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Clinical Trials in Canada / NCT05299502
Active, not recruiting Not applicable

Healthy Eating in Women at Risk of Gestational Diabetes

NCT05299502 · tracked via the Priya Life Science Canada tracker
Phase
Not applicable
Started
2022-06-30
Last updated
2025-09-09

Condition(s) studied

Gestational DiabetesPregnancy Complications

Investigational drug(s) / intervention(s)

Nutritional Intervention

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.

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
CHU de Québec-Université Laval Québec Quebec

More CHU de Quebec-Universite Laval trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05299502 on ClinicalTrials.gov ↗ ← All trials in Canada