title: 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).
abstract: BACKGROUND
  Low birth weight (LBW) is an important public health problem in undernourished populations.
  
  
  OBJECTIVE
  We tested whether improving women's dietary micronutrient quality before conception and throughout pregnancy increases birth weight in a high-risk Indian population.
  
  
  METHODS
  The study was a nonblinded, individually randomized controlled trial. The intervention was a daily snack made from green leafy vegetables, fruit, and milk (treatment group) or low-micronutrient vegetables (potato and onion) (control group) from ≥ 90 d before pregnancy until delivery in addition to the usual diet. Treatment snacks contained 0.69 MJ of energy (controls: 0.37 MJ) and 10-23% of WHO Reference Nutrient Intakes of β-carotene, riboflavin, folate, vitamin B-12, calcium, and iron (controls: 0-7%). The primary outcome was birth weight.
  
  
  RESULTS
  Of 6513 women randomly assigned, 2291 women became pregnant, 1962 women delivered live singleton newborns, and 1360 newborns were measured. In an intention-to-treat analysis, there was no overall increase in birth weight in the treatment group (+26 g; 95% CI: -15, 68 g; P = 0.22). There was an interaction (P < 0.001) between the allocation group and maternal prepregnant body mass index (BMI; in kg/m(2)) [birth-weight effect: -23, +34, and +96 g in lowest (<18.6), middle (18.6-21.8), and highest (>21.8) thirds of BMI, respectively]. In 1094 newborns whose mothers started supplementation ≥ 90 d before pregnancy (per-protocol analysis), birth weight was higher in the treatment group (+48 g; 95% CI: 1, 96 g; P = 0.046). Again, the effect increased with maternal BMI (-8, +79, and +113 g; P-interaction = 0.001). There were similar results for LBW (intention-to-treat OR: 0.83; 95% CI: 0.66, 1.05; P = 0.10; per-protocol OR = 0.76; 95% CI: 0.59, 0.98; P = 0.03) but no effect on gestational age in either analysis.
  
  
  CONCLUSIONS
  A daily snack providing additional green leafy vegetables, fruit, and milk before conception and throughout pregnancy had no overall effect on birth weight. Per-protocol and subgroup analyses indicated a possible increase in birth weight if the mother was supplemented ≥ 3 mo before conception and was not underweight. This trial was registered at www.controlled-trials.com/isrctn/ as ISRCTN62811278.
authors.affiliation: From the Centre for the Study of Social Change, Mumbai, India (RDP, SAS, MG, HS, MD, SJ, AL, HC, DS, PC-G, PM-L, and GS); the Medical Research Council Lifecourse Epidemiology Unit (SHK, NB, PJC, EM-Z, AKW, VAC, DJPB, and CHDF), the National Institute for Health Research Southampton Biomedical Research Centre (AAJ), and Public Health Nutrition, Faculty of Medicine (BMM), University of Southampton, Southampton, United Kingdom; and Streehitakarini, Mumbai, India (VT).
authors.forename: Ramesh D
authors.initials: RD
authors.lastname: Potdar
authors.affiliation: From the Centre for the Study of Social Change, Mumbai, India (RDP, SAS, MG, HS, MD, SJ, AL, HC, DS, PC-G, PM-L, and GS); the Medical Research Council Lifecourse Epidemiology Unit (SHK, NB, PJC, EM-Z, AKW, VAC, DJPB, and CHDF), the National Institute for Health Research Southampton Biomedical Research Centre (AAJ), and Public Health Nutrition, Faculty of Medicine (BMM), University of Southampton, Southampton, United Kingdom; and Streehitakarini, Mumbai, India (VT).
authors.forename: Sirazul A
authors.initials: SA
authors.lastname: Sahariah
authors.affiliation: From the Centre for the Study of Social Change, Mumbai, India (RDP, SAS, MG, HS, MD, SJ, AL, HC, DS, PC-G, PM-L, and GS); the Medical Research Council Lifecourse Epidemiology Unit (SHK, NB, PJC, EM-Z, AKW, VAC, DJPB, and CHDF), the National Institute for Health Research Southampton Biomedical Research Centre (AAJ), and Public Health Nutrition, Faculty of Medicine (BMM), University of Southampton, Southampton, United Kingdom; and Streehitakarini, Mumbai, India (VT).
authors.forename: Meera
authors.initials: M
authors.lastname: Gandhi
authors.affiliation: From the Centre for the Study of Social Change, Mumbai, India (RDP, SAS, MG, HS, MD, SJ, AL, HC, DS, PC-G, PM-L, and GS); the Medical Research Council Lifecourse Epidemiology Unit (SHK, NB, PJC, EM-Z, AKW, VAC, DJPB, and CHDF), the National Institute for Health Research Southampton Biomedical Research Centre (AAJ), and Public Health Nutrition, Faculty of Medicine (BMM), University of Southampton, Southampton, United Kingdom; and Streehitakarini, Mumbai, India (VT).
