Peer-reviewed article
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)
Shane Anthony Norris, Catherine Elizabeth Draper, Alessandra Prioreschi, Cornelius Mattheus Smuts, Lisa Jayne Ware et al. ·
Summary
Written by AI, not yet AICS's view · claude-haiku-4-5-20251001Bukhali is a randomised controlled trial in Soweto, South Africa, testing whether an intervention delivered by community health workers can improve women's nutrition, physical and mental health before and during pregnancy to reduce obesity risk in their children. The intervention provides health literacy, multimicronutrient supplements, health services and behaviour change support to women aged 18-28 years. The study will follow 6,800 women and their offspring, measuring body fat in children at age 5 years as the main outcome. This is part of a larger international consortium testing similar approaches in four countries.
Key points
- Two-thirds of women in urban South Africa present at first antenatal visit overweight or obese
- The preconception period is identified as an opportunity to optimise health and reduce transgenerational obesity and non-communicable disease risk
- Community health workers deliver the intervention through health literacy, micronutrient supplementation, health services and behaviour change support
- Primary outcome is offspring fat mass index measured by dual-energy X-ray absorptiometry at age 5 years
- The study is part of the Healthy Life Trajectories Initiative, a harmonised consortium implementing trials in Canada, China, India and South Africa
Limitations
This is a protocol paper describing the trial design and does not yet report results, so the effectiveness of the intervention is unknown. The document does not provide information on implementation fidelity, participant adherence, or any preliminary outcome data.
Abstract
Introduction South Africa’s evolving burden of disease 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. Trial registration This trial is registered with the Pan African Clinical Trials Registry ( https://pactr.samrc.ac.za ) on 25 March 2019 (identifier: PACTR201903750173871). Protocol version 20 March 2022 (version #4). Any protocol amendments will be communicated to investigators, Institutional Review Board (IRB)s, trial participants and trial registries.
Findings the Hub has extracted
Each claim below is labelled by its type of design and links back to this report.
- Intervention
- Complex continuum of care intervention delivered by community health workers from preconception through pregnancy, infancy and childhood, including health literacy material, multimicronutrient supplementation, health services and feedback, and behaviour change support sessions targeting nutrition, p
- Population
- Women aged 18-28 years (n=6,800) recruited from Soweto, an urban-poor area of Johannesburg, South Africa, and their offspring followed through age 5 years
Key finding
Primary outcome is offspring fat mass index at age 5 years measured by dual-energy X-ray absorptiometry
Norris et al. · Prof. Linda Richter (OpenAlex works) · 1 Apr 2022