NCT05299502

Healthy Eating in Women at Risk of Gestational Diabetes

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: CHU de Quebec-Universite Laval · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

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.

Conditions

• Gestational Diabetes
• Pregnancy Complications

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-06-30
• Primary completion: 2026-02-01
• Completion: 2027-02-01
• First posted: 2022-03-29
• Last updated: 2025-09-09

Locations

1 site across 1 country: Canada