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)
Date
2022-03-25
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Abstract
is challenging due to a persistent infectious disease,
burgeoning obesity, most notably among women and
rising rates of non-communicable diseases (NCDs). With
two thirds of women presenting at their first antenatal
visit either overweight or obese in urban South Africa (SA),
the preconception period is an opportunity to optimise
health and offset transgenerational risk of both obesity
and NCDs.
Methods and analysis Bukhali is the first individual
randomised controlled trial in Africa to test the efficacy of
a complex continuum of care intervention and forms part
of the Healthy Life Trajectories Initiative (HeLTI) consortium
implementing harmonised trials in Canada, China, India
and SA. Starting preconception and continuing through
pregnancy, infancy and childhood, the intervention is
designed to improve nutrition, physical and mental health
and health behaviours of South African women to offset
obesity-risk (adiposity) in their offspring. Women aged
18–28 years (n=6800) will be recruited from Soweto, an
urban-poor area of Johannesburg. The primary outcome
is dual-energy X-ray absorptiometry derived fat mass
index (fat mass divided by height2
) in the offspring at
age 5 years. Community health workers will deliver the
intervention randomly to half the cohort by providing
health literacy material, dispensing a multimicronutrient
supplement, providing health services and feedback, and
facilitating behaviour change support sessions to optimise:
(1) nutrition, (2) physical and mental health and (3) lay the foundations for healthier pregnancies and early child
development.
Ethics and dissemination Ethical approval has been
obtained from the Human Ethics Research Committee
University of the Witwatersrand, Johannesburg,
South Africa (M1811111), the University of Toronto,
Canada (19-0066-E) and the WHO Ethics Committee
(ERC.0003328). Data and biological sample sharing
policies are consistent with the governance policy of the
HeLTI Consortium (https://helti.org) and South African
government legislation (POPIA). The recruitment and
research team will obtain informed consent.