Preconception maternal nutrition: A multi-site randomized controlled trial

K. M. 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

doi:10.1186/1471-2393-14-111

Preconception maternal nutrition: A multi-site randomized controlled trial

K. M. 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

Research output: Contribution to journal › Article › peer-review

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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.

Original language	English (US)
Article number	111
Journal	BMC pregnancy and childbirth
Volume	14
Issue number	1
DOIs	https://doi.org/10.1186/1471-2393-14-111
State	Published - Mar 20 2014
Externally published	Yes

Keywords

Birth length
Epigenetics
Maternal
Microbiome
Nutrition
Preconception

ASJC Scopus subject areas

Obstetrics and Gynecology

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10.1186/1471-2393-14-111

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Hambidge, K. M., Krebs, N. F., Westcott, J. E., Garces, A., Goudar, S. S., Kodkany, B. S., Pasha, O., Tshefu, A., Bose, C. L., Figueroa, L., Goldenberg, R. L., Derman, R. J., Friedman, J. E., Frank, D. N., McClure, E. M., Stolka, K., Das, A., Koso-Thomas, M., & Sundberg, S. (2014). Preconception maternal nutrition: A multi-site randomized controlled trial. BMC pregnancy and childbirth, 14(1), Article 111. https://doi.org/10.1186/1471-2393-14-111

Hambidge, KM, Krebs, NF, Westcott, JE, Garces, A, Goudar, SS, Kodkany, BS, Pasha, O, Tshefu, A, Bose, CL, Figueroa, L, Goldenberg, RL, Derman, RJ, Friedman, JE, Frank, DN, McClure, EM, Stolka, K, Das, A, Koso-Thomas, M & Sundberg, S 2014, 'Preconception maternal nutrition: A multi-site randomized controlled trial', BMC pregnancy and childbirth, vol. 14, no. 1, 111. https://doi.org/10.1186/1471-2393-14-111

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title = "Preconception maternal nutrition: A multi-site randomized controlled trial",

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.",

keywords = "Birth length, Epigenetics, Maternal, Microbiome, Nutrition, Preconception",

author = "Hambidge, {K. M.} and Krebs, {Nancy F.} and Westcott, {Jamie E.} and Ana Garces and Goudar, {Shivaprasad S.} and Kodkany, {Balachandra S.} and Omrana Pasha and Antoinette Tshefu and Bose, {Carl L.} and Lester Figueroa and Goldenberg, {Robert L.} and Derman, {Richard J.} and Friedman, {Jacob E.} and Frank, {Daniel N.} and McClure, {Elizabeth M.} and Kristen Stolka and Abhik Das and Marion Koso-Thomas and Shelly Sundberg",

note = "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.",

year = "2014",

month = mar,

day = "20",

doi = "10.1186/1471-2393-14-111",

language = "English (US)",

volume = "14",

journal = "BMC pregnancy and childbirth",

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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.

KW - Birth length

KW - Epigenetics

KW - Maternal

KW - Microbiome

KW - Nutrition

KW - Preconception

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Preconception maternal nutrition: A multi-site randomized controlled trial

Abstract

Keywords

ASJC Scopus subject areas

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