authors.forename: Sarah H
authors.initials: SH
authors.lastname: Kehoe
authors.affiliation: From the Centre for the Study of Social Change, Mumbai, India (RDP, SAS, MG, HS, MD, SJ, AL, HC, DS, PC-G, PM-L, and GS); the Medical Research Council Lifecourse Epidemiology Unit (SHK, NB, PJC, EM-Z, AKW, VAC, DJPB, and CHDF), the National Institute for Health Research Southampton Biomedical Research Centre (AAJ), and Public Health Nutrition, Faculty of Medicine (BMM), University of Southampton, Southampton, United Kingdom; and Streehitakarini, Mumbai, India (VT).
authors.forename: Nick
authors.initials: N
authors.lastname: Brown
authors.affiliation: From the Centre for the Study of Social Change, Mumbai, India (RDP, SAS, MG, HS, MD, SJ, AL, HC, DS, PC-G, PM-L, and GS); the Medical Research Council Lifecourse Epidemiology Unit (SHK, NB, PJC, EM-Z, AKW, VAC, DJPB, and CHDF), the National Institute for Health Research Southampton Biomedical Research Centre (AAJ), and Public Health Nutrition, Faculty of Medicine (BMM), University of Southampton, Southampton, United Kingdom; and Streehitakarini, Mumbai, India (VT).
authors.forename: Harshad
authors.initials: H
authors.lastname: Sane
authors.affiliation: From the Centre for the Study of Social Change, Mumbai, India (RDP, SAS, MG, HS, MD, SJ, AL, HC, DS, PC-G, PM-L, and GS); the Medical Research Council Lifecourse Epidemiology Unit (SHK, NB, PJC, EM-Z, AKW, VAC, DJPB, and CHDF), the National Institute for Health Research Southampton Biomedical Research Centre (AAJ), and Public Health Nutrition, Faculty of Medicine (BMM), University of Southampton, Southampton, United Kingdom; and Streehitakarini, Mumbai, India (VT).
authors.forename: Monika
authors.initials: M
authors.lastname: Dayama
authors.affiliation: From the Centre for the Study of Social Change, Mumbai, India (RDP, SAS, MG, HS, MD, SJ, AL, HC, DS, PC-G, PM-L, and GS); the Medical Research Council Lifecourse Epidemiology Unit (SHK, NB, PJC, EM-Z, AKW, VAC, DJPB, and CHDF), the National Institute for Health Research Southampton Biomedical Research Centre (AAJ), and Public Health Nutrition, Faculty of Medicine (BMM), University of Southampton, Southampton, United Kingdom; and Streehitakarini, Mumbai, India (VT).
authors.forename: Swati
authors.initials: S
authors.lastname: Jha
authors.affiliation: From the Centre for the Study of Social Change, Mumbai, India (RDP, SAS, MG, HS, MD, SJ, AL, HC, DS, PC-G, PM-L, and GS); the Medical Research Council Lifecourse Epidemiology Unit (SHK, NB, PJC, EM-Z, AKW, VAC, DJPB, and CHDF), the National Institute for Health Research Southampton Biomedical Research Centre (AAJ), and Public Health Nutrition, Faculty of Medicine (BMM), University of Southampton, Southampton, United Kingdom; and Streehitakarini, Mumbai, India (VT).
authors.forename: Ashwin
authors.initials: A
authors.lastname: Lawande
authors.affiliation: From the Centre for the Study of Social Change, Mumbai, India (RDP, SAS, MG, HS, MD, SJ, AL, HC, DS, PC-G, PM-L, and GS); the Medical Research Council Lifecourse Epidemiology Unit (SHK, NB, PJC, EM-Z, AKW, VAC, DJPB, and CHDF), the National Institute for Health Research Southampton Biomedical Research Centre (AAJ), and Public Health Nutrition, Faculty of Medicine (BMM), University of Southampton, Southampton, United Kingdom; and Streehitakarini, Mumbai, India (VT).
authors.forename: Patsy J
authors.initials: PJ
authors.lastname: Coakley
authors.affiliation: From the Centre for the Study of Social Change, Mumbai, India (RDP, SAS, MG, HS, MD, SJ, AL, HC, DS, PC-G, PM-L, and GS); the Medical Research Council Lifecourse Epidemiology Unit (SHK, NB, PJC, EM-Z, AKW, VAC, DJPB, and CHDF), the National Institute for Health Research Southampton Biomedical Research Centre (AAJ), and Public Health Nutrition, Faculty of Medicine (BMM), University of Southampton, Southampton, United Kingdom; and Streehitakarini, Mumbai, India (VT).
