Protocol of the Low Birth Weight South Asia Trial (LBWSAT), a cluster-randomised controlled trial testing impact on birth weight and infant nutrition of Participatory Learning and Action through women’s groups, with and without unconditional transfers of fortified food or cash during pregnancy in Nepal

Abstract

BackgroundLow birth weight (LBW, < 2500 g) affects one third of newborn infants in rural south Asia and compromises child survival, infant growth, educational performance and economic prospects. We aimed to assess the impact on birth weight and weight-for-age Z-score in children aged 0–16 months of a nutrition Participatory Learning and Action behaviour change strategy (PLA) for pregnant women through women’s groups, with or without unconditional transfers of food or cash to pregnant women in two districts of southern Nepal.MethodsThe study is a cluster randomised controlled trial (non-blinded). PLA comprises women’s groups that discuss, and form strategies about, nutrition in pregnancy, low birth weight and hygiene. Women receive up to 7 monthly transfers per pregnancy: cash is NPR 750 (~US$7) and food is 10 kg of fortified sweetened wheat-soya Super Cereal per month. The unit of randomisation is a rural village development committee (VDC) cluster (population 4000–9200, mean 6150) in southern Dhanusha or Mahottari districts. 80 VDCs are randomised to four arms using a participatory ‘tombola’ method. Twenty clusters each receive: PLA; PLA plus food; PLA plus cash; and standard care (control). Participants are (mostly Maithili-speaking) pregnant women identified from 8 weeks’ gestation onwards, and their infants (target sample size 8880 birth weights). After pregnancy verification, mothers may be followed up in early and late pregnancy, within 72 h, after 42 days and within 22 months of birth. Outcomes pertain to the individual level. Primary outcomes include birth weight within 72 h of birth and infant weight-for-age Z-score measured cross-sectionally on children born of the study. Secondary outcomes include prevalence of LBW, eating behaviour and weight during pregnancy, maternal and newborn illness, preterm delivery, miscarriage, stillbirth or neonatal mortality, infant Z-scores for length-for-age and weight-for-length, head circumference, and postnatal maternal BMI and mid-upper arm circumference. Exposure to women’s groups, food or cash transfers, home visits, and group interventions are measured.DiscussionDetermining the relative importance to birth weight and early childhood nutrition of adding food or cash transfers to PLA women’s groups will inform design of nutrition interventions in pregnancy.Trial registration ISRCTN75964374, 12 Jul 2013Electronic supplementary materialThe online version of this article (doi:10.1186/s12884-016-1102-x) contains supplementary material, which is available to authorized users.

How Much Education Is Needed to Delay Women's Age at Marriage and First Pregnancy?

“…Previous studies, using 2011 DHS data from Nepal on women aged 15-49 years, found that compared to high caste Hindu women (whose hills/plains ethnicity was not defined), Madhesi women were 51% more likely to marry <16 years of age (33). Maithilispeaking women of reproductive age, especially young and newly married wives generally have limited mobility outside their homes because of cultural norms restricting socialization with outside men (37)(38)(39). They tend to have less access to nutritious foods during pregnancy (40) and little decision-making power over when and what they eat (41).…”

“…The trial assessed the impact of pregnancy interventions on birth weight and weight-for-age z-score in children aged 0-16 months. The trial protocol and main results are described elsewhere (37,42). Briefly, all married women between 10 and 49 years of age residing in 80 Village Development Committees (VDC) in the southern areas of Dhanusha and Mahottari districts who had not had operative family planning, and whose husbands had not had vasectomy were eligible to participate in the trial (37).…”

“…The trial protocol and main results are described elsewhere (37,42). Briefly, all married women between 10 and 49 years of age residing in 80 Village Development Committees (VDC) in the southern areas of Dhanusha and Mahottari districts who had not had operative family planning, and whose husbands had not had vasectomy were eligible to participate in the trial (37). A total of 64,000 eligible women consented to menstrual monitoring and between Dec 2013 and Feb 2015, 25,090 pregnant women were recruited into the trial (37).…”

“…Briefly, all married women between 10 and 49 years of age residing in 80 Village Development Committees (VDC) in the southern areas of Dhanusha and Mahottari districts who had not had operative family planning, and whose husbands had not had vasectomy were eligible to participate in the trial (37). A total of 64,000 eligible women consented to menstrual monitoring and between Dec 2013 and Feb 2015, 25,090 pregnant women were recruited into the trial (37). Women were randomized to one of four arms: (a) Participatory Learning and Action (PLA) behavior change approach in Women's Groups, (b) PLA with unconditional cash transfers, (c) PLA with a fortified blended food supplement, or (d) a control group who had access to usual Government of Nepal health services.…”

“…Research ethics approval for the original trial was obtained from the Nepal Health Research Council (108/2012) and University College London (UCL) Research Ethics Committee (4198/001) (37). Consent for inclusion of villages in the trial was obtained from VDCs.…”