Maternal & Child Health

Distributions, Predictors, and Consequences of Gestational Weight Gain in Low and Middle-Income Countries (GWG Pooling Project) - Phase II

Project Dates: 09/10/2020 – 03/31/2024

Principal Investigator: Wafaie Fawzi

We have recently completed the first phase of this effort, during which over 50 studies globally contributed their data. Phase 1 focused on preliminarily describing the geographic distribution of GWG using cross-sectional data, assessing determinants and outcomes of GWG, and investigating the impact of antenatal multiple micronutrient supplements and small-quantity lipid-based nutrient supplements on GWG, in LMICs.

We are now in the next phase of this effort, during which we are aiming to:

  • Characterize the geographic distributions of GWG in LMICs;
  • Identify dietary and psychosocial predictors of GWG in LMICs;
  • Evaluate the impact of antenatal balanced energy and protein supplementation as well as antenatal anti-infectious agents on GWG in LMICs;
  • Examine the associations of GWG with postpartum maternal and child outcomes in LMICs; and
  • Develop globally applicable GWG reference charts and recommended ranges for GWG.

Ignite 2: Quantifying the impact of selected maternal and child nutritional interventions on non-communicable diseases

Project Dates: 06/03/2022 – 03/31/2024

Principal Investigator: Goodarz Danaei 

The major goals of this project are to inform evidence-based action against the double-burden of malnutrition in low- and middle-income populations by quantifying the impact of select nutritional interventions on intergenerational outcomes especially related to non-communicable disease in offspring in LMICs.

Family planning and anemia: an assessment of evidence and opportunities

Project Dates: 10/31/2022 – 04/30/2024

Principal Investigator: Wafaie Fawzi

The major goals of this project are to inform both MNCH and Family Planning strategic priorities in better understanding the biological links between family planning and anemia as well as opportunities for integrated intervention. It will help answer the question within the Maternal Anemia Body of Work of: How do we scale-up effective coverage of anemia prevention packages (nutritional supplementation, infection control, screening, and referral) into routine service delivery?

Effects of micronutrient supplementation on maternal and infant micronutrient status: a secondary analysis for Tanzania, and a systematic review and meta-analysis for low- and middle-income countries

Project Dates: 11/17/2021 – 05/14/2024

Principal Investigator: Wafaie Fawzi

The purpose of this two-aim project is to 1) Aim 1: conduct a secondary analysis using stored maternal and infant biospecimens (plasma and breast milk) from a previous randomized controlled trial in Tanzania to examine the impacts of maternal micronutrient supplements during pregnancy and lactation on maternal and infant B-vitamin status; and 2) Aim 2: conduct a systematic review and meta-analysis on the impacts of maternal vitamin supplementation on maternal and infant nutritional status. The findings of this work will inform the design of future nutrition interventions among women of reproductive age in resource-limited settings.

Demonstrating non-inferiority of a lower dose (500 mg) calcium supplementation during pregnancy for reducing preeclampsia (PE) and neonatal outcomes

Project Dates: 10/15/2017 – 06/30/2024

Principal Investigator: Wafaie Fawzi

The objective of this study is to generate causal evidence for decision-making on the potential non-inferiority of a lower dose of calcium in preventing preeclampsia and preterm birth and to understand the acceptability, uptake, and adherence to the WHO recommended 1500 mg calcium supplementation among pregnant women in Tanzania and India. We will conduct two, parallel individually randomized, double blind trials in Bangalore, India and Dar es Salaam, Tanzania. Each woman will be randomized to either standard dose (1500 mg) or low dose (500 mg) calcium supplementation. The primary outcomes of the study are: i) preeclampsia, ii) preterm birth. A parallel, mixed-methods implementation cohort study will also be conducted at one additional health facility in each country to assess the barriers and enablers of health system implementation and individual acceptability and compliance of the WHO-recommended 1500 mg calcium supplementation regimen.

Low dose CA trial: secondary analyses to inform pre-eclampsia definitions

Project Dates: 11/14/2022 – 06/30/2024

Principal Investigator: Wafaie Fawzi

The major goals of this project are to support secondary analyses of the low dose CA data to inform definitions of PE and provide evidence for counseling for its management in low resource settings by: Evaluating prevalence and risk factors for PE subtypes (early onset PE, PE with severe features, PE co-presenting with chronic hypertensions) overall and by site and evaluate associations between PE subtype and adverse pregnancy outcomes.

Non-inferiority trial of lower-dose iron (30mg, 45 mg) compared to high dose iron (60mg) in multiple micronutrient supplements in pregnancy on maternal and infant outcomes: A randomized trial in Tanzania

Project Dates: 10/31/2022 – 09/30/2025

Principal Investigator: Christopher Sudfeld

The overall project goal is to assess the non-inferiority of multiple micronutrient supplements (MMS) containing 30 mg and 45 mg iron as compared to MMS containing 60 mg iron on maternal, fetal, and infant health outcomes in Tanzania.

Effectiveness and feasibility of BEP targeting strategies.

Project Dates: 07/26/2022 – 12/31/2025

Principal Investigator: Wafaie Fawzi

The study will address critical implementation questions regarding how to effectively target and deliver balanced energy protein supplements (BEP) to malnourished pregnant women. The results of this research will inform global recommendations and operational guidelines for BEP delivery.

Given the significant gaps on the most acceptable and cost-effective way to scale up antenatal balanced energy protein supplements (BEP) supplements in resource-limited settings, we propose an effectiveness study in Ethiopia to evaluate the effectiveness, cost-effectiveness, and implementational aspects of different targeting strategies of providing antenatal BEP supplements. The study will cover the population-based targeting approach recommended by the WHO and individual-based targeting approaches, including a novel approach based on the iterative evaluation of gestational weight gain during pregnancy.

Randomized controlled trial to evaluate the effect of microbiome-directed complementary foods in the recovery from acute malnutrition in Niger

Project Dates: 11/15/2021-11/30/2026

Principal Investigator: Sheila Isanaka

The purpose of this grant is to evaluate the efficacy of microbiome-directed complementary foods as compared to standard ready-to-use supplemental or therapeutic foods (RUSF/RUTF) on 12-week recovery and 24- week sustained recovery for children with moderate acute malnutrition and severe acute malnutrition. The trial will also evaluate the effect of the MDCF on the microbiome and important immune biomarkers.

Nutritional management of growth faltering in infants aged under six months in Asia and Africa, an individually randomized trial (0-6)

Project Dates: 01/01/2024 – 12/31/2026

Principal Investigator: Wafaie Fawzi

The overall aim of this study is to determine the effect of nutritional supplementation plus intensive breastfeeding support compared with intensive breastfeeding support alone on mortality, morbidity and growth in infants aged 0-6 months with growth faltering in low resource settings in South Asia and Sub-Saharan Africa.

Trial of Zinc Supplements for Young Infants with Clinical Severe Infection in Tanzania

Project Dates: 02/17/2023 – 01/31/2028

Principal Investigator: Christopher Sudfeld

The overall project goal is to investigate zinc supplementation in combination with standard antibiotic therapy as a simple, low-cost, and readily available intervention to improve survival and treatment outcomes for Tanzanian young infants hospitalized with ‘clinical severe infection’ as defined by WHO IMCI criteria. To meet these goals, we propose to conduct a ‘gold standard’ randomized, double-blind, placebo-controlled trial of zinc supplementation in Dar es Salaam, Tanzania.