CHU de Québec-Université Laval
Québec, Quebec, G1V 4G2, Canada
NCT Number: NCT05299502
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
Female
Interventional
Not applicable
Québec, Quebec, G1V 4G2, Canada
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Changes from the 1st to the 3rd trimester
Measured after a 12-hour fast.
Time frame: Changes from the 1st to the 3rd trimester
Measured 60 and 120 minutes during a 2-hour Oral Glucose Tolerance Test
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
Time frame: Changes from the 1st to the 3rd trimester
Homeostasis Model Assessment of Insulin Sensibility
Time frame: Changes from the 1st to the 3rd trimester
Matsuda index
Time frame: Changes from the 1st to the 3rd trimester
Disposition index: Matsuda index*insulinogenic index
Time frame: End of pregnancy
Incidence
CHU de Quebec-Universite Laval
Other
Promoting Healthy Eating in Early Pregnancy in Women at Risk of Gestational Diabetes Mellitus: Does it Improve Glucose Homeostasis?
Acronym: SAGE
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.
Published trials that share one or more normalized conditions with this study.
NCT06963528
Birth Hypoxia, Birth Outcome, Adverse
Oxford, United Kingdom
View Trial DetailsNCT06814509
Body Weight, Body Weight Changes
Corning, Arkansas, United States
View Trial DetailsNCT07565727
Cardiometabolic Diseases, Diabetes Mellitus
Knoxville, Tennessee, United States
View Trial DetailsNCT06445270
Diabetes Mellitus, Diabetes, Gestational
Indianapolis, Indiana, United States
View Trial Details