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NCT Number: NCT05299502

Healthy Eating in Women at Risk of Gestational Diabetes

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Québec-Université Laval

Québec, Quebec, G1V 4G2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nutritional Intervention

Behavioral

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.

Primary outcomes

  1. Fasting plasma glucose

    Time frame: Changes from the 1st to the 3rd trimester

    Measured after a 12-hour fast.

Secondary outcomes

  1. Post-prandial plasma glucose

    Time frame: Changes from the 1st to the 3rd trimester

    Measured 60 and 120 minutes during a 2-hour Oral Glucose Tolerance Test

  2. Glycemic response

    Time frame: Changes from the 1st to the 3rd trimester

    Using incremental area under the curve for the blood glucose during a 2-hour Oral Glucose Tolerance Test

  3. Hepatic insulin sensitivity

    Time frame: Changes from the 1st to the 3rd trimester

    Homeostasis Model Assessment of Insulin Sensibility

  4. Hepatic and peripheral insulin sensitivity index

    Time frame: Changes from the 1st to the 3rd trimester

    Matsuda index

  5. Beta-cell function index

    Time frame: Changes from the 1st to the 3rd trimester

    Disposition index: Matsuda index*insulinogenic index

  6. Gestational Diabetes Mellitus diagnosis

    Time frame: End of pregnancy

    Incidence

Sponsors and collaborators

Lead sponsor

CHU de Quebec-Universite Laval

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)
  • Laval University

Registry information

Official study title

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

Acronym: SAGE

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Mar 29, 2022
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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