title: 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: Low 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.
  
  
  
  The 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.
  
  
  
  Determining 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.
  
  
  
  ISRCTN75964374 , 12 Jul 2013.
authors: University College London, Institute for Global Health, London, UK. n.saville@ucl.ac.uk.
authors: Naomi M
authors: NM
authors: Saville
authors: Mother and Infant Research Activities (MIRA), PO Box 921, Thapathali, Kathmandu, Nepal.
authors: Bhim P
authors: BP
authors: Shrestha
authors: University College London, Institute for Global Health, London, UK.
authors: Sarah
authors: S
authors: Style
authors: University College London, Institute for Global Health, London, UK.
authors: Helen
authors: H
authors: Harris-Fry
authors: University College London, Institute for Global Health, London, UK.
authors: B James
authors: BJ
authors: Beard
authors: Mother and Infant Research Activities (MIRA), PO Box 921, Thapathali, Kathmandu, Nepal.
authors: Aman
authors: A
authors: Sengupta
authors: Mother and Infant Research Activities (MIRA), PO Box 921, Thapathali, Kathmandu, Nepal.
authors: Sonali
authors: S
authors: Jha
authors: Mother and Infant Research Activities (MIRA), PO Box 921, Thapathali, Kathmandu, Nepal.
authors: Anjana
authors: A
authors: Rai
authors: Mother and Infant Research Activities (MIRA), PO Box 921, Thapathali, Kathmandu, Nepal.
authors: Vikas
authors: V
authors: Paudel
authors: University College London, Institute for Global Health, London, UK.
authors: Anni-Maria
authors: AM
authors: Pulkki-Brannstrom
authors: University College London, Institute for Global Health, London, UK.
authors: Andrew
authors: A
authors: Copas
authors: University College London, Institute for Global Health, London, UK.
authors: Jolene
authors: J
authors: Skordis-Worrall
authors: Mother and Infant Research Activities (MIRA), PO Box 921, Thapathali, Kathmandu, Nepal.
authors: Bishnu
authors: B
authors: Bhandari
authors: Mother and Infant Research Activities (MIRA), PO Box 921, Thapathali, Kathmandu, Nepal.
authors: Rishi
authors: R
authors: Neupane
authors: University College London, Institute for Global Health, London, UK.
authors: Joanna
authors: J
authors: Morrison
authors: University College London, Institute for Global Health, London, UK.
authors: Lu
authors: L
authors: Gram
authors: Mother and Infant Research Activities (MIRA), PO Box 921, Thapathali, Kathmandu, Nepal.
authors: Raghbendra
authors: R
authors: Sah
authors: Mother and Infant Research Activities (MIRA), PO Box 921, Thapathali, Kathmandu, Nepal.
authors: Machhindra
authors: M
authors: Basnet
authors: University College London, Institute for Global Health, London, UK.
authors: Jayne
authors: J
authors: Harthan
authors: Mother and Infant Research Activities (MIRA), PO Box 921, Thapathali, Kathmandu, Nepal.
authors: Dharma S
authors: DS
authors: Manandhar
authors: University College London, Institute for Global Health, London, UK.
authors: David
authors: D
authors: Osrin
authors: University College London, Institute for Global Health, London, UK.
authors: Anthony
authors: A
authors: Costello
mesh_terms: D000328:Adult; D016000:Cluster Analysis; D005247:Feeding Behavior / Q000523:psychology*; D005260:Female; D005527:Food, Fortified; D006801:Humans; D007223:Infant; D007227:Infant Nutritional Physiological Phenomena; D007230:Infant, Low Birth Weight; D007231:Infant, Newborn; D007858:Learning; D008297:Male; D009390:Nepal; D009752:Nutritional Status; D011247:Pregnancy; D011256:Pregnancy Outcome; D064186:Prenatal Education / Q000379:methods*; D015397:Program Evaluation / Q000379:methods; D012201:Reward; D014930:Women; D055815:Young Adult
keywords: Cash transfer; Food supplement; Low birth weight; Maternal health; Nepal; Newborn; Nutrition; Pregnancy