Building knowledge, optimising physical and mental health and setting up healthier life trajectories in South African women (Bukhali): a preconception randomised control trial part of the Healthy Life Trajectories Initiative (HeLTI)

Participants: women aged 18-28 years from Soweto, urban poor area of Johannesburg, not pregnant at baseline; total planned n=6800. Design: individually randomized controlled trial (two-arm, 1:1) comparing MMN intervention vs standard of care; allocation via computer-generated randomization with concealed envelopes; investigators and data collection teams blinded to allocation; intervention delivered by community health workers; eligibility exclusions included diagnosed type 1 diabetes or epilepsy and intellectual disability hindering consent.

Multimicronutrient supplement (MMN) containing iron 27 mg per dose plus other micronutrients (Table 1). Dosing by maternal haemoglobin at enrolment: non-anaemic (Hb ≥12 g/dL) iron 27 mg twice weekly; mildly anaemic (Hb <12 g/dL and >7 g/dL) daily for 6 months; severely anaemic (Hb <7 g/dL) receive treatment per standard guidelines. Duration: from preconception through the preconception period until pregnancy or exit; if pregnancy occurs, daily supplementation throughout pregnancy and for 6 months postpartum. How taken: orally (per dose schedule). Nutrient content includes vitamin A, D, E, K1, B vitamins, folic acid, iron, zinc, copper, iodine, selenium, etc., as listed in the supplement composition.

No economic evaluation included; recruitment and trial conduct were impacted by the COVID-19 pandemic with adaptations (e.g., some remote delivery), which may affect interpretation and generalisability; potential cross-site delivery heterogeneity.