Deux Oeufs: cracking the potential of eggs to improve child growth and development - a randomized controlled trial (RCT) study protocol.

BACKGROUND: The first thousand days post-conception are crucial for potential interventions to improve early child growth and development. Adequate nutrition during pregnancy plays a pivotal role in both maternal and child health. Recent studies indicate that the consumption of animal-source foods (ASF) such as eggs during childhood may have a positive effect on child growth and development. However, limited evidence exists for the impact of egg supplementation during pregnancy on maternal and child nutrition. The Deux Oeufs study aims to test the effect of a maternal nutritional intervention of two eggs per day during pregnancy on birth outcomes and infant growth. METHODS: Deux Oeufs is a randomized controlled trial (RCT) and will aim to enroll and randomize 956 pregnant women from Nyagatare District in Rwanda into one of two study arms: a treatment group (T1) or a control group (T2). Women in the treatment arm will consume a supplement of two eggs per day starting from enrollment during the first trimester of pregnancy until childbirth. The study staff will directly observe the consumption of eggs daily. Women in the control arm will continue their usual diet. All enrolled participants will receive standard prenatal care, as outlined by the Government of Rwanda (GoR), a mobile phone, health insurance (if not already covered), and modest compensation for participation. All participants who are not already receiving Shisha Kibondo (a fortified flour supplement provided by GoR) as part of their standard care will receive the same amount (6 kg/month) from the study, regardless of treatment arm. The primary outcome is child length-for-age z-score (LAZ) at birth. Secondary outcomes include maternal health indicators (during and after pregnancy) and child growth and early development measures both in utero, during the second and third trimesters, after birth, and at 6 weeks and 6 months of age. Women will be enrolled on a rolling basis starting from May 2024. DISCUSSION: Deux Oeufs is the first RCT to test the effects of directly observed daily maternal egg consumption during pregnancy on child nutrition outcomes. Findings from the study will provide evidence on the potential for prenatal ASF supplementation to improve child growth and development and consequently inform policy decisions. TRIAL REGISTRATION: ClinicalTrials.gov NCT06405360. Registered on May 03, 2024.