Stennett RN, Adamo KB, Anand SS, Bajaj HS, Bangdiwala SI, Desai D, Gerstein HC, Kandasamy S, Khan F, Lear SA, McDonald SD, Pocsai T, Ritvo P, Rogge A, Schulze KM, Sherifali D, Stearns JC, Wahi G, Williams NC, Zulyniak MA, and de Souza RJ
Introduction: South Asians are more likely to develop gestational diabetes mellitus (GDM) than white Europeans. Diet and lifestyle modifications may prevent GDM and reduce undesirable outcomes in both the mother and offspring. Our study seeks to evaluate the effectiveness and participant acceptability of a culturally tailored, personalised nutrition intervention on the glucose area under the curve (AUC) after a 2-hour 75 g oral glucose tolerance test (OGTT) in pregnant women of South Asian ancestry with GDM risk factors., Methods and Analysis: A total of 190 South Asian pregnant women with at least 2 of the following GDM risk factors-prepregnancy body mass index>23, age>29, poor-quality diet, family history of type 2 diabetes in a first-degree relative or GDM in a previous pregnancy will be enrolled during gestational weeks 12-18, and randomly assigned in a 1:1 ratio to: (1) usual care, plus weekly text messages to encourage walking and paper handouts or (2) a personalised nutrition plan developed and delivered by a culturally congruent dietitian and health coach; and FitBit to track steps. The intervention lasts 6-16 weeks, depending on week of recruitment. The primary outcome is the glucose AUC from a three-sample 75 g OGTT 24-28 weeks' gestation. The secondary outcome is GDM diagnosis, based on Born-in-Bradford criteria (fasting glucose>5.2 mmol/L or 2 hours post load>7.2 mmol/L)., Ethics and Dissemination: The study has been approved by the Hamilton Integrated Research Ethics Board (HiREB #10942). Findings will be disseminated among academics and policy-makers through scientific publications along with community-orientated strategies., Trial Registration Number: NCT03607799., Competing Interests: Competing interests: HSB has received Grants/Research Support (paid to his institution) from the following: Amgen, Anji, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Kowa, New Amsterdam, Novartis, Novo Nordisk, Pfizer, Public Health Agency of Canada (PHAC) and Sanofi. HCG holds the McMaster-Sanofi Population Health Institute Chair in Diabetes Research and Care. He reports research grants from Eli Lilly, AstraZeneca, Novo Nordisk, and Sanofi; honoraria for speaking from AstraZeneca, Boehringer Ingelheim, Eli Lilly, Novo Nordisk, DKSH, Zuellig, Roche, Sanofi, Jiangsu Hanson, and Carbon Brand; and consulting fees from Abbott, Eli Lilly, Novo Nordisk, Sanofi, Kowa, Pfizer, Hanmi and Viatris. SK received a CIHR video talks Prize for the Knowledge Translation (KT) video created for the South Asian Grandmothers Qualitative Substudy. She was also funded by a CIHR Vanier Doctoral scholarship to develop and evaluate the SMART START KT tools. PR is currently funded by the Canadian Institutes of Health (CIHR) (2021–2025). He coordinates research with NexJ Health, which provides a software platform to convey the psychosocial and psychiatric programming he develops and assesses. PR receives no personal compensations for studies coordinated with NexJ but does receive free-of-charge platform support.GW has held grants from the Canadian Institutes of Health Research and she is currently the recipient of a Research Early Career Award from Hamilton Health Sciences Foundation. MAZ is currently funded by the Wellcome Trust [217446/Z/19/Z] and the Biotechnology and Biological Sciences Research Council [BB/X511869/1]. RJdS has served as an external resource person to the WHO’s Nutrition Guidelines Advisory Group on trans fats, saturated fats and polyunsaturated fats. The WHO paid for his travel and accommodation to attend meetings from 2012 to 2017 to present and discuss this work. He has presented updates of this work to the WHO in 2022. He has also done contract research for the Canadian Institutes of Health Research’s Institute of Nutrition, Metabolism, and Diabetes, Health Canada, and the WHO for which he received remuneration. He has received speaker’s fees from the University of Toronto and McMaster Children’s Hospital. He has held grants from the Canadian Institutes of Health Research, Canadian Foundation for Dietetic Research, Population Health Research Institute and Hamilton Health Sciences Corporation as a principal investigator and is a coinvestigator on several funded team grants from the Canadian Institutes of Health Research. He has served as an independent director of the Helderleigh Foundation (Canada). He serves as a member of the Nutrition Science Advisory Committee to Health Canada (Government of Canada) and a co-opted member of the Scientific Advisory Committee on Nutrition (SACN) Subgroup on the Framework for the Evaluation of Evidence (Public Health England). All other authors declare no conflicts of interest., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)