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Healthy Eating in Women at Risk of Gestational Diabetes (SAGE)

Primary Purpose

Gestational Diabetes, Pregnancy Complications

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Nutritional Intervention
Sponsored by
CHU de Quebec-Universite Laval
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gestational Diabetes focused on measuring Nutrition, Healthy Eating, Gestational Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • ≤ 12 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 using corticosteroid medication 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 positive GDM 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.

Sites / Locations

  • CHU de Québec-Université LavalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Nutritional Intervention

Standard Care

Arm Description

Intervention promoting healthy eating by a Registered Dietitian.

Women will have their usual medical pregnancy follow-ups by their MDs without access to nutritional care.

Outcomes

Primary Outcome Measures

Fasting plasma glucose
Measured after a 12-hour fast.

Secondary Outcome