Scaling-up for Nutrition Trustfund, and Grand Challenges Canada. The implementation of the study is financed by Madagascar's National Nutrition Office. TRIAL REGISTRATION: Current Controlled Trials ISRCTN14393738 . Registered June 23, 2015.

Sleepless nights, troubled futures: The association between insufficient sleep and child flourishing.

OBJECTIVE: To examine associations between sleep and flourishing among children ages 0-5 years in the United States and whether these differ by age, developmental needs, and family resilience. STUDY DESIGN AND METHODS: Cross-sectional data from the 2020-2021 National Survey of Children's Health (N = 31,095) were used with survey-weighted logistic regression to explore associations between insufficient sleep (defined as not meeting age-recommended daily sleep guidelines: 12-16 h for 4- to 12-month-olds, 11-14 h for 1- to 2-year-olds, and 10-13 h for 3- to 5-year-olds) and flourishing (using four markers combined and categorized into two groups). Tests of effect measure modification (EMM) were performed on the multiplicative and additive scales. RESULTS: Weak but notable evidence was found that children with insufficient sleep had decreased odds of flourishing (aOR = 0.76; 95 % CI: 0.60, 1.00). No evidence of EMM by child age or family resilience was found. However, the sleep-flourishing association differed significantly by children's developmental needs, suggesting that the combined effect of sleep and developmental needs impact flourishing more than either factor alone. CONCLUSIONS: Approximately 38 % of children ages 0-5 years in the United States are estimated to have insufficient sleep. This study provides evidence that insufficient sleep is associated with decreased flourishing among children with special health care needs (CSHCN). FUTURE IMPLICATIONS: Increasing sleep interventions among children under five is warranted among children with special health care needs. The association between sleep and flourishing within specific CSHCN categories, including emotional, behavioral, or developmental (EBD) criteria, should be explored to optimize sleep policies.

Associations of in-hospital postpartum feeding experiences with exclusive breastfeeding practices among infants in rural Sichuan, China.

BACKGROUND: In rural China, exclusive breastfeeding (EBF) prevalence is low and hospitals often fail to attain baby-friendly feeding objectives, such as ≥ 75% of newborns exclusively breastfed from birth to discharge. Empirical evidence for the impact of increased hospital compliance with recommended feeding guidelines on continued EBF in rural China is lacking. We sought to measure and model the association of newborns' in-hospital feeding experiences with EBF practice in infancy to inform policies for EBF promotion. METHODS: Data were cross-sectional from 785 caregivers of infants < 6 months of age, collected from November to December 2019 in four underdeveloped counties/districts in Sichuan Province. In-hospital feeding practices were determined, and prevalence of current infant feeding practices was calculated from 24-h recall and categorized according to WHO/UNICEF Infant and Young Child Feeding categories as EBF, breastfed with non-milk liquids, mixed feeding, breastfed with solids, and not breastfed. Relative risk ratios were estimated using adjusted multinomial logistic regression to examine risk factors for non-EBF practices compared to EBF, including in-hospital feeding experiences. The regression model was used to investigate change in EBF prevalence under alternative in-hospital experiences. RESULTS: Only 38.1% of under-six-month-old infants were being exclusively breastfed when data were collected; 61.8% and 77.6% had been fed water and infant formula, respectively, in the hospital. Infants who were fed water or formula before discharge were estimated as 2-3 times as likely to be non-EBF than EBF up to age six months. According to our model, EBF prevalence would have increased to 53.7% (95% confidence interval (CI) 46.1, 61.2) had ≥ 75% of infants been exclusively breastfed and water-based feeds eliminated in-hospital. CONCLUSIONS: Given the importance of infants' first feeding experiences in the establishment and continuation of EBF, it is imperative that rural Chinese hospitals actively seek to limit infant formula feeds to medically indicated situations and eliminate water-based feeds.

Trends in the prevalence and social determinants of stunting in India, 2005-2021: findings from three rounds of the National Family Health Survey.

Objectives: To assess social determinants of stunting and the shifts in contributions of socio-demographic factors to national prevalence trends in India between 2005 and 2021. Methods: We leveraged data from three rounds of the National Family Health Survey (NFHS-3: 2005-2006, NFHS-4: 2015-2016, NFHS-5: 2019-2021) for 443 038 children under 5 years. Adjusted logistic regression models and a Kitigawa-Oaxaca-Blinder decomposition were deployed to examine how wealth, residence, belonging to a marginalised social group, maternal education and child sex contributed to changes in stunting prevalence. Results: The decrease in stunting prevalence was notably slower between NFHS-4 and NFHS-5 (annual average rate of reduction (AARR): 1.33%) than between NFHS-3 and NFHS-4 (AARR: 2.20%). The protective effect of high wealth diminished from 2015 onwards but persisted for high maternal education. However, an intersection of higher household wealth and maternal education mitigated stunting to a greater extent than either factor in isolation. Residence only predicted stunting in 2005-2006 with an urban disadvantage (adjusted OR: 1.18; 95% CI: 1.07 to 1.29). Children from marginalised social groups displayed increased likelihoods of stunting, from 6-16% in 2005-2006 to 11-21% in 2015-2016 and 2020-2021. Being male was associated with 6% and 7% increased odds of stunting in 2015-2016 and 2019-2021, respectively. Increased household wealth (45%) and maternal education (14%) contributed to decreased stunting prevalence between 2005 and 2021. Conclusions: Stunting prevalence in India has decreased across social groups. However, social disparities in stunting persist and are exacerbated by intersections of low household wealth, maternal education and being from a marginalised social group. Increased survival must be accompanied by needs-based interventions to support children and mitigate mutually reinforcing sources of inequality.

Effect of the mHealth-supported Healthy Future programme delivered by community health workers on maternal and child health in rural China: study protocol for a cluster randomised controlled trial.

INTRODUCTION: Millions of young rural children in China still suffer from poor health and malnutrition, partly due to a lack of knowledge about optimal perinatal and child care among rural mothers and caregivers. Meanwhile, there is an urgent need to improve maternal mental health in rural communities. Comprehensive home visiting programmes delivered by community health workers (CHWs) can bridge the caregiver knowledge gap and improve child health and maternal well-being in low-resource settings, but the effectiveness of this approach is unknown in rural China. Additionally, grandmothers play important roles in child care and family decision-making in rural China, suggesting the importance of engaging multiple caregivers in interventions. The Healthy Future programme seeks to improve child health and maternal well-being by developing a staged-based curriculum that CHWs deliver to mothers and caregivers of young children through home visits with the assistance of a tablet-based mHealth system. This protocol describes the design and evaluation plan for this programme. METHODS AND ANALYSIS: We designed a cluster-randomised controlled trial among 119 rural townships in four nationally designated poverty counties in Southwestern China. We will compare the outcomes between three arms: one standard arm with only primary caregivers participating in the intervention, one encouragement arm engaging primary and secondary caregivers and one control arm with no intervention. Families with pregnant women or infants under 6 months of age are invited to enrol in the 12-month study. Primary outcomes include children's haemoglobin levels, exclusive breastfeeding rates and dietary diversity in complementary feeding. Secondary outcomes include a combination of health, behavioural and intermediate outcomes. ETHICS AND DISSEMINATION: Ethical approval has been provided by Stanford University, Sichuan University and the University of Nevada, Reno. Trial findings will be disseminated through national and international peer-reviewed publications and conferences. TRIAL REGISTRATION NUMBER: ISRCTN16800789.

In-Hospital Formula Feeding Hindered Exclusive Breastfeeding: Breastfeeding Self-Efficacy as a Mediating Factor.

Breastfeeding self-efficacy (BSE), defined as a mother's confidence in her ability to breastfeed, has been confirmed to predict the uptake of exclusive breastfeeding (EBF). Early experiences during the birth hospital stay, especially in-hospital formula feeding (IHFF), can impact both EBF and maternal breastfeeding confidence. Therefore, our objective was to examine the association between IHFF and EBF outcomes and investigate whether this association is influenced by BSE. The study included 778 infants from a larger cohort study conducted in 2021, with a one-year follow-up in rural areas of Sichuan Province, China. We used a causal mediation analysis to estimate the total effect (TE), natural direct (NDE), and nature indirect effects (NIE) using the paramed command in Stata. Causal mediation analyses revealed that IHFF was negatively associated with EBF (TE odds ratio = 0.47; 95% CI, 0.29 to 0.76); 28% of this association was mediated by BSE. In the subgroup analysis, there were no significant differences in the effects between parity subgroups, as well as between infant delivery subgroups. Our study found that IHFF hindered later EBF and that BSE mediated this association. Limiting the occurrence of in-hospital formula feeding or improving maternal breastfeeding self-efficacy is likely to improve exclusive breastfeeding outcomes.