authors.forename: Ella
authors.initials: E
authors.lastname: Marley-Zagar
authors.affiliation: From the Centre for the Study of Social Change, Mumbai, India (RDP, SAS, MG, HS, MD, SJ, AL, HC, DS, PC-G, PM-L, and GS); the Medical Research Council Lifecourse Epidemiology Unit (SHK, NB, PJC, EM-Z, AKW, VAC, DJPB, and CHDF), the National Institute for Health Research Southampton Biomedical Research Centre (AAJ), and Public Health Nutrition, Faculty of Medicine (BMM), University of Southampton, Southampton, United Kingdom; and Streehitakarini, Mumbai, India (VT).
authors.forename: Harsha
authors.initials: H
authors.lastname: Chopra
authors.affiliation: From the Centre for the Study of Social Change, Mumbai, India (RDP, SAS, MG, HS, MD, SJ, AL, HC, DS, PC-G, PM-L, and GS); the Medical Research Council Lifecourse Epidemiology Unit (SHK, NB, PJC, EM-Z, AKW, VAC, DJPB, and CHDF), the National Institute for Health Research Southampton Biomedical Research Centre (AAJ), and Public Health Nutrition, Faculty of Medicine (BMM), University of Southampton, Southampton, United Kingdom; and Streehitakarini, Mumbai, India (VT).
authors.forename: Devi
authors.initials: D
authors.lastname: Shivshankaran
authors.affiliation: From the Centre for the Study of Social Change, Mumbai, India (RDP, SAS, MG, HS, MD, SJ, AL, HC, DS, PC-G, PM-L, and GS); the Medical Research Council Lifecourse Epidemiology Unit (SHK, NB, PJC, EM-Z, AKW, VAC, DJPB, and CHDF), the National Institute for Health Research Southampton Biomedical Research Centre (AAJ), and Public Health Nutrition, Faculty of Medicine (BMM), University of Southampton, Southampton, United Kingdom; and Streehitakarini, Mumbai, India (VT).
authors.forename: Purvi
authors.initials: P
authors.lastname: Chheda-Gala
authors.affiliation: From the Centre for the Study of Social Change, Mumbai, India (RDP, SAS, MG, HS, MD, SJ, AL, HC, DS, PC-G, PM-L, and GS); the Medical Research Council Lifecourse Epidemiology Unit (SHK, NB, PJC, EM-Z, AKW, VAC, DJPB, and CHDF), the National Institute for Health Research Southampton Biomedical Research Centre (AAJ), and Public Health Nutrition, Faculty of Medicine (BMM), University of Southampton, Southampton, United Kingdom; and Streehitakarini, Mumbai, India (VT).
authors.forename: Priyadarshini
authors.initials: P
authors.lastname: Muley-Lotankar
authors.affiliation: From the Centre for the Study of Social Change, Mumbai, India (RDP, SAS, MG, HS, MD, SJ, AL, HC, DS, PC-G, PM-L, and GS); the Medical Research Council Lifecourse Epidemiology Unit (SHK, NB, PJC, EM-Z, AKW, VAC, DJPB, and CHDF), the National Institute for Health Research Southampton Biomedical Research Centre (AAJ), and Public Health Nutrition, Faculty of Medicine (BMM), University of Southampton, Southampton, United Kingdom; and Streehitakarini, Mumbai, India (VT).
authors.forename: G
authors.initials: G
authors.lastname: Subbulakshmi
authors.affiliation: From the Centre for the Study of Social Change, Mumbai, India (RDP, SAS, MG, HS, MD, SJ, AL, HC, DS, PC-G, PM-L, and GS); the Medical Research Council Lifecourse Epidemiology Unit (SHK, NB, PJC, EM-Z, AKW, VAC, DJPB, and CHDF), the National Institute for Health Research Southampton Biomedical Research Centre (AAJ), and Public Health Nutrition, Faculty of Medicine (BMM), University of Southampton, Southampton, United Kingdom; and Streehitakarini, Mumbai, India (VT).
authors.forename: Andrew K
authors.initials: AK
authors.lastname: Wills
authors.affiliation: From the Centre for the Study of Social Change, Mumbai, India (RDP, SAS, MG, HS, MD, SJ, AL, HC, DS, PC-G, PM-L, and GS); the Medical Research Council Lifecourse Epidemiology Unit (SHK, NB, PJC, EM-Z, AKW, VAC, DJPB, and CHDF), the National Institute for Health Research Southampton Biomedical Research Centre (AAJ), and Public Health Nutrition, Faculty of Medicine (BMM), University of Southampton, Southampton, United Kingdom; and Streehitakarini, Mumbai, India (VT).
authors.forename: Vanessa A
authors.initials: VA
authors.lastname: Cox
authors.affiliation: From the Centre for the Study of Social Change, Mumbai, India (RDP, SAS, MG, HS, MD, SJ, AL, HC, DS, PC-G, PM-L, and GS); the Medical Research Council Lifecourse Epidemiology Unit (SHK, NB, PJC, EM-Z, AKW, VAC, DJPB, and CHDF), the National Institute for Health Research Southampton Biomedical Research Centre (AAJ), and Public Health Nutrition, Faculty of Medicine (BMM), University of Southampton, Southampton, United Kingdom; and Streehitakarini, Mumbai, India (VT).
authors.forename: Vijaya
authors.initials: V
authors.lastname: Taskar
authors.affiliation: From the Centre for the Study of Social Change, Mumbai, India (RDP, SAS, MG, HS, MD, SJ, AL, HC, DS, PC-G, PM-L, and GS); the Medical Research Council Lifecourse Epidemiology Unit (SHK, NB, PJC, EM-Z, AKW, VAC, DJPB, and CHDF), the National Institute for Health Research Southampton Biomedical Research Centre (AAJ), and Public Health Nutrition, Faculty of Medicine (BMM), University of Southampton, Southampton, United Kingdom; and Streehitakarini, Mumbai, India (VT).
authors.forename: David J P
authors.initials: DJ
authors.lastname: Barker
authors.affiliation: From the Centre for the Study of Social Change, Mumbai, India (RDP, SAS, MG, HS, MD, SJ, AL, HC, DS, PC-G, PM-L, and GS); the Medical Research Council Lifecourse Epidemiology Unit (SHK, NB, PJC, EM-Z, AKW, VAC, DJPB, and CHDF), the National Institute for Health Research Southampton Biomedical Research Centre (AAJ), and Public Health Nutrition, Faculty of Medicine (BMM), University of Southampton, Southampton, United Kingdom; and Streehitakarini, Mumbai, India (VT).
authors.forename: Alan A
authors.initials: AA
authors.lastname: Jackson
authors.affiliation: From the Centre for the Study of Social Change, Mumbai, India (RDP, SAS, MG, HS, MD, SJ, AL, HC, DS, PC-G, PM-L, and GS); the Medical Research Council Lifecourse Epidemiology Unit (SHK, NB, PJC, EM-Z, AKW, VAC, DJPB, and CHDF), the National Institute for Health Research Southampton Biomedical Research Centre (AAJ), and Public Health Nutrition, Faculty of Medicine (BMM), University of Southampton, Southampton, United Kingdom; and Streehitakarini, Mumbai, India (VT).
authors.forename: Barrie M
authors.initials: BM
authors.lastname: Margetts
authors.affiliation: From the Centre for the Study of Social Change, Mumbai, India (RDP, SAS, MG, HS, MD, SJ, AL, HC, DS, PC-G, PM-L, and GS); the Medical Research Council Lifecourse Epidemiology Unit (SHK, NB, PJC, EM-Z, AKW, VAC, DJPB, and CHDF), the National Institute for Health Research Southampton Biomedical Research Centre (AAJ), and Public Health Nutrition, Faculty of Medicine (BMM), University of Southampton, Southampton, United Kingdom; and Streehitakarini, Mumbai, India (VT).
authors.forename: Caroline H D
authors.initials: CH
authors.lastname: Fall
mesh_terms: D000328:Adult; D001724:Birth Weight; D015992:Body Mass Index; D004032:Diet; D019587:Dietary Supplements; D002149:Energy Intake; D005260:Female; D005492:Folic Acid / Q000008:administration & dosage; D005638:Fruit; D005865:Gestational Age; D006293:Health Promotion; D006801:Humans; D007194:India; D007230:Infant, Low Birth Weight; D007231:Infant, Newborn; D039382:Maternal Nutritional Physiological Phenomena; D018977:Micronutrients / Q000008:administration & dosage; D010349:Patient Compliance; D011247:Pregnancy; D012256:Riboflavin / Q000008:administration & dosage; D012959:Socioeconomic Factors; D014675:Vegetables; D014805:Vitamin B 12 / Q000008:administration & dosage; D055815:Young Adult; D019207:beta Carotene / Q000008:administration & dosage
chemical_list: D018977:Micronutrients; D019207:beta Carotene; D005492:Folic Acid; D014805:Vitamin B 12; D012256:Riboflavin