Clinical trial NCT05299502: Healthy Eating in Women at Risk of Gestational Diabetes
Official title: Promoting Healthy Eating in Early Pregnancy in Women at Risk of Gestational Diabetes Mellitus: Does it Improve Glucose Homeostasis?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gestational Diabetes
Pregnancy Complications
Keywords: Nutrition
Healthy Eating
Gestational Diabetes
Lead sponsor: CHU de Quebec-Universite Laval
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Laval University
First posted: 2022-03-29
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility 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.

Primary outcomes:
measure: Fasting plasma glucose
timeFrame: Changes from the 1st to the 3rd trimester
Secondary outcomes:
measure: Post-prandial plasma glucose
timeFrame: Changes from the 1st to the 3rd trimester
measure: Glycemic response
timeFrame: Changes from the 1st to the 3rd trimester
measure: Hepatic insulin sensitivity
timeFrame: Changes from the 1st to the 3rd trimester
measure: Hepatic and peripheral insulin sensitivity index
timeFrame: Changes from the 1st to the 3rd trimester
measure: Beta-cell function index
timeFrame: Changes from the 1st to the 3rd trimester
measure: Gestational Diabetes Mellitus diagnosis
timeFrame: End of pregnancy
Other outcomes:
Locations:
city: Québec
country: Canada
facility: CHU de Québec-Université Laval
state: Quebec
Study officials:
affiliation: CHU de Québec-Université Laval
name: Anne-Sophie Morisset, RD, PhD
role: PRINCIPAL_INVESTIGATOR
References: