Impact of a package of health, nutrition, psychosocial support, and WaSH interventions delivered during preconception, pregnancy, and early childhood periods on birth outcomes and on linear growth at 24 months of age: factorial, individually randomised controlled trial

Abstract

Objective To determine the effect of integrated and concurrent delivery of health, nutrition, water, sanitation and hygiene (WaSH), and psychosocial care interventions during the preconception period alone, during pregnancy and early childhood, and throughout preconception, pregnancy, and early childhood on birth outcomes and linear growth at 24 months of age compared with routine care. Design Individually randomised factorial trial. Setting Low and middle income neighbourhoods of Delhi, India. Participants 13 500 women were randomised to receive preconception interventions (n=6722) or routine care (n=6778). 2652 and 2269 pregnant women were randomised again to receive pregnancy and early childhood interventions or routine care. The analysis of birth outcomes included 1290 live births for the preconception, pregnancy, and early childhood interventions (group A), 1276 for the preconception intervention (group B), 1093 for the pregnancy and early childhood interventions (group C), and 1093 for the control (group D). Children aged 24 months by 30 June 2021 were included in the 24 month outcome analysis (453 in group A, 439 in B, 293 in C, and 271 in D). Interventions Health, nutrition, psychosocial care and support, and WaSH interventions were delivered during preconception, pregnancy, and early childhood periods. Main outcome measures The primary outcomes were low birth weight, small for gestational age, preterm, and mean birth weight. At 24 months, the outcomes were mean length-for-age z scores and proportion stunted. Three prespecified comparisons were made: preconception intervention groups (A+B) versus no preconception intervention groups (C+D); pregnancy and early childhood intervention groups (A+C) versus routine care during pregnancy and early childhood (B+D) and preconception, pregnancy, and early childhood interventions groups (A) versus control group (D). Results The proportion with low birth weight was lower in the preconception intervention groups (506/2235) than in the no preconception intervention groups (502/1889; incidence rate ratio 0.85, 98.3% confidence interval 0.75 to 0.97; absolute risk reduction −3.80%, 98.3% confidence interval −6.99% to −0.60%). The proportion with low birth weight was lower in the pregnancy intervention groups (502/2096) than in the no pregnancy intervention groups (506/2028) but the upper limit of the confidence interval crossed null effect (0.87, 0.76 to 1.01; −1.71%, −4.96% to 1.54%). There was a larger effect on proportion with low birth weight in the group that received interventions in the preconception and pregnancy periods (267/1141) compared with the control group (267/934; 0.76, 0.62 to 0.91; −5.59%, −10.32% to −0.85%). The proportion stunted at 24 months of age was substantially lower in the pregnancy and early childhood intervention groups (79/746) compared with the groups that did not receive these interventions (136/710; 0.51, 0.38 to 0.70; −8.32%, −12.31% to −4.32%), and in the group that received preconception, pregnancy, and early childhood interventions (47/453) compared with the control group (51/271; 0.49, 0.32 to 0.75; −7.98%, −14.24% to −1.71%). No effect on stunting at 24 months was observed in the preconception intervention groups (132/892) compared with the no preconception intervention groups (83/564). Conclusions An intervention package delivered during preconception, pregnancy, and early childhood substantially reduced low birth weight and stunting at 24 months. Pregnancy and early childhood interventions alone had lower but important effects on birth outcomes and 24 month outcomes. Preconception interventions alone had an important effect on birth outcomes but not on 24 month outcomes. Trial registration Clinical Trial Registry—India CTRI/2017/06/008908.

A Pooled Data Analysis to Determine Risk Factors of Childhood Stunting in Indonesia

“…28 In 2013, The World Health Assembly stated that scaling up nutrition during the first 1000 days of life through specifics and sensitive intervention was the most cost-efficient period to eradicate the stunting of children, optimum brain development, prevent degenerative diseases in adulthood, and encourage the best human resources for developing the nations 29 as well as a previous study proved. [30][31] So that, interventions for stunting and severe stunting children in both rural and urban areas will be more effective in the first 1000 days as a period that is considered a golden opportunity and crucial for the development of an individual's brain.…”

Optimizing Interventions for Early Childhood Development

“…Regardless, the current results of the trial underline an important role of comprehensive care particularly in pregnancy and early childhood to improve developmental outcomes among children, with important implications for low- and middle-income populations. Importantly, these are in addition to significant effects on maternal health in pregnancy, birth weight, birth weight for gestational age, and early childhood growth that were reported previously . Although questions remain regarding exactly how early before pregnancy to intervene and how much to include in interventions, the WINGS trial indicates that investing in integrated interventions is key for early childhood health and development.…”

“…Although this suggests smaller influences of preconception vs later interventions on early childhood development, this does not rule out the potential importance of focusing on the preconception period, for several reasons. Preconception interventions in the WINGS trial were initiated on average at about 4 months prior to conception, and it is unclear whether duration of delivery may influence impact. Furthermore, delivery of the intervention package in preconception resulted in reduced risks of low birth weight and small-for-gestational age, indicating important benefit for neonatal health, although results from the current analysis suggest that this may not translate into neurodevelopmental benefits in early childhood…”

“…A preconception approach also provides an opportunity to address other risks by integrating strategies to promote appropriate timing and spacing of pregnancies, reducing the likelihood of adverse pregnancy outcomes, with subsequent implications for early childhood development . Although the WINGS trial included a family planning component for specific subgroups, prior data indicate that risks related to inadequate pregnancy spacing were relatively low in the study population, with an average interpregnancy interval of at least 33 months. Other potential benefits are also evident when taking a broader view and recognizing the overlap between preconception and adolescence.…”

Birth weight and hypertension: nature or nurture?

“…Finally, also, intervention studies are needed to prove the importance of preventive maternal and child healthcare for these measures and outcomes. This was recently shown in a randomized study from India when such preventive efforts during preconception and pregnancy improved not only birth outcomes but also maternal health [29]. Thus, cardiovascular prevention should start early in life, even before birth.…”