Healthy Eating in Women at Risk of Gestational Diabetes (SAGE)

Promoting Healthy Eating in Early Pregnancy in Women at Risk of Gestational Diabetes Mellitus: Does it Improve Glucose Homeostasis?

Healthy eating during pregnancy has favorable effects on markers related to diabetes (glucose tolerance) and is associated with lower gestational diabetes mellitus (GDM) risk. The cornerstone of GDM treatment is nutrition therapy but the latter often starts late in pregnancy and thus may not have the expected effects on glucose tolerance. What if an intervention promoting healthy eating was initiated at the beginning of pregnancy in all women at risk, would it improve glucose homeostasis? To answer this important question, the investigators will perform a randomized controlled trial in 150 pregnant women. Women receiving the nutritional intervention will be compared to a control group receiving standard care. The nutritional intervention, which will start in the first trimester, is based on the 2019 Canada's Food Guide and is composed of 4 individual sessions with a registered dietitian (12, 18, 24 and 30 weeks). Between those follow-ups, informative nutritional web capsules and phone calls with the registered dietitian will be provided. To ensure that the women remain motivated and receive social support, a private Facebook group will be used. The investigators hypothesize that the nutritional intervention will be effective at improving glucose homeostasis. The investigators expect the results will show the importance of nutritional care starting early in pregnancy in women at risk of GDM.

Study Overview

• Status: Active, not recruiting
• Conditions: Pregnancy Complications; Gestational Diabetes
• Intervention / Treatment: Behavioral: Nutritional Intervention

Detailed Description

Individuals will participate in three on-site research visits during which a 2-hour oral glucose tolerance test will be performed. At each of these trimesters and 3 months after the delivery, participants will also complete three validated web-based 24-h recalls from which diet quality will be assessed. Subjects will be randomized to two arms after the first oral glucose tolerance test at the first visit. For all participants, on-site follow-ups by the research team will occur at each trimester and 1 virtual follow-up will be done 3 months after delivery for both groups. The total duration of participation for all is approximately 9 months.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Québec, Quebec, Canada, G1V 4G2
      • CHU de Quebec-Universite Laval

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• ≤ 14 gestational weeks;
• Singleton pregnancy;
• At risk of GDM According to Diabetes Canada (being 35 years of age or older or from a high-risk group (African, Arab, Asian, Hispanic, Indigenous, or South Asian) or having a BMI ≥ 30 kg/m2, prediabetes, GDM in a previous pregnancy, given birth to a baby that weighed more than 4 kg, a parent, brother or sister with type 2 diabetes, polycystic ovary syndrome or acanthosis nigricans (darkened patches of skin).

Exclusion Criteria:

• Having a diabetes diagnosis in the 1st trimester;
• Pre-existing diabetes mellitus;
• Diseases requiring active nutritional treatment or influencing glucose metabolism (including previous bariatric surgery);
• Taking part in a nutritional intervention program;
• Corticosteroid use;
• Previous or current diagnosis of an eating disorder;
• Inability to give informed consent;
• Inability to communicate in French.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nutritional Intervention; Intervention promoting healthy eating by a Registered Dietitian.	Behavioral: Nutritional Intervention; 4 individual 1-hour in person (or virtual, according to potential public health restrictions and patients' preference) motivational interviews (12, 18, 24 and 30 weeks) with a registered dietitian will be conducted to elaborate S.M.A.R.T. (Specific,Measurable, Attainable, Relevant, Timely) goals regarding diet, based on the 2019 Canada's Food Guide. Between those individual follow-ups, 4 phone calls with the registered dietitian will be provided (15, 21, 27, 33 weeks). Throughout the study, 10 informative nutritional video clips will also be provided. Participants receiving the intervention will have access to an online Facebook private community to discuss and share experiences, thus maintaining motivation and providing social support.
No Intervention: Standard Care; Women will have their usual medical pregnancy follow-ups by their MDs without access to nutritional care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting plasma glucose	Measured after a 12-hour fast.	Changes from the 1st to the 3rd trimester

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-prandial plasma glucose	Measured 60 and 120 minutes during a 2-hour Oral Glucose Tolerance Test	Changes from the 1st to the 3rd trimester
Glycemic response	Using incremental area under the curve for the blood glucose during a 2-hour Oral Glucose Tolerance Test	Changes from the 1st to the 3rd trimester
Hepatic insulin sensitivity	Homeostasis Model Assessment of Insulin Sensibility	Changes from the 1st to the 3rd trimester
Hepatic and peripheral insulin sensitivity index	Matsuda index	Changes from the 1st to the 3rd trimester
Beta-cell function index	Disposition index: Matsuda index*insulinogenic index	Changes from the 1st to the 3rd trimester
Gestational Diabetes Mellitus diagnosis	Incidence	End of pregnancy

Collaborators and Investigators

• Sponsor: CHU de Quebec-Universite Laval
• Collaborators: Canadian Institutes of Health Research (CIHR); Laval University
• Investigators: Principal Investigator: Anne-Sophie Morisset, RD, PhD, CHU de Quebec-Universite Laval

Publications and helpful links

General Publications

• Bernier E, Plante AS, Lemieux P, Robitaille J, Lemieux S, Desroches S, Belanger-Gravel A, Maheux-Lacroix S, Weisnagel SJ, Demers S, Camirand Lemyre F, Boulet M, Baillargeon JP, Morisset AS. 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2022
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: February 28, 2022
• First Submitted That Met QC Criteria: March 17, 2022
• First Posted (Actual): March 29, 2022

Study Record Updates

• Last Update Posted (Estimated): September 9, 2025
• Last Update Submitted That Met QC Criteria: September 2, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Nutrition; Gestational Diabetes; Healthy Eating
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Female Urogenital Diseases and Pregnancy Complications; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes, Gestational; Pregnancy Complications
• Other Study ID Numbers: 2022-6100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No