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).

Journal: BMJ open

Volume: 12

Issue: 4

Year of Publication: 2022

Affiliated Institutions:  SAMRC Developmental Pathways for Health Research Unit, Department of Paediatrics, University of the Witwatersrand, Johannesburg-Braamfontein, South Africa shane.norris@wits.ac.za. 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. 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. Lunenfeld-Tanenbaum Research Institute, Toronto, Ontario, Canada. Medicine, Division of Infectious Diseases, Ottawa Hospital General Campus, 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. 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. 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. The Hospital for Sick Children, 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. DSI-NRF Centre of Excellence in Human Development, University of the Witwatersrand, Johannesburg, South Africa.

Abstract summary 

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. 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.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.This trial is registered with the Pan African Clinical Trials Registry (https://pactr.samrc.ac.za) on 25 March 2019 (identifier: PACTR201903750173871).20 March 2022 (version #4). Any protocol amendments will be communicated to investigators, Institutional Review Board (IRB)s, trial participants and trial registries.

Authors & Co-authors:  Norris Shane A SA Draper Catherine E CE Prioreschi Alessandra A Smuts C M CM Ware Lisa Jayne LJ Dennis CindyLee C Awadalla Philip P Bassani D D Bhutta Zulfiqar Z Briollais Laurent L Cameron D William DW Chirwa Tobias T Fallon B B Gray C M CM Hamilton Jill J Jamison J J Jaspan Heather H Jenkins Jennifer J Kahn Kathleen K Kengne A P AP Lambert Estelle V EV Levitt Naomi N Martin Marie-Claude MC Ramsay Michele M Roth Daniel D Scherer Stephen S Sellen Daniel D Slemming Wiedaad W Sloboda Deborah D Szyf M M Tollman Stephen S Tomlinson Mark M Tough Suzanne S Matthews Stephen G SG Richter Linda L Lye Stephen S

Study Outcome 

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Statistics
Citations :  GBD 2015 Mortality and Causes of Death Collaborators . Global, regional, and national life expectancy, all-cause mortality, and cause-specific mortality for 249 causes of death, 1980-2015: a systematic analysis for the global burden of disease study 2015. Lancet 2016;388:1459–544. 10.1016/S0140-6736(16)31012-1
Authors :  36
Identifiers
Doi : e059914
SSN : 2044-6055
Study Population
Women
Mesh Terms
Child
Other Terms
nutrition & dietetics;public health;social medicine
Study Design
Cohort Study,Case Control Trial,Cross Sectional Study
Study Approach
Country of Study
South Africa
Publication Country
England