Healthy Eating in Women at Risk of Gestational Diabetes

NCT05299502 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-09-09

No results posted yet for this 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.

Conditions

  • Gestational Diabetes
  • Pregnancy Complications

Interventions

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.

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV
  • Laval University

    collaborator OTHER
  • CHU de Quebec-Universite Laval

    lead OTHER

Principal Investigators

  • Anne-Sophie Morisset, RD, PhD · CHU de Québec-Université Laval

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-30
Primary Completion
2026-02-28
Completion
2027-02-28

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05299502 on ClinicalTrials.gov