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Cited by 56Birth, Development, and HealthMaternal and Neonatal HealthcarePublic Health and Nutrition

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)

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Norris, Shane A, Draper, Catherine E, Prioreschi, Alessandra, Smuts, CM, Ware, Lisa Jayne, Dennis, CindyLee, Awadalla, Philip, Bassani, D +28 more·2022·BMJ Open
DOI 10.1136/bmjopen-2021-059914PMC PMC9024255
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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 height 2) 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.

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Authors
Norris, S. A., Draper, C. E., Prioreschi, A., Smuts, C., Ware, L. J., Dennis, C., Awadalla, P., Bassani, D., Bhutta, Z., Briollais, L., Cameron, D. W., Chirwa, T., Fallon, B., Gray, C., Hamilton, J., Jamison, J., Jaspan, H., Jenkins, J., Kahn, K., Kengne, A., Lambert, E. V., Levitt, N., Martin, M.-C., Ramsay, M., Roth, D., Scherer, S., Sellen, D., Slemming, W., Sloboda, D., Szyf, M., Tollman, S., Tomlinson, M., Tough, S., Matthews, S. G., Richter, L., & Lye, S.
Affiliations
  • South African Medical Research Council (ZA)
  • Centre of Excellence of Nutrition, North-West University, Potchefstroom, South Africa
  • Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, Toronton, Ontario, Canada
  • Ontario Institute for Cancer Research (CA)
  • Sickkids Research Institute (CA)
  • Aga Khan University (PK)
  • Lunenfeld-Tanenbaum Research Institute (CA)
  • Ottawa Hospital (CA)
  • University of the Witwatersrand (ZA)
  • University of Toronto (CA)
  • Division of Molecular Biology and Human Genetics, University of Stellenbosch, Stellenbosch, South Africa
  • Red River College (CA)
  • University of Cape Town (ZA)
  • Non-communicable Diseases Research Unit, South African Medical Research Council, Cape Town, South Africa
  • Sydney Brenner Institute for Molecular Bioscience, University of the Witwatersrand, Johannesburg, South Africa
  • McMaster University (CA)
  • Department of Pharmacology and Therapeutics, McGill University, Montreal, Quebec, Canada
  • Stellenbosch University (ZA)
  • Alberta Children's Hospital Research Institute (CA)
Corresponding author
Norris, Shane A
ORCID
Venue
BMJ Open
Publisher
BMJ
Published
2022-04
Volume
12
Issue
4
Pages
e059914
ISSN
2044-6055 (ISSN-L)
DOI
10.1136/bmjopen-2021-059914
PMC
PMC9024255
OpenAlex
W4224238503
Cited by
56
References
3
Citations by year
2026: 11 · 2025: 14 · 2024: 16 · 2023: 9 · 2022: 6
FWCI
12.34
Type
journal article
Language
en
Open access
Licence
Locations
  • BMJ Open (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • ePrints Soton (University of Southampton) (acceptedVersion, other-oa)
  • TSpace (University of Toronto) (submittedVersion, cc-by)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
  • eCommons - AKU (Aga Khan University) (submittedVersion, cc-by)
Funders
  • South African Medical Research Council (N/A)
  • Canadian Institutes of Health Research (HLS 151553)
Topics
  • Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Birth, Development, and Health
  • Health Sciences › Health Professions › General Health Professions › Maternal and Neonatal Healthcare
  • Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Public Health and Nutrition
Keywords
preconception care, maternal obesity, non-communicable diseases, community health workers, micronutrient supplementation, health literacy, behavior change support, maternal nutrition, maternal mental health, maternal physical activity, offspring adiposity, fat mass index, early childhood development, South African women, urban poverty, Soweto, continuum of care
MeSH terms
Child, Child, Preschool, Community Health Workers, Female, Health Status, Humans, Male, Mental Health, Obesity, Pregnancy, South Africa

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