TY - JOUR
T1 - Preconception maternal nutrition
T2 - A multi-site randomized controlled trial
AU - Hambidge, K. M.
AU - Krebs, Nancy F.
AU - Westcott, Jamie E.
AU - Garces, Ana
AU - Goudar, Shivaprasad S.
AU - Kodkany, Balachandra S.
AU - Pasha, Omrana
AU - Tshefu, Antoinette
AU - Bose, Carl L.
AU - Figueroa, Lester
AU - Goldenberg, Robert L.
AU - Derman, Richard J.
AU - Friedman, Jacob E.
AU - Frank, Daniel N.
AU - McClure, Elizabeth M.
AU - Stolka, Kristen
AU - Das, Abhik
AU - Koso-Thomas, Marion
AU - Sundberg, Shelly
N1 - Funding Information:
Supported by the Bill & Melinda Gates Foundation OPP1055867. Also supported by The Eunice Kennedy Shriver National Institute of Child Health & Human Development and the Office of Dietary Supplements, NIH #U10 HD076474.
PY - 2014/3/20
Y1 - 2014/3/20
N2 - Background: Research directed to optimizing maternal nutrition commencing prior to conception remains very limited, despite suggestive evidence of its importance in addition to ensuring an optimal nutrition environment in the periconceptional period and throughout the first trimester of pregnancy.Methods/Study design: This is an individually randomized controlled trial of the impact on birth length (primary outcome) of the time at which a maternal nutrition intervention is commenced: Arm 1: ≥ 3 mo preconception vs. Arm 2: 12-14 wk gestation vs. Arm 3: none.192 (derived from 480) randomized mothers and living offspring in each arm in each of four research sites (Guatemala, India, Pakistan, Democratic Republic of the Congo). The intervention is a daily 20 g lipid-based (118 kcal) multi-micronutient (MMN) supplement. Women randomized to receive this intervention with body mass index (BMI) <20 or whose gestational weight gain is low will receive an additional 300 kcal/d as a balanced energy-protein supplement. Researchers will visit homes biweekly to deliver intervention and monitor compliance, pregnancy status and morbidity; ensure prenatal and delivery care; and promote breast feeding. The primary outcome is birth length. Secondary outcomes include: fetal length at 12 and 34 wk; incidence of low birth weight (LBW); neonatal/infant anthropometry 0-6 mo of age infectious disease morbidity; maternal, fetal, newborn, and infant epigenetics; maternal and infant nutritional status; maternal and infant microbiome; gut inflammatory biomarkers and bioactive and nutritive compounds in breast milk. The primary analysis will compare birth Length-for-Age Z-score (LAZ) among trial arms (independently for each site, estimated effect size: 0.35). Additional statistical analyses will examine the secondary outcomes and a pooled analysis of data from all sites.Discussion: Positive results of this trial will support a paradigm shift in attention to nutrition of all females of child-bearing age.Trial registration: ClinicalTrials.gov NCT01883193.
AB - Background: Research directed to optimizing maternal nutrition commencing prior to conception remains very limited, despite suggestive evidence of its importance in addition to ensuring an optimal nutrition environment in the periconceptional period and throughout the first trimester of pregnancy.Methods/Study design: This is an individually randomized controlled trial of the impact on birth length (primary outcome) of the time at which a maternal nutrition intervention is commenced: Arm 1: ≥ 3 mo preconception vs. Arm 2: 12-14 wk gestation vs. Arm 3: none.192 (derived from 480) randomized mothers and living offspring in each arm in each of four research sites (Guatemala, India, Pakistan, Democratic Republic of the Congo). The intervention is a daily 20 g lipid-based (118 kcal) multi-micronutient (MMN) supplement. Women randomized to receive this intervention with body mass index (BMI) <20 or whose gestational weight gain is low will receive an additional 300 kcal/d as a balanced energy-protein supplement. Researchers will visit homes biweekly to deliver intervention and monitor compliance, pregnancy status and morbidity; ensure prenatal and delivery care; and promote breast feeding. The primary outcome is birth length. Secondary outcomes include: fetal length at 12 and 34 wk; incidence of low birth weight (LBW); neonatal/infant anthropometry 0-6 mo of age infectious disease morbidity; maternal, fetal, newborn, and infant epigenetics; maternal and infant nutritional status; maternal and infant microbiome; gut inflammatory biomarkers and bioactive and nutritive compounds in breast milk. The primary analysis will compare birth Length-for-Age Z-score (LAZ) among trial arms (independently for each site, estimated effect size: 0.35). Additional statistical analyses will examine the secondary outcomes and a pooled analysis of data from all sites.Discussion: Positive results of this trial will support a paradigm shift in attention to nutrition of all females of child-bearing age.Trial registration: ClinicalTrials.gov NCT01883193.
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U2 - 10.1186/1471-2393-14-111
DO - 10.1186/1471-2393-14-111
M3 - Article
C2 - 24650219
AN - SCOPUS:84901997537
SN - 1471-2393
VL - 14
JO - BMC Pregnancy and Childbirth
JF - BMC Pregnancy and Childbirth
IS - 1
M1 - 111
ER -