The creation of the Global Scales for Early Development (GSED) for children aged 0-3 years: combining subject matter expert judgements with big data.

INTRODUCTION: With the ratification of the Sustainable Development Goals, there is an increased emphasis on early childhood development (ECD) and well-being. The WHO led Global Scales for Early Development (GSED) project aims to provide population and programmatic level measures of ECD for 0-3 years that are valid, reliable and have psychometrically stable performance across geographical, cultural and language contexts. This paper reports on the creation of two measures: (1) the GSED Short Form (GSED-SF)-a caregiver reported measure for population-evaluation-self-administered with no training required and (2) the GSED Long Form (GSED-LF)-a directly administered/observed measure for programmatic evaluation-administered by a trained professional. METHODS: We selected 807 psychometrically best-performing items using a Rasch measurement model from an ECD measurement databank which comprised 66 075 children assessed on 2211 items from 18 ECD measures in 32 countries. From 766 of these items, in-depth subject matter expert judgements were gathered to inform final item selection. Specifically collected were data on (1) conceptual matches between pairs of items originating from different measures, (2) developmental domain(s) measured by each item and (3) perceptions of feasibility of administration of each item in diverse contexts. Prototypes were finalised through a combination of psychometric performance evaluation and expert consensus to optimally identify items. RESULTS: We created the GSED-SF (139 items) and GSED-LF (157 items) for tablet-based and paper-based assessments, with an optimal set of items that fit the Rasch model, met subject matter expert criteria, avoided conceptual overlap, covered multiple domains of child development and were feasible to implement across diverse settings. CONCLUSIONS: State-of-the-art quantitative and qualitative procedures were used to select of theoretically relevant and globally feasible items representing child development for children aged 0-3 years. GSED-SF and GSED-LF will be piloted and validated in children across diverse cultural, demographic, social and language contexts for global use.

Protocol for validation of the Global Scales for Early Development (GSED) for children under 3 years of age in seven countries.

INTRODUCTION: Children's early development is affected by caregiving experiences, with lifelong health and well-being implications. Governments and civil societies need population-based measures to monitor children's early development and ensure that children receive the care needed to thrive. To this end, the WHO developed the Global Scales for Early Development (GSED) to measure children's early development up to 3 years of age. The GSED includes three measures for population and programmatic level measurement: (1) short form (SF) (caregiver report), (2) long form (LF) (direct administration) and (3) psychosocial form (PF) (caregiver report). The primary aim of this protocol is to validate the GSED SF and LF. Secondary aims are to create preliminary reference scores for the GSED SF and LF, validate an adaptive testing algorithm and assess the feasibility and preliminary validity of the GSED PF. METHODS AND ANALYSIS: We will conduct the validation in seven countries (Bangladesh, Brazil, Côte d'Ivoire, Pakistan, The Netherlands, People's Republic of China, United Republic of Tanzania), varying in geography, language, culture and income through a 1-year prospective design, combining cross-sectional and longitudinal methods with 1248 children per site, stratified by age and sex. The GSED generates an innovative common metric (Developmental Score: D-score) using the Rasch model and a Development for Age Z-score (DAZ). We will evaluate six psychometric properties of the GSED SF and LF: concurrent validity, predictive validity at 6 months, convergent and discriminant validity, and test-retest and inter-rater reliability. We will evaluate measurement invariance by comparing differential item functioning and differential test functioning across sites. ETHICS AND DISSEMINATION: This study has received ethical approval from the WHO (protocol GSED validation 004583 20.04.2020) and approval in each site. Study results will be disseminated through webinars and publications from WHO, international organisations, academic journals and conference proceedings. REGISTRATION DETAILS: Open Science Framework https://osf.io/ on 19 November 2021 (DOI 10.17605/OSF.IO/KX5T7; identifier: osf-registrations-kx5t7-v1).