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
  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.
  
  
  CONCLUSIONS
  Positive results of this trial will support a paradigm shift in attention to nutrition of all females of child-bearing age.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01883193.
authors.affiliation: University of Colorado Denver, Aurora, CO, USA. Michael.Hambidge@ucdenver.edu.
authors.forename: K Michael
authors.initials: KM
authors.lastname: Hambidge
authors.forename: Nancy F
authors.initials: NF
authors.lastname: Krebs
authors.forename: Jamie E
authors.initials: JE
authors.lastname: Westcott
authors.forename: Ana
authors.initials: A
authors.lastname: Garces
authors.forename: Shivaprasad S
authors.initials: SS
authors.lastname: Goudar
authors.forename: Balachandra S
authors.initials: BS
authors.lastname: Kodkany
authors.forename: Omrana
authors.initials: O
authors.lastname: Pasha
authors.forename: Antoinette
authors.initials: A
authors.lastname: Tshefu
authors.forename: Carl L
authors.initials: CL
authors.lastname: Bose
authors.forename: Lester
authors.initials: L
authors.lastname: Figueroa
authors.forename: Robert L
authors.initials: RL
authors.lastname: Goldenberg
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Derman
authors.forename: Jacob E
authors.initials: JE
authors.lastname: Friedman
authors.forename: Daniel N
authors.initials: DN
authors.lastname: Frank
authors.forename: Elizabeth M
authors.initials: EM
authors.lastname: McClure
authors.forename: Kristen
authors.initials: K
authors.lastname: Stolka
authors.forename: Abhik
authors.initials: A
authors.lastname: Das
authors.forename: Marion
authors.initials: M
authors.lastname: Koso-Thomas
authors.forename: Shelly
authors.initials: S
authors.lastname: Sundberg
mesh_terms: D000293:Adolescent; D000328:Adult; D001835:Body Weight; D015023:Democratic Republic of the Congo; D005260:Female; D005500:Follow-Up Studies; D005865:Gestational Age; D006801:Humans; D008429:Maternal Welfare; D015596:Nutrition Assessment; D009752:Nutritional Status; D010154:Pakistan; D016742:Preconception Care / Q000379:methods*; D011247:Pregnancy; D011295:Prenatal Care / Q000379:methods*; D039401:Prenatal Nutritional Physiological Phenomena; D012189:Retrospective Studies; D055815:Young Adult