Frontiers in Nutrition (Jan 2024)

Promoting healthy eating in early pregnancy in individuals at risk of gestational diabetes mellitus: does it improve glucose homeostasis? A study protocol for a randomized control trial

  • Emilie Bernier,
  • Emilie Bernier,
  • Emilie Bernier,
  • Anne-Sophie Plante,
  • Anne-Sophie Plante,
  • Patricia Lemieux,
  • Patricia Lemieux,
  • Julie Robitaille,
  • Julie Robitaille,
  • Julie Robitaille,
  • Simone Lemieux,
  • Simone Lemieux,
  • Sophie Desroches,
  • Sophie Desroches,
  • Ariane Bélanger-Gravel,
  • Ariane Bélanger-Gravel,
  • Ariane Bélanger-Gravel,
  • Sarah Maheux-Lacroix,
  • Sarah Maheux-Lacroix,
  • S. John Weisnagel,
  • S. John Weisnagel,
  • Suzanne Demers,
  • Félix Camirand Lemyre,
  • Félix Camirand Lemyre,
  • Mélanie Boulet,
  • Jean-Patrice Baillargeon,
  • Jean-Patrice Baillargeon,
  • Anne-Sophie Morisset,
  • Anne-Sophie Morisset,
  • Anne-Sophie Morisset

DOI
https://doi.org/10.3389/fnut.2023.1336509
Journal volume & issue
Vol. 10

Abstract

Read online

BackgroundHealthy eating during pregnancy has favorable effects on glycemic control and is associated with a lower risk of gestational diabetes mellitus (GDM). According to Diabetes Canada, there is a need for an effective and acceptable intervention that could improve glucose homeostasis and support pregnant individuals at risk for GDM.AimsThis unicentric randomized controlled trial (RCT) aims to evaluate the effects of a nutritional intervention initiated early in pregnancy, on glucose homeostasis in 150 pregnant individuals at risk for GDM, compared to usual care.MethodsPopulation: 150 pregnant individuals ≥18 years old, at ≤14 weeks of pregnancy, and presenting ≥1 risk factor for GDM according to Diabetes Canada guidelines. Intervention: The nutritional intervention initiated in the first trimester is based on the health behavior change theory during pregnancy and on Canada’s Food Guide recommendations. It includes (1) four individual counseling sessions with a registered dietitian using motivational interviewing (12, 18, 24, and 30 weeks), with post-interview phone call follow-ups, aiming to develop and achieve S.M.A.R.T. nutritional objectives (specific, measurable, attainable, relevant, and time-bound); (2) 10 informative video clips on healthy eating during pregnancy developed by our team and based on national guidelines, and (3) a virtual support community via a Facebook group. Control: Usual prenatal care. Protocol: This RCT includes three on-site visits (10–14, 24–26, and 34–36 weeks) during which a 2-h oral glucose tolerance test is done and blood samples are taken. At each trimester and 3 months postpartum, participants complete web-based questionnaires, including three validated 24-h dietary recalls to assess their diet quality using the Healthy Eating Food Index 2019. Primary outcome: Difference in the change in fasting blood glucose (from the first to the third trimester) between groups. This study has been approved by the Ethics Committee of the Centre de recherche du CHU de Québec-Université Laval.DiscussionThis RCT will determine whether a nutritional intervention initiated early in pregnancy can improve glucose homeostasis in individuals at risk for GDM and inform Canadian stakeholders on improving care trajectories and policies for pregnant individuals at risk for GDM.Clinical trial registrationhttps://clinicaltrials.gov/study/NCT05299502, NCT05299502

Keywords