Women First: Preconception Maternal Nutrition

NCT01883193 | Completed DMC

• 3 other identifiers: 12-1672OPP1055867U10HD076474-01
• Study Type: interventional
• Target: 7,374
• Locations: 4 countries
• Sites: 4

Brief Summary

Multi-country three-arm, individually randomized, non-masked, controlled trial to ascertain the benefits of ensuring optimal maternal nutrition before conception and providing an evidence base for programmatic priority directed to minimizing the risk of malnutrition in all females of reproductive age.

Conditions

Maternal Malnutrition; Growth Failure; Mortality; Morbidity; Stunting

Keywords

preconception maternal nutrition; LBW; Length-for-age; maternal nutrition supplement; multi-micronutrient fortified lipid-based supplement; infant growth; low-resource settings

Outcome Measures

Primary Outcomes (1)

• Neonatal linear growth

  Research assistants will obtain neonatal length measurement at \<24 hours of age.

  <24 hours of age

Secondary Outcomes (14)

• Length-for-age Z-scores

  age 0.5, 1, 3, 6, 12, 18 and 24 months postnatal

• Estimate fetal growth

  12 weeks gestation

• Mean birth weight

  at birth

• Incidence of low birth weight (LBW) infants

  at birth

• Perinatal Mortality

  From 20 weeks gestation through 1 month of age

Study Arms (3)

Arm 1: Preconception

EXPERIMENTAL

Arm 1 will commence the comprehensive maternal nutrition intervention at 3-7 months postpartum. Delivery of the intervention will be monitored biweekly by collection of empty and unused sachets of the lipid-based supplement (LNS), maternal report, and casual observation of household behavior. Arm 1 participants will be weighed monthly and Body Mass Index (BMI) calculated. If BMI \<20 an additional energy supplement will be provided. Menstrual history will be obtained at each visit and a urine pregnancy test will be performed if menses is delayed.

Dietary Supplement: Comprehensive Maternal Nutrition Intervention

Arm 2: Pregnancy

EXPERIMENTAL

Participants in Arm 2 will commence the same comprehensive maternal nutrition intervention at 12 weeks gestation.

Dietary Supplement: Comprehensive Maternal Nutrition Intervention

Arm 3: Control

NO INTERVENTION

Participants in Arm 3 will receive biweekly visits to monitor pregnancy status. No health advice will be given other than information about prenatal care, location of delivery, and breastfeeding education in the third trimester.

Interventions

Comprehensive Maternal Nutrition Intervention DIETARY_SUPPLEMENT

The nutrition intervention will be delivered before conception or at 12 weeks gestation and continued through delivery and compared with a control group. The supplement to be used is a multi-micronutrient (MMN) fortified lipid-based supplement composed of dried skimmed milk, soybean and peanut extract, sugar, maltodextrin stabilizers, and emulsifiers.

Also known as: multi micronutrient (MMN) fortified lipid-based supplement, lipid-based nutrient supplement, LNS

Arm 1: Preconception; Arm 2: Pregnancy

Eligibility Criteria

• Age: 16 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• years of age;
• expectation to have first or further pregnancy without intent to utilize contraception
• Hb \>8 g/dL

You may not qualify if:

• Nulliparous women who do not agree to hospital delivery (equipped for caesarian section) or/and do not have ready access to such a facility.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Instituto de Nutricion de Centroamerica y Panama (INCAP): collaborator
• Kinshasa School of Public Health: collaborator
• Jawaharlal Nehru Medical College: collaborator
• Aga Khan University: collaborator
• RTI International: collaborator

Study Sites (4)

Kinshasa School of Public Health

Kinshasa, Democratic Republic of the Congo

Location

INCAP

Guatemala City, Guatemala

Location

Jawaharlal Nehru Medical College

Belagavi, 590 010, India

Location

Aga Khan University

Karachi, Pakistan

Location

Related Publications (22)

• 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; Preconception Trial Group. Preconception maternal nutrition: a multi-site randomized controlled trial. BMC Pregnancy Childbirth. 2014 Mar 20;14:111. doi: 10.1186/1471-2393-14-111.

  PMID: 24650219 BACKGROUND

• Hambidge KM, Westcott JE, Garces A, Figueroa L, Goudar SS, Dhaded SM, Pasha O, Ali SA, Tshefu A, Lokangaka A, Derman RJ, Goldenberg RL, Bose CL, Bauserman M, Koso-Thomas M, Thorsten VR, Sridhar A, Stolka K, Das A, McClure EM, Krebs NF; Women First Preconception Trial Study Group. A multicountry randomized controlled trial of comprehensive maternal nutrition supplementation initiated before conception: the Women First trial. Am J Clin Nutr. 2019 Feb 1;109(2):457-469. doi: 10.1093/ajcn/nqy228.

  PMID: 30721941 BACKGROUND

• Hambidge KM, Bann CM, McClure EM, Westcott JE, Garces A, Figueroa L, Goudar SS, Dhaded SM, Pasha O, Ali SA, Derman RJ, Goldenberg RL, Koso-Thomas M, Somannavar MS, Herekar V, Khan U, Krebs NF. Maternal Characteristics Affect Fetal Growth Response in the Women First Preconception Nutrition Trial. Nutrients. 2019 Oct 21;11(10):2534. doi: 10.3390/nu11102534.

  PMID: 31640153 BACKGROUND

• Gilley SP, Weaver NE, Sticca EL, Jambal P, Palacios A, Kerns ME, Anand P, Kemp JF, Westcott JE, Figueroa L, Garces AL, Ali SA, Pasha O, Saleem S, Hambidge KM, Hendricks AE, Krebs NF, Borengasser SJ. Longitudinal Changes of One-Carbon Metabolites and Amino Acid Concentrations during Pregnancy in the Women First Maternal Nutrition Trial. Curr Dev Nutr. 2019 Nov 18;4(1):nzz132. doi: 10.1093/cdn/nzz132. eCollection 2020 Jan.

  PMID: 32175519 BACKGROUND

• Lander RL, Hambidge KM, Westcott JE, Tejeda G, Diba TS, Mastiholi SC, Khan US, Garces A, Figueroa L, Tshefu A, Lokangaka A, Goudar SS, Somannavar MS, Ali SA, Saleem S, McClure EM, Krebs NF, Group OBOTWFPNT. Pregnant Women in Four Low-Middle Income Countries Have a High Prevalence of Inadequate Dietary Intakes That Are Improved by Dietary Diversity. Nutrients. 2019 Jul 10;11(7):1560. doi: 10.3390/nu11071560.

  PMID: 31295916 BACKGROUND

• Krebs NF, Hambidge KM. Response to Editorial: Balancing the benefits of maternal nutritional interventions; time to put women first! Am J Clin Nutr. 2019 Aug 1;110(2):521-522. doi: 10.1093/ajcn/nqz077. No abstract available.

  PMID: 31367762 BACKGROUND

• Borengasser SJ, Baker PR 2nd, Kerns ME, Miller LV, Palacios AP, Kemp JF, Westcott JE, Morrison SD, Hernandez TL, Garces A, Figueroa L, Friedman JE, Hambidge KM, Krebs NF. Preconception Micronutrient Supplementation Reduced Circulating Branched Chain Amino Acids at 12 Weeks Gestation in an Open Trial of Guatemalan Women Who Are Overweight or Obese. Nutrients. 2018 Sep 11;10(9):1282. doi: 10.3390/nu10091282.

  PMID: 30208589 BACKGROUND

• Aziz Ali S, Abbasi Z, Feroz A, Hambidge KM, Krebs NF, Westcott JE, Saleem S. Factors associated with anemia among women of the reproductive age group in Thatta district: study protocol. Reprod Health. 2019 Mar 18;16(1):34. doi: 10.1186/s12978-019-0688-7.

  PMID: 30885226 BACKGROUND

• Tang M, Frank DN, Tshefu A, Lokangaka A, Goudar SS, Dhaded SM, Somannavar MS, Hendricks AE, Ir D, Robertson CE, Kemp JF, Lander RL, Westcott JE, Hambidge KM, Krebs NF. Different Gut Microbial Profiles in Sub-Saharan African and South Asian Women of Childbearing Age Are Primarily Associated With Dietary Intakes. Front Microbiol. 2019 Aug 14;10:1848. doi: 10.3389/fmicb.2019.01848. eCollection 2019.

  PMID: 31474951 BACKGROUND

• Ali SA, Khan U, Abrejo F, Saleem S, Hambidge MK, Krebs NF, Westcott JE, Goldenberg RL, McClure EM, Pasha O. Challenges of Implementing an Individual Randomized Controlled Trial (Women First: Preconception Maternal Nutrition Study) in a Rural Study Site: A Case Study From Pakistan. Nutr Metab Insights. 2019 Jul 4;21:1178638819852059. doi: 10.1177/1178638819852059. eCollection 2019.

  PMID: 31320804 BACKGROUND

• Dhaded SM, Hambidge KM, Ali SA, Somannavar M, Saleem S, Pasha O, Khan U, Herekar V, Vernekar S, Kumar S Y, Westcott JE, Thorsten VR, Sridhar A, Das A, McClure E, Derman RJ, Goldenberg RL, Koso-Thomas M, Goudar SS, Krebs NF. Preconception nutrition intervention improved birth length and reduced stunting and wasting in newborns in South Asia: The Women First Randomized Controlled Trial. PLoS One. 2020 Jan 29;15(1):e0218960. doi: 10.1371/journal.pone.0218960. eCollection 2020.

  PMID: 31995570 BACKGROUND

• Hambidge KM, Krebs NF, Garces A, Westcott JE, Figueroa L, Goudar SS, Dhaded S, Pasha O, Aziz Ali S, Tshefu A, Lokangaka A, Thorsten VR, Das A, Stolka K, McClure EM, Lander RL, Bose CL, Derman RJ, Goldenberg RL, Bauserman M. Anthropometric indices for non-pregnant women of childbearing age differ widely among four low-middle income populations. BMC Public Health. 2017 Jul 24;18(1):45. doi: 10.1186/s12889-017-4509-z.

  PMID: 28738791 BACKGROUND

• Lander RL, Hambidge KM, Krebs NF, Westcott JE, Garces A, Figueroa L, Tejeda G, Lokangaka A, Diba TS, Somannavar MS, Honnayya R, Ali SA, Khan US, McClure EM, Thorsten VR, Stolka KB; Women First Preconception Nutrition Trial Group. Repeat 24-hour recalls and locally developed food composition databases: a feasible method to estimate dietary adequacy in a multi-site preconception maternal nutrition RCT. Food Nutr Res. 2017 Apr 11;61(1):1311185. doi: 10.1080/16546628.2017.1311185. eCollection 2017.

  PMID: 28469549 BACKGROUND

• Krebs NF, Hambidge KM, Westcott JL, Garces AL, Figueroa L, Tsefu AK, Lokangaka AL, Goudar SS, Dhaded SM, Saleem S, Ali SA, Bose CL, Derman RJ, Goldenberg RL, Thorsten VR, Sridhar A, Chowdhury D, Das A; Women First Preconception Maternal Nutrition Study Group. Growth from Birth Through Six Months for Infants of Mothers in the "Women First" Preconception Maternal Nutrition Trial. J Pediatr. 2021 Feb;229:199-206.e4. doi: 10.1016/j.jpeds.2020.09.032. Epub 2020 Sep 18.

  PMID: 32956698 BACKGROUND

• Ali SA, Abbasi Z, Shahid B, Moin G, Hambidge KM, Krebs NF, Westcott JE, McClure EM, Goldenberg RL, Saleem S. Prevalence and determinants of anemia among women of reproductive age in Thatta Pakistan: Findings from a cross-sectional study. PLoS One. 2020 Sep 24;15(9):e0239320. doi: 10.1371/journal.pone.0239320. eCollection 2020.

  PMID: 32970719 BACKGROUND

• Aziz Ali S, Khan U, Abrejo F, Vollmer B, Saleem S, Hambidge KM, Krebs NF, Westcott JE, Goldenberg RL, McClure EM, Pasha O. Use of Smokeless Tobacco Before Conception and Its Relationship With Maternal and Fetal Outcomes of Pregnancy in Thatta, Pakistan: Findings From Women First Study. Nicotine Tob Res. 2021 Aug 4;23(8):1291-1299. doi: 10.1093/ntr/ntaa215.

  PMID: 33084903 BACKGROUND

• Gilley SP, Westcott JL, Kemp JF, Long JM, Hambidge KM, Shankar K, Krebs NF; Women First Trial Group. A Multicountry Analysis of Maternal Selenium Status in Pregnancy and Lactation and Infant Birth Outcomes: Findings from the Women First Maternal Preconception Study. J Nutr. 2025 Dec 27:101279. doi: 10.1016/j.tjnut.2025.101279. Online ahead of print.

  PMID: 41461273 DERIVED

• Ali SA, Valeri L, Kahe K, Genkinger JM, Saleem S, Jessani S, Goldenberg RL, Westcott JE, Kemp JF, Garces AL, Figueroa L, Goudar SS, Dhaded SM, Derman RJ, Tshefu A, Lokangaka AL, Bauserman MS, McClure EM, Koso Thomas M, Kuhn L, Krebs NF; Women First Preconception Nutrition Trial Group. Hemoglobin During Pregnancy Does Not Mediate the Relationship between Nutrition Supplements and Intrauterine Growth: A Secondary Data Analysis of Women First Preconception Nutrition Trial. J Nutr. 2025 Jul;155(7):2385-2397. doi: 10.1016/j.tjnut.2025.04.036. Epub 2025 May 19.

  PMID: 40339908 DERIVED

• Kemp JF, Hambidge KM, Westcott JL, Ali SA, Saleem S, Garces A, Figueroa L, Somannavar MS, Goudar SS, Long JM, Hendricks AE, Krebs NF; Women First Preconception Maternal Nutrition Trial Group. Zinc Supplementation Initiated Prior to or During Pregnancy Modestly Impacted Maternal Status and High Prevalence of Hypozincemia in Pregnancy and Lactation: The Women First Preconception Maternal Nutrition Trial. J Nutr. 2024 Jun;154(6):1917-1926. doi: 10.1016/j.tjnut.2024.04.018. Epub 2024 Apr 16.

  PMID: 38621624 DERIVED

• Fernandes M, Krebs NF, Westcott J, Tshefu A, Lokangaka A, Bauserman M, Garces AL, Figueroa L, Saleem S, Aziz SA, Goldenberg RL, Goudar SS, Dhaded SM, Derman RJ, Kemp JF, Koso-Thomas M, Sridhar A, M McClure E, Hambidge KM; Women First Preconception Nutrition Trial Study Group. Neurodevelopment, vision and auditory outcomes at age 2 years in offspring of participants in the 'Women First' maternal preconception nutrition randomised controlled trial. Arch Dis Child. 2023 Aug;108(8):622-631. doi: 10.1136/archdischild-2023-325352. Epub 2023 May 4.

  PMID: 37142335 DERIVED

• Krebs NF, Hambidge KM, Westcott JL, Garces AL, Figueroa L, Tshefu AK, Lokangaka AL, Goudar SS, Dhaded SM, Saleem S, Ali SA, Bauserman MS, Derman RJ, Goldenberg RL, Das A, Chowdhury D; Women First Preconception Maternal Nutrition Study Group. Birth length is the strongest predictor of linear growth status and stunting in the first 2 years of life after a preconception maternal nutrition intervention: the children of the Women First trial. Am J Clin Nutr. 2022 Jul 6;116(1):86-96. doi: 10.1093/ajcn/nqac051.

  PMID: 35681255 DERIVED

• Castillo-Castrejon M, Yang IV, Davidson EJ, Borengasser SJ, Jambal P, Westcott J, Kemp JF, Garces A, Ali SA, Saleem S, Goldenberg RL, Figueroa L, Hambidge KM, Krebs NF, Powell TL. Preconceptional Lipid-Based Nutrient Supplementation in 2 Low-Resource Countries Results in Distinctly Different IGF-1/mTOR Placental Responses. J Nutr. 2021 Mar 11;151(3):556-569. doi: 10.1093/jn/nxaa354.

  PMID: 33382407 DERIVED

MeSH Terms

Conditions

Failure to Thrive; Growth Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Nancy Krebs, MD,MS

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

• Michael Hambidge, MD, SciD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2013
• First Posted: June 21, 2013
• Study Start: August 1, 2013
• Primary Completion: March 30, 2017
• Study Completion: March 30, 2019
• Last Updated: July 8, 2021

Record last verified: 2021-07

Locations

GU (1); PA (1); IN (1); DE (1)