Promoting healthy eating in pregnant 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?
This study is testing if a special nutrition program for pregnant women at risk of gestational diabetes can help them manage their blood sugar better than standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | CHU de Quebec-Universite Laval Academic / other |
| Locations | 1 site (Québec, Quebec) |
| Trial ID | NCT05299502 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates whether initiating a nutritional intervention at the beginning of pregnancy can improve glucose homeostasis in women at risk of gestational diabetes mellitus (GDM). A total of 150 pregnant women will be randomized into two groups: one receiving the nutritional intervention based on Canada's Food Guide and the other receiving standard care. The intervention includes four sessions with a registered dietitian and follow-ups to assess diet quality and glucose tolerance through oral glucose tests. Participants will be monitored throughout their pregnancy and three months postpartum to evaluate the effectiveness of the intervention.
Who should consider this trial
Good fit: Ideal candidates are pregnant women under 14 weeks gestation who are at risk of gestational diabetes due to age, BMI, or family history.
Not a fit: Patients diagnosed with diabetes in the first trimester or those with pre-existing diabetes mellitus will not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the risk of gestational diabetes and improve maternal and fetal health outcomes.
How similar studies have performed: Previous studies have shown that early nutritional interventions can positively impact glucose tolerance, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Québec, Quebec
- CHU de Québec-Université Laval — Québec, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Anne-Sophie Morisset, RD, PhD — CHU de Québec-Université Laval
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.