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

Volumn 16, Issue 1, 2016, Pages

  Saville, Naomi M ^a   Shrestha, Bhim P ^b   Style, Sarah ^a   Harris Fry, Helen ^a   Beard, B James ^a   Sengupta, Aman ^b   Jha, Sonali ^b   Rai, Anjana ^b   Paudel, Vikas ^b   Pulkki Brannstrom, Anni Maria ^a   Copas, Andrew ^a   Skordis Worrall, Jolene ^a   Bhandari, Bishnu ^b   Neupane, Rishi ^b   Morrison, Joanna ^a   Gram, Lu ^a   Sah, Raghbendra ^b   Basnet, Machhindra ^b   Harthan, Jayne ^a   Manandhar, Dharma S ^b   Osrin, David ^a   Costello, Anthony ^a   more..

^a UNIVERSITY COLLEGE LONDON   (United Kingdom)

^b Mother and Infant Research Activities MIRA   (Nepal)

Author keywords

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

Indexed keywords

ADOLESCENT; ADULT; ANTHROPOMETRIC PARAMETERS; ARM CIRCUMFERENCE; ARTICLE; BEHAVIOR CHANGE; BIRTH WEIGHT; BODY MASS; CEREAL; CHILD; CLINICAL PROTOCOL; CLUSTER ANALYSIS; COMMUNITY PROGRAM; CONTROLLED STUDY; FEEDING BEHAVIOR; FEMALE; FIRST TRIMESTER PREGNANCY; FOLLOW UP; FORTIFIED FOOD; GESTATIONAL AGE; GESTATIONAL WEIGHT GAIN; HEAD CIRCUMFERENCE; HEALTH IMPACT ASSESSMENT; HOME VISIT; HUMAN; HUMAN EXPERIMENT; HYGIENE; INFANT; INFANT NUTRITION; LENGTH FOR AGE; LOW BIRTH WEIGHT; MATERNAL DISEASE; MATERNAL NUTRITION; MONEY; NEPAL; NEWBORN; NEWBORN MORTALITY; OUTCOME ASSESSMENT; PARTICIPATORY LEARNING AND ACTION; PREGNANCY; PREGNANT WOMAN; PREMATURE LABOR; PREVALENCE; RANDOMIZED CONTROLLED TRIAL; SOYBEAN; SPONTANEOUS ABORTION; STILLBIRTH; THIRD TRIMESTER PREGNANCY; WEIGHT FOR AGE; WEIGHT FOR LENGTH; WHEAT; CHILDBIRTH EDUCATION; LEARNING; MALE; NUTRITIONAL STATUS; PREGNANCY OUTCOME; PROCEDURES; PROGRAM EVALUATION; PSYCHOLOGY; REWARD; YOUNG ADULT;

ADULT; CLUSTER ANALYSIS; FEEDING BEHAVIOR; FEMALE; FOOD, FORTIFIED; HUMANS; INFANT; INFANT NUTRITIONAL PHYSIOLOGICAL PHENOMENA; INFANT, LOW BIRTH WEIGHT; INFANT, NEWBORN; LEARNING; MALE; NEPAL; NUTRITIONAL STATUS; PREGNANCY; PREGNANCY OUTCOME; PRENATAL EDUCATION; PROGRAM EVALUATION; REWARD; WOMEN; YOUNG ADULT;

EID: 84992184144     PISSN: None     EISSN: 14712393     Source Type: Journal    
DOI: 10.1186/s12884-016-1102-x     Document Type: Article

References (52)

