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

BMC Pregnancy and Childbirth

Study Protocol

Bishnu Bhandari¹  Sonali Jha¹  Machhindra Basnet¹  Rishi Neupane¹  Dharma S. Manandhar¹  Aman Sengupta¹  Anjana Rai¹  Raghbendra Sah¹  Bhim P. Shrestha¹  Vikas Paudel¹  B. James Beard²  David Osrin²  Joanna Morrison²  Naomi M. Saville²  Jolene Skordis-Worrall²  Helen Harris-Fry²  Anthony Costello²  Anni-Maria Pulkki-Brannstrom²  Jayne Harthan²  Lu Gram²  Sarah Style²  Andrew Copas² 

[1] Mother and Infant Research Activities (MIRA), PO Box 921, Thapathali, Kathmandu, Nepal;University College London, Institute for Global Health, London, UK;

关键词: Low birth weight;    Pregnancy;    Nutrition;    Maternal health;    Newborn;    Cash transfer;    Food supplement;    Nepal;   

DOI  :  10.1186/s12884-016-1102-x

 received in 2015-08-31, accepted in 2016-10-08,  发布年份 2016

来源: Springer

【 摘 要 】

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 registrationISRCTN75964374, 12 Jul 2013

【 授权许可】

CC BY   
© The Author(s). 2016