Broad Goal: To participate in all collaborative activities relevant to the mission of the Global Network including the development and leadership of Common Network projects as exemplified by Preconception Maternal Nutrition. Study Objective: Determine the public health benefits in resource-poor populations of providing a comprehensive nutrition supplement to women of reproductive age commencing S3 mo. prior to conception (Arm 1, PC) in comparison with starting the same supplement at 12 wk. gestation (Arm 2, PG) or provision of iron/folate alone (Arm 3, IPS). Primary outcomes: (1) length-for-age Z-score (LAZ) at 7 d postpartum;(2) LAZ at 6 mo. of age. Secondary outcomes include: comparing arms for fetal length;birth weight;incidence of low birth weight;incidence of perinata and early infancy (<6 mo.) mortality and severe infectious disease morbidity. Research Design &Methods: Multi-site randomized controlled efficacy trial. Each arm will include 800 women divided equally among sites. The first 100 of each arm in each site to conceive continue interventions <6 mo. postpartum. Inclusion criteria: para 1-2, <26 yr., enrolled through Global Network Maternal Neonatal Health Registry (MNHR);algorithms based on MNHR data to enroll at 12 ? 3 mo. post-partum. Arm 1 commences intervention at enrollment;Arms 2 and 3 receive IPS from enrollment with Arm 2 switching to same supplement as Arm 1 at 12 weeks gestation. Intervention provides 100 kcal/d as a lipid-based multi-micronutrient (MMN) product, with increasing energy to 500 kcal/d and protein to 25g/d if BMI <20 or pregnancy weight gain is low. Baseline parental, fetal (ultrasound), birth weight, early neonatal (7 d) and infant anthropometry (3 and 6 mo.);longitudinal maternal blood, subsample cord blood &placenta samples will be collected by trained Network and Health personnel. Mortality and morbidity data will be collected from MNHR. The primary analyses will compare LAZ at 7 days for Arm 1 vs. Arms 2 and 3 controlling for site. The results of this study have potentially profound implications for the impat of nutrition interventions initiated prior to conception, and for the reversibility of adverse intergenerational effects, including linear growth failure.

Public Health Relevance

Pre- and postnatal growth is associated with greater morbidity and mortality and with long-term loss of human capital. Nutrition interventions during pregnancy or infancy in resource-poor populations are only partially successful in decreasing growth failure. This proposal tests the hypothesis that benefits to offspring of maternal nutrition interventions are greatly enhanced when commenced prior to conception.

National Institute of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
Application #
Study Section
Special Emphasis Panel (ZHD1)
Program Officer
Koso-Thomas, Marion
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
University of Colorado Denver
Schools of Medicine
United States
Zip Code
Hibberd, Patricia L; Hansen, Nellie I; Wang, Marie E et al. (2016) Trends in the incidence of possible severe bacterial infection and case fatality rates in rural communities in Sub-Saharan Africa, South Asia and Latin America, 2010-2013: a multicenter prospective cohort study. Reprod Health 13:65
Garces, Ana; Mcclure, Elizabeth M; Hambidge, K et al. (2015) Trends in perinatal deaths from 2010 to 2013 in the Guatemalan Western Highlands. Reprod Health 12 Suppl 2:S14
Bose, Carl L; Bauserman, Melissa; Goldenberg, Robert L et al. (2015) The Global Network Maternal Newborn Health Registry: a multi-national, community-based registry of pregnancy outcomes. Reprod Health 12 Suppl 2:S1
Chomba, Elwyn; Westcott, Claire M; Westcott, Jamie E et al. (2015) Zinc absorption from biofortified maize meets the requirements of young rural Zambian children. J Nutr 145:514-9
Harrison, Margo S; Ali, Sumera; Pasha, Omrana et al. (2015) A prospective population-based study of maternal, fetal, and neonatal outcomes in the setting of prolonged labor, obstructed labor and failure to progress in low- and middle-income countries. Reprod Health 12 Suppl 2:S9
Bauserman, Melissa; Lokangaka, Adrien; Thorsten, Vanessa et al. (2015) Risk factors for maternal death and trends in maternal mortality in low- and middle-income countries: a prospective longitudinal cohort analysis. Reprod Health 12 Suppl 2:S5
Marete, Irene; Tenge, Constance; Chemweno, Carolyne et al. (2015) Lost to follow-up among pregnant women in a multi-site community based maternal and newborn health registry: a prospective study. Reprod Health 12 Suppl 2:S4
Althabe, Fernando; Moore, Janet L; Gibbons, Luz et al. (2015) Adverse maternal and perinatal outcomes in adolescent pregnancies: The Global Network's Maternal Newborn Health Registry study. Reprod Health 12 Suppl 2:S8
Patel, Archana; Bucher, Sherri; Pusdekar, Yamini et al. (2015) Rates and determinants of early initiation of breastfeeding and exclusive breast feeding at 42 days postnatal in six low and middle-income countries: A prospective cohort study. Reprod Health 12 Suppl 2:S10
Bogale, Alemtsehay; Clarke, Stephen L; Fiddler, Joanna et al. (2015) Zinc Supplementation in a Randomized Controlled Trial Decreased ZIP4 and ZIP8 mRNA Abundance in Peripheral Blood Mononuclear Cells of Adult Women. Nutr Metab Insights 8:7-14

Showing the most recent 10 out of 41 publications