A culturally tailored personaliseD nutrition intErvention in South ASIan women at risk of Gestational Diabetes Mellitus (DESI-GDM): a randomised controlled trial protocol
Russell J de Souza,
Scott A Lear,
Harpreet S Bajaj,
Gita Wahi,
Sarah D McDonald,
Sonia S Anand,
Sujane Kandasamy,
Diana Sherifali,
Michael A Zulyniak,
Dipika Desai,
Kristi B Adamo,
Shrikant I Bangdiwala,
Hertzel C Gerstein,
Natalie C Williams,
Paul Ritvo,
Rosain N Stennett,
Farah Khan,
Tayler Pocsai,
Andrea Rogge,
Karleen M Schulze,
Jennifer C Stearns
Affiliations
Russell J de Souza
Population Health Research Institute, Hamilton, Ontario, Canada
Scott A Lear
Population Health Research Institute, Hamilton, Ontario, Canada
Harpreet S Bajaj
LMC Healthcare, Toronto, Ontario, Canada
Gita Wahi
Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada
Sarah D McDonald
Department of Health Research Methods, Evidence, and Impact, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada
Sonia S Anand
Department of Health Research Methods, Evidence, and Impact, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada
Sujane Kandasamy
Department of Health Research Methods, Evidence, and Impact, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada
Diana Sherifali
School of Nursing, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada
Michael A Zulyniak
Food Science and Nutrition, University of Leeds, Leeds, West Yorkshire, UK
Dipika Desai
Department of Health Research Methods, Evidence, and Impact, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada
Kristi B Adamo
School of Human Kinetics, Faculty of Health Sciences, University of Ottawa, Ottawa, Ontario, Canada
Shrikant I Bangdiwala
Department of Health Research Methods, Evidence, and Impact, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada
Hertzel C Gerstein
10 Department of Medicine, McMaster University, Hamilton, Ontario, Canada
Natalie C Williams
Department of Medicine, McMaster University, Hamilton, Ontario, Canada
Paul Ritvo
Kinesiology and Health Science, York University, Toronto, Ontario, Canada
Rosain N Stennett
Department of Health Research Methods, Evidence, and Impact, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada
Farah Khan
Population Health Research Institute, Hamilton, Ontario, Canada
Tayler Pocsai
Population Health Research Institute, Hamilton, Ontario, Canada
Andrea Rogge
Population Health Research Institute, Hamilton, Ontario, Canada
Karleen M Schulze
Department of Medicine, McMaster University, Hamilton, Ontario, Canada
Jennifer C Stearns
Department of Medicine, McMaster University, Hamilton, Ontario, Canada
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.
