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

Shane A Norris, Catherine E Draper, Alessandra Prioreschi, C M Smuts, Lisa Jayne Ware, CindyLee Dennis, Philip Awadalla, D Bassani, Zulfiqar Bhutta, Laurent Briollais, D William Cameron, Tobias Chirwa, B Fallon, C M Gray, Jill Hamilton, J Jamison, Heather Jaspan, Jennifer Jenkins, Kathleen Kahn, A P Kengne, Estelle V Lambert, Naomi Levitt, Marie-Claude Martin, Michele Ramsay, Daniel Roth, Stephen Scherer, Daniel Sellen, Wiedaad Slemming, Deborah Sloboda, M Szyf, Stephen Tollman, Mark Tomlinson, Suzanne Tough, Stephen G Matthews, Linda Richter, Stephen Lye

Journal: BMJ open 2022;12(4):e059914

PMID: 35450913

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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

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) 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.

Address: SAMRC Developmental Pathways for Health Research Unit, Department of Paediatrics, University of the Witwatersrand, Johannesburg-Braamfontein, South Africa [email protected].; Global Health Research Institute, School of Human Development and Health, University of Southampton, Southampton, UK.; SAMRC Developmental Pathways for Health Research Unit, Department of Paediatrics, University of the Witwatersrand, Johannesburg-Braamfontein, South Africa.; Centre of Excellence of Nutrition, North-West University, Potchefstroom, South Africa.; SAMRC Developmental Pathways for Health Research Unit, Department of Paediatrics, University of the Witwatersrand, Johannesburg-Braamfontein, South Africa.; DSI-NRF Centre of Excellence in Human Development, University of the Witwatersrand, Johannesburg, South Africa.; Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, Toronton, Ontario, Canada.; Department of Molecular Genetics, Ontario Institute for Cancer Research, University of Toronto, Toronto, Ontario, Canada.; Centre for Global Child Health, SickKids Research Institute, Toronto, Ontario, Canada.; Centre for Global Child Health, SickKids Research Institute, Toronto, Ontario, Canada.; Institute for Global Health and Development, Aga Khan University, Karachi, Pakistan.; Lunenfeld-Tanenbaum Research Institute, Toronto, Ontario, Canada.; Medicine, Division of Infectious Diseases, Ottawa Hospital General Campus, Ottawa, Ontario, Canada.; Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.; School of Public Health, University of the Witwatersrand, Johannesburg, South Africa.; Factor-Inwentash Faculty of Social Work, University of Toronto, Toronto, Ontario, Canada.; Division of Molecular Biology and Human Genetics, University of Stellenbosch, Stellenbosch, South Africa.; Division of Immunology, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Rondebosch, South Africa.; Department of Paediatrics, University of Toronto, Toronto, Ontario, Canada.; Community Services, Red River College, Winnipeg, Manitoba, Canada.; Division of Immunology, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Rondebosch, South Africa.; Department of Applied Psychology and Human Development, University of Toronto, Toronto, Ontario, Canada.; School of Public Health, University of the Witwatersrand, Johannesburg, South Africa.; SAMRC Rural Public Health and Health Transitions Research Unit (Agincourt), Uinversity of the Witwatersrand, Johannesburg, South Africa.; Non-communicable Diseases Research Unit, South African Medical Research Council, Cape Town, South Africa.; Division of Exercise Science and Sports Medicine, University of Cape Town, Rondebosch, South Africa.; Chronic Diseases Initiative for Africa, University of Cape Town, Cape Town, South Africa.; Sydney Brenner Institute for Molecular Bioscience, University of the Witwatersrand, Johannesburg, South Africa.; Department of Paediatrics, University of Toronto, Toronto, Ontario, Canada.; The Hospital for Sick Children, Toronto, Ontario, Canada.; The Hospital for Sick Children, Toronto, Ontario, Canada.; Department of Molecular Genetics, University of Toronto, Toronto, Ontario, Canada.; Department of Nutritional Sciences, University of Toronto, Toronto, Ontario, Canada.; Department of Paediatrics, University of the Witwatersrand, Johannesburg-Braamfontein, South Africa.; Department of Biochemistry and Biomedical Sciences, McMaster University, Hamilton, Ontario, Canada.; Department of Pharmacology and Therapeutics, McGill University, Montreal, Quebec, Canada.; Institute for Life Course Health Research, University of Stellenbosch, Cape Town, South Africa.; Department of Paediatrics, Alberta Children's Hospital Research Institute, Calgary, Alberta, Canada.; Lunenfeld-Tanenbaum Research Institute, Toronto, Ontario, Canada.; Department of Physiology, Obstetrics & Gynaecology and Medicine, University of Toronto, Toronto, Ontario, Canada.; DSI-NRF Centre of Excellence in Human Development, University of the Witwatersrand, Johannesburg, South Africa.; SAMRC Developmental Pathways for Health Research Unit, Department of Paediatrics, University of the Witwatersrand, Johannesburg-Braamfontein, South Africa.; Lunenfeld-Tanenbaum Research Institute, Toronto, Ontario, Canada.; Department of Physiology, Obstetrics & Gynaecology and Medicine, University of Toronto, Toronto, Ontario, Canada.

DOI: 10.1136/bmjopen-2021-059914

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MeSH Terms: Child, Child, Preschool, Community Health Workers, Female, Health Status, Humans, Mental Health, Obesity, Pregnancy, South Africa