Healthy Eating in Women at Risk of Gestational Diabetes

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05299502
Study type	Interventional
Source	CHU de Quebec-Universite Laval
Contact
Status	Recruiting
Phase	N/A
Start date	June 30, 2022
Completion date	February 2027

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See also
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Completed	`NCT00534105` - Lipid Metabolism in Gestational Diabetes	N/A
Recruiting	`NCT00371306` - Comparison of Glucovance to Insulin for Diabetes During Pregnancy	N/A
Completed	`NCT03388723` - Intergenerational Programming of Diabesity in Offspring of Women With Gestational Diabetes Mellitus
Recruiting	`NCT04521712` - Postpartum Glycemia in Women at Risk For Persistent Hyperglycemia	N/A
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Active, not recruiting	`NCT03301792` - Group Versus Traditional Prenatal Care for Diabetes	N/A
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Healthy Eating in Women at Risk of Gestational Diabetes — SAGE

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms