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BMC Pregnancy and Childbirth
Published in: BMC Pregnancy and Childbirth 1/2014

Open Access 01-12-2014 | Study protocol

Preconception maternal nutrition: a multi-site randomized controlled trial

Authors: K Michael Hambidge, Nancy F Krebs, Jamie E Westcott, Ana Garces, Shivaprasad S Goudar, Balachandra S Kodkany, Omrana Pasha, Antoinette Tshefu, Carl L Bose, Lester Figueroa, Robert L Goldenberg, Richard J Derman, Jacob E Friedman, Daniel N Frank, Elizabeth M McClure, Kristen Stolka, Abhik Das, Marion Koso-Thomas, Shelly Sundberg, the Preconception Trial Group

Published in: BMC Pregnancy and Childbirth | Issue 1/2014

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Abstract

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.
Appendix
Available only for authorised users
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Metadata
Title
Preconception maternal nutrition: a multi-site randomized controlled trial
Authors
K Michael Hambidge
Nancy F Krebs
Jamie E Westcott
Ana Garces
Shivaprasad S Goudar
Balachandra S Kodkany
Omrana Pasha
Antoinette Tshefu
Carl L Bose
Lester Figueroa
Robert L Goldenberg
Richard J Derman
Jacob E Friedman
Daniel N Frank
Elizabeth M McClure
Kristen Stolka
Abhik Das
Marion Koso-Thomas
Shelly Sundberg
the Preconception Trial Group
Publication date
01-12-2014
Publisher
BioMed Central
Published in
BMC Pregnancy and Childbirth / Issue 1/2014
Electronic ISSN: 1471-2393
DOI
https://doi.org/10.1186/1471-2393-14-111

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