1. Manandhar DS, Osrin D, Shrestha BP, Mesko N, Morrison J, Tumbahangphe KM, Tamang S, Thapa S, Shrestha D, Thapa B, et al. Effect of a participatory intervention with women's groups on birth outcomes in Nepal: a cluster randomised controlled trial. Lancet. 2004;364:970-9.
2. Tripathy P, Nair N, Barnett S, Mahapatra R, Borghi J, Rath S, Rath S, Gope R, Mahto D, Prost A, Costello A. Effect of a participatory intervention with women's groups on birth outcomes and maternal depression in Jharkhand and Orissa, India: a cluster randomised controlled trial. Lancet. 2010;375:1182-92.
3. Lewycka S, Mwansambo C, Rosato M, Kazembe P, Phiri T, Mganga A, Chapota H, Kainja E, Malamba F, Newell M-L, et al. Effect of women's groups and volunteer peer counsellors on mortality, morbidity and health behaviours among mothers and children in rural Malawi: the MaiMwana factorial cluster randomised controlled trial. Lancet. 2013;381:1721-35.
4. Fottrell E, Azad K, Kuddus A, Younes L, Shaha S, Nahar T, Aumon B, Hossen M, Beard J, Hossain T. The effect of increased coverage of participatory women's groups on neonatal mortality in Bangladesh: A cluster randomized trial. JAMA pediatrics. 2013;167:816.
5. Prost A, Colbourn T, Seward N, Azad K, Coomarasamy A, Copas A, Houweling TA, Fottrell E, Kuddus A, Lewycka S, et al. Women's groups practising participatory learning and action to improve maternal and newborn health in resource-limited settings: systematic review and meta-analysis. Lancet. 2013;381:1736-46.
6. Houweling TA, Tripathy P, Nair N, Rath S, Rath S, Gope R, Sinha R, Looman CW, Costello A, Prost A. The equity impact of participatory women's groups to reduce neonatal mortality in India: secondary analysis of a cluster-randomised trial. Int J Epidemiol. 2013;42:520-32.
7. Borghi J, Thapa B, Osrin D, Jan S, Morrison J, Tamang S, Shrestha B, Wade A, Manandhar D, Costello A. Economic assessment of a women's group intervention to improve birth outcomes in rural Nepal. Lancet. 2005;366:1882-4.
8. Yasmin S, Osrin D, Paul E, Costello A. Neonatal mortality of low-birth-weight infants in Bangladesh. Bull World Health Organ. 2001;79:608-14.
9. Hack M, Klein NK, Taylor HG. Long-term developmental outcomes of low birth weight infants. Future Child. 1995;5:176-96.
10. Veena SR, Krishnaveni GV, Wills AK, Kurpad AV, Muthayya S, Hill JC, Karat SC, Nagarajaiah KK, Fall CH, Srinivasan K. Association of birthweight and head circumference at birth to cognitive performance in 9-to 10-year-old children in South India: prospective birth cohort study. Pediatr Res. 2010;67:424-9.
11. Black RE, Victora CG, Walker SP, Bhutta ZA, Christian P, de Onis M, Ezzati M, Grantham-McGregor S, Katz J, Martorell R, et al. Maternal and child undernutrition and overweight in low-income and middle-income countries. Lancet. 2013;382:427-51.
12. Victora CG, Adair L, Fall C, Hallal PC, Martorell R, Richter L, Sachdev HS. Maternal and child undernutrition: consequences for adult health and human capital. Lancet. 2008;371:340-57.
13. Lawn JE, Cousens S, Zupan J, Lancet Neonatal Survival Steering Team. 4 million neonatal deaths: When? Where? Why? Lancet. 2005;365:891-900.
14. Girard AW, Olude O. Nutrition education and counselling provided during pregnancy: effects on maternal, neonatal and child health outcomes. Paediatr Perinat Epidemiol. 2012;26 Suppl 1:191-204.
15. Shrestha B, Bhandari B, Manandhar D, Osrin D, Costello A, Saville N. Community interventions to reduce child mortality in Dhanusha, Nepal: study protocol for a cluster randomized controlled trial. Trials. 2011;12:136.
16. Over D. Food for thought: a qualitative study that explores dietary beliefs and behaviour among Maithili pregnant women in Nepal. MSc Thesis. London: University College London, Centre for International Child Health; 2002.
17. Ceesay SM, Prentice AM, Cole TJ, Foord F, Weaver LT, Poskitt EM, Whitehead RG. Effects on birth weight and perinatal mortality of maternal dietary supplements in rural Gambia: 5 year randomised controlled trial. BMJ. 1997;315:786-90.
18. Ota E, Tobe-Gai R, Mori R, Farrar D. Antenatal dietary advice and supplementation to increase energy and protein intake. Cochrane Database Syst Rev. 2012;9:CD000032.
19. Persson LÅ, Arifeen S, Ekström E-C, Rasmussen KM, Frongillo EA, Team MS. Effects of prenatal micronutrient and early food supplementation on maternal hemoglobin, birth weight, and infant mortality among children in Bangladesh: the MINIMat randomized trial. JAMA. 2012;307:2050-9.
20. Stein AD, Barnhart HX, Hickey M, Ramakrishnan U, Schroeder DG, Martorell R. Prospective study of protein-energy supplementation early in life and of growth in the subsequent generation in Guatemala. Am J Clin Nutr. 2003;78:162-7.
21. Liberato SC, Singh G, Mulholland K. Effects of protein energy supplementation during pregnancy on fetal growth: a review of the literature focusing on contextual factors. Food Nutr Res. 2013; 57.
22. Barber SL, Gertler PJ. The impact of Mexico's conditional cash transfer programme, Oportunidades, on birthweight (Impact du Programme de Transfert Conditionnel d'Espèces Oportunidades au Mexique sur le poids de naissance /El impacto del programa Mejicano de transferencia monetaria condicionada, Oportunidades, sobre el peso al nacer). Trop Med Int Health. 2008;13:1405-14.
23. Amarante V, Manacorda M, Miguel E, Vigorito A. Do Cash Transfers Improve Birth Outcomes? Evidence from Matched Vital Statistics, Program, and Social Security Data. American Economic Journal: Economic Policy. 2016;8:1-43.
24. Barber SL, Gertler PJ. Empowering women to obtain high quality care: evidence from an evaluation of Mexico's conditional cash transfer programme. Health Policy Plan. 2009;24:18-25.
25. National Planning Commission Secretariat (Nepal). National Population and Housing Census 2011: Village Development Committee/Municipality. In Book National Population and Housing Census 2011: Village Development Committee/Municipality, vol. 02, NPHC 2011. Central Bureau of Statistics; 2012.
26. National Planning Commission Secretariat (Nepal): National Population and Housing Census 2011: National Report. In Book National Population and Housing Census 2011: National Report, vol. 01, NPHC 2011. Central Bureau of Statistics; 2012.
27. Gittelsohn J, Thapa M, Landman L. Cultural factors, caloric intake and micronutrient sufficiency in rural Nepali households. Soc Sci Med. 1997;44:1739-49.
28. Gittelsohn J. Opening the box: intrahousehold food allocation in rural Nepal. Soc Sci Med. 1991;33:1141-54.
29. Ministry of Health and Population (MOHP) [Nepal] NE, and ICF International Inc. Nepal Demographic and Health Survey 2011. In Book Nepal Demographic and Health Survey 2011. Ministry of Health and Population, New ERA, and ICF International, Calverton; 2012.
30. Morrison J, Thapa R, Hartley S, Osrin D, Manandhar M, Tumbahangphe K, Neupane R, Budhathoki B, Sen A, Pace N, et al. Understanding how women's groups improve maternal and newborn health in Makwanpur, Nepal: a qualitative study. Int Health. 2010;2:25-35.
31. Rosato M, Mwansambo CW, Kazembe PN, Phiri T, Soko QS, Lewycka S, Kunyenge BE, Vergnano S, Osrin D, Newell ML, Costello AM. Women's groups' perceptions of maternal health issues in rural Malawi. Lancet. 2006;368:1180-8.
32. Chastre C, Duffield A, Kindness H, LeJeune S, Taylor A. The Minimum Cost of a Healthy Diet: findings from piloting a new methodology in four study locations. London: Save the Children UK; 2007.
33. Save the Children UK: The Cost of diet: A practitioner's guide. In Book The Cost of diet: A practitioner's guide (Editor ed.^eds.). City; 2011
34. Nepal Rastra Bank: Economic Report 2008-9. In Book Economic Report 2008-9 (Editor ed.^eds.). City; 2009
35. Pawson R, Tilley N. Realistic evaluation. London: Sage; 1997.
36. Potdar RD, Sahariah SA, Gandhi M, Kehoe SH, Brown N, Sane H, Dayama M, Jha S, Lawande A, Coakley PJ. Improving women's diet quality preconceptionally and during gestation: effects on birth weight and prevalence of low birth weight-a randomized controlled efficacy trial in India (Mumbai Maternal Nutrition Project). Am J Clin Nutr. 2014;100:1257-68.
37. Amano S, Shrestha BP, Chaube SS, Higuchi M, Manandhar DS, Osrin D, Costello A, Saville N. Effectiveness of female community health volunteers in the detection and management of low-birth-weight in Nepal. Rural Remote Health. 2014;14:2508.
38. Osrin D, Vaidya A, Shrestha Y, Baniya RB, Manandhar DS, Adhikari RK, Filteau S, Tomkins A, Costello AM. Effects of antenatal multiple micronutrient supplementation on birthweight and gestational duration in Nepal: double-blind, randomised controlled trial. Lancet. 2005;365:955-62.
39. Fall CH, Fisher DJ, Osmond C, Margetts BM. Multiple micronutrient supplementation during pregnancy in low-income countries: a meta-analysis of effects on birth size and length of gestation. Food Nutr Bull. 2009;30:S533-46.
40. Imdad A, Bhutta ZA. Effect of balanced protein energy supplementation during pregnancy on birth outcomes. BMC Public Health. 2011;11 Suppl 3:S17.
41. Malin GL, Morris RK, Riley R, Teune MJ, Khan KS. When is birthweight at term abnormally low? A systematic review and meta-analysis of the association and predictive ability of current birthweight standards for neonatal outcomes. BJOG. 2014;121:515-26.
42. Alexander GR, Kogan M, Bader D, Carlo W, Allen M, Mor J. US birth weight/gestational age-specific neonatal mortality: 1995-1997 rates for whites, hispanics, and blacks. Pediatrics. 2003;111:e61-6.
43. Noel-Weiss J, Courant G, Woodend AK. Physiological weight loss in the breastfed neonate: a systematic review. Open Med. 2008;2:e99.
44. Macdonald P, Ross S, Grant L, Young D. Neonatal weight loss in breast and formula fed infants. Arch Dis Child Fetal Neonatal Ed. 2003;88:F472-6.
45. Bertini G, Breschi R, Dani C. Physiological weight loss chart helps to identify high-risk infants who need breastfeeding support. Acta Paediatr. 2014.
46. Grossman X, Chaudhuri JH, Feldman-Winter L, Merewood A. Neonatal weight loss at a US Baby-Friendly Hospital. J Acad Nutr Diet. 2012;112:410-3.
47. Rodriguez G, Ventura P, Samper MP, Moreno L, Sarria A, Perez-Gonzalez JM. Changes in body composition during the initial hours of life in breast-fed healthy term newborns. Biol Neonate. 2000;77:12-6.
48. Batura N, Hill Z, Haghparast-Bidgoli H, Lingam R, Colbourn T, Kim S, Sikander S, Pulkki-Brannstrom A-M, Rahman A, Kirkwood B: Highlighting the evidence gap: how cost-effective are interventions to improve early childhood nutrition and development? Health policy and planning. 2015;30:813-821.
49. Batura N, Pulkki-Brannstrom AM, Agrawal P, Bagra A, Haghparast-Bidgoli H, Bozzani F, Colbourn T, Greco G, Hossain T, Sinha R, et al. Collecting and analysing cost data for complex public health trials: reflections on practice. Glob Health Action. 2014;7:23257.
50. Joint F, Organization WH: Vitamin and mineral requirements in human nutrition. 2005
51. WMA Declaration of Helsinki. Ethical principles for medical research involving human subjects. http://www.wma.net/en/30publications/10policies/b3/. Accessed 13 Oct 2016.
52. World Medical Association. Declaration of Helsinki. Ethical principles for medical research involving human subjects. Bull World Health Organ. 2001;79:373-4.