Abstract
BackgroundThe period from conception to two years of life denotes a critical window of opportunity for promoting optimal growth and development of children. Poor nutrition and health in women of reproductive age and during pregnancy can negatively impact birth outcomes and subsequent infant survival, health and growth. Studies to improve birth outcomes and to achieve optimal growth and development in young children have usually tested the effect of standalone interventions in pregnancy and/or the postnatal period. It is not clearly known whether evidence-based interventions in the different domains such as health, nutrition, water sanitation and hygiene (WASH) and psychosocial care, when delivered together have a synergistic effect. Further, the effect of delivery of an intervention package in the pre and peri-conception period is not fully understood. This study was conceived with an aim to understand the impact of an integrated intervention package, delivered across the pre and peri-conception period, through pregnancy and till 24 months of child age on birth outcomes, growth and development in children.MethodsAn individually randomized controlled trial with factorial design is being conducted in urban and peri-urban low- to mid-socioeconomic neighbourhoods in South Delhi, India. 13,500 married women aged 18 to 30 years will be enrolled and randomized to receive either the pre and peri-conception intervention package or routine care (first randomization). Interventions will be delivered until women are confirmed to be pregnant or complete 18 months of follow up. Once pregnancy is confirmed, women are randomized again (second randomization) to receive either the intervention package for pregnancy and postnatal period or to routine care. Newborns will be followed up till 24 months of age. The interventions are delivered through different study teams. Outcome data are collected by an independent outcome ascertainment team.DiscussionThis study will demonstrate the improvement that can be achieved when key factors known to limit child growth and development are addressed together, throughout the continuum from pre and peri-conception until early childhood. The findings will increase our scientific understanding and provide guidance to nutrition programs in low- and middle-income settings.Trial registrationClinical Trial Registry – India #CTRI/2017/06/008908; Registered 23 June 2017, http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=19339&EncHid=&userName=society%20for%20applied%20studies
Highlights
The period from conception to two years of life denotes a critical window of opportunity for promoting optimal growth and development of children
The primary objective is to determine the effect of integrated and concurrent delivery of interventions to improve health, nutrition, water sanitation and hygiene (WASH) and psychosocial status during the pre- and peri-conception period alone; during pregnancy and early childhood and; throughout the pre- and peri-conception period, pregnancy and early childhood, on preterm birth, Low birth weight (LBW) and SGA, and stunting at 24 months of age compared to routine care and to assess whether the effect of these interventions differs by maternal stature (< 150 cm or ≥ 150 cm)
We propose to enrol a total of 13,500 eligible women (6750 in pre- and peri-conception intervention package group and 6750 in control group) based on the following assumptions: 45% of reproductive-age women randomized get pregnant in the 18 months of the pre- and periconception intervention period, 30% loss between pregnancy and live birth and 20% loss between birth and 24 months of age
Summary
The period from conception to two years of life denotes a critical window of opportunity for promoting optimal growth and development of children. Studies to improve birth outcomes and to achieve optimal growth and development in young children have usually tested the effect of standalone interventions in pregnancy and/or the postnatal period. It is not clearly known whether evidence-based interventions in the different domains such as health, nutrition, water sanitation and hygiene (WASH) and psychosocial care, when delivered together have a synergistic effect. This study was conceived with an aim to understand the impact of an integrated intervention package, delivered across the pre and peri-conception period, through pregnancy and till 24 months of child age on birth outcomes, growth and development in children. Low birth weight (LBW) resulting from both preterm birth and intrauterine growth retardation is a predictor of linear growth in early childhood and an important risk factor for stunting and poor cognitive development, in addition to its substantial contribution to mortality [11,12,13]
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