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

doi:10.3389/fnut.2023.1336509

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

Front Nutr. 2024 Jan 19:10:1336509. doi: 10.3389/fnut.2023.1336509. eCollection 2023.

Authors

Emilie Bernier^{1

2

3}, Anne-Sophie Plante^{2

3}, Patricia Lemieux^{2

4}, Julie Robitaille^{1

2

3}, Simone Lemieux^{1

3}, Sophie Desroches^{1

3}, Ariane Bélanger-Gravel^{3

5

6}, Sarah Maheux-Lacroix^{2

4}, S John Weisnagel^{2

4}, Suzanne Demers⁴, Félix Camirand Lemyre^{7

8}, Mélanie Boulet⁹, Jean-Patrice Baillargeon^{8

10}, Anne-Sophie Morisset^{1

2

3}

Affiliations

¹ École de Nutrition, Université Laval, Québec, QC, Canada.
² Centre de Recherche du CHU de Québec-Université Laval, Québec, QC, Canada.
³ Centre de Recherche Nutrition, Santé et Société (NUTRISS) de l'Institut sur la Nutrition et des Aliments Fonctionnels (INAF), Université Laval, Québec, QC, Canada.
⁴ Faculté de Médecine, Université Laval, Québec, QC, Canada.
⁵ Département de Communication, Université Laval, Québec, QC, Canada.
⁶ Centre de Recherche de l'Institut Universitaire de Cardiologie de Pneumologie de Québec, Québec, QC, Canada.
⁷ Département de Mathématiques, Université de Sherbrooke, Sherbrooke, QC, Canada.
⁸ Centre de Recherche du CHU de Sherbrooke, Sherbrooke, QC, Canada.
⁹ Centre Intégré Universitaire de Santé et de Service Sociaux de l'Estrie-CHU de Sherbrooke, Sherbrooke, QC, Canada.
¹⁰ Département de Médecine, Université de Sherbrooke, Sherbrooke, QC, Canada.

Abstract

Background: Healthy 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.

Aims: This 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.

Methods: Population: 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.

Discussion: This 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 registration: https://clinicaltrials.gov/study/NCT05299502, NCT05299502.

Keywords: diet quality; gestational diabetes mellitus; healthy eating; intervention; nutrition; pregnancy; randomized control trial.

Associated data

ClinicalTrials.gov/NCT05299502

Grants and funding

The author(s) declare financial support was received for the research, authorship, and/or publication of this article. This study is mainly funded by the Canadian Institutes of Health Research (#486744). Start-up fundings were also received from the Axe Endocrinologie et Néphrologie of the Centre de recherche du CHU de Québec-Université Laval, the Centre de recherche Nutrition Santé et Société (NUTRISS) of the Institut sur la nutrition et des aliments fonctionnels, Université Laval), as well as from the Centre de recherche en reproduction et développement et santé intergénérationnelle (CRDSI) of the Université Laval. EB received graduate scholarship awards from the Canadian Institutes of Health Research and the Fonds de recherche en Santé du Québec. A-SM received a research scholar Junior 2 from the Fonds de recherche en Santé du Québec. Funding agencies had no role in designing this study or in writing this manuscript.