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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)

Authors :
Stephen Tollman
Kathleen Kahn
Shane A Norris
Heather Jaspan
Naomi Levitt
Suzanne Tough
Mark Tomlinson
Estelle V Lambert
Linda Richter
CM Gray
Zulfiqar Bhutta
Tobias Chirwa
D William Cameron
Michèle Ramsay
Lisa Jayne Ware
AP Kengne
Stephen Lye
Stephen G Matthews
Stephen Scherer
Daniel Sellen
Marie-Claude Martin
D Bassani
J Jamison
Jill Hamilton
Catherine E Draper
Jennifer Jenkins
Alessandra Prioreschi
CM Smuts
CindyLee Dennis
Laurent Briollais
B Fallon
Daniel Roth
Wiedaad Slemming
Deborah Sloboda
M Szyf
Source :
BMJ Open, Vol 12, Iss 4 (2022)
Publication Year :
2022
Publisher :
BMJ Publishing Group, 2022.

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.

Subjects

Subjects :
Medicine

Details

Language :
English
ISSN :
20446055
Volume :
12
Issue :
4
Database :
Directory of Open Access Journals
Journal :
BMJ Open
Publication Type :
Academic Journal
Accession number :
edsdoj.72069b97126e4c94a58059f53b74b1a2
Document Type :
article
Full Text :
https://doi.org/10.1136/bmjopen-2021-059914