Healthy Eating in Women at Risk of Gestational Diabetes

Gestational Diabetes Clinical Trial

— SAGE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05299502
• Other study ID #: 2022-6100
• Status: Recruiting
• Phase: N/A
• Start date: June 30, 2022
• Est. completion date: February 2027

Study information

• Verified date: October 2023
• Source: CHU de Quebec-Universite Laval
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: February 2027
• Est. primary completion date: February 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes
• Pregnancy Complications

Intervention

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.

Locations

Country	Name	City	State
Canada	CHU de Québec-Université Laval	Québec	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
CHU de Quebec-Universite Laval	Canadian Institutes of Health Research (CIHR), Laval University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting plasma glucose	Measured after a 12-hour fast.	Changes from the 1st to the 3rd trimester
Secondary	Post-prandial plasma glucose	Measured 60 and 120 minutes during a 2-hour Oral Glucose Tolerance Test	Changes from the 1st to the 3rd trimester
Secondary	Glycemic response	Using incremental area under the curve for the blood glucose during a 2-hour Oral Glucose Tolerance Test	Changes from the 1st to the 3rd trimester
Secondary	Hepatic insulin sensitivity	Homeostasis Model Assessment of Insulin Sensibility	Changes from the 1st to the 3rd trimester
Secondary	Hepatic and peripheral insulin sensitivity index	Matsuda index	Changes from the 1st to the 3rd trimester
Secondary	Beta-cell function index	Disposition index: Matsuda index*insulinogenic index	Changes from the 1st to the 3rd trimester
Secondary	Gestational Diabetes Mellitus diagnosis	Incidence	End of pregnancy