Clinical trial NCT01883193: Women First: Preconception Maternal Nutrition
Official title: Women First: Preconception Maternal Nutrition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Instituto de Nutricion de Centroamerica y Panama (INCAP)
name: Kinshasa School of Public Health
name: Jawaharlal Nehru Medical College
name: Aga Khan University
name: RTI International
First posted: 2013-06-21
Enrollment: 7374
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: The objective is to determine the benefits to the offspring of women in poor, food-insecure environments of commencing a daily comprehensive maternal nutrition supplement (with additional balanced calorie/protein supplement for underweight participants) ≥ 3 months prior to conception versus the benefits of commencing the same supplement at 12 weeks gestation and also to compare offspring outcomes with those of a control group which receives no supplement.

Eligibility criteria: Inclusion Criteria:

* 16-35 years of age;
* expectation to have first or further pregnancy without intent to utilize contraception
* Hb \>8 g/dL

Exclusion Criteria:

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

Primary outcomes:
measure: Neonatal linear growth
timeFrame: <24 hours of age
Secondary outcomes:
measure: Length-for-age Z-scores
timeFrame: age 0.5, 1, 3, 6, 12, 18 and 24 months postnatal
measure: Estimate fetal growth
timeFrame: 12 weeks gestation
measure: Mean birth weight
timeFrame: at birth
measure: Incidence of low birth weight (LBW) infants
timeFrame: at birth
measure: Perinatal Mortality
timeFrame: From 20 weeks gestation through 1 month of age
measure: Incidence of severe neonatal and infant infectious disease
timeFrame: birth to 6 months of age
measure: Epigenome (Maternal)
timeFrame: baseline, 12 and 34 weeks gestation, delivery, and 3 months postpartum (maternal); 2 weeks and 3 months of age (infant)
measure: Epigenome (Infant)
timeFrame: 2 weeks and 3 months of age
measure: Deep phenotyping of maternal metabolic and nutritional status
timeFrame: 12 and 34 weeks gestation, delivery, and 3 months postpartum
measure: Microbiome (maternal)
timeFrame: 12 & 34 weeks gestation and delivery (maternal)
measure: Microbiome (infant)
timeFrame: 14 days and 3 months of age (infant)
measure: Composition of breast milk
timeFrame: 14 days postpartum
measure: Neurodevelopment assessment
timeFrame: 24 mo age
measure: Gestational weight gain (GWG)
timeFrame: Enrollment to delivery
Other outcomes:
Locations:
city: Kinshasa
country: Congo, The Democratic Republic of the
facility: Kinshasa School of Public Health
city: Guatemala City
country: Guatemala
facility: INCAP
city: Belgaum
country: India
facility: Jawaharlal Nehru Medical College
city: Karachi
country: Pakistan
facility: Aga Khan University
Study officials:
affiliation: University of Colorado, Denver
name: Nancy Krebs, MD,MS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado, Denver
name: Michael Hambidge, MD, SciD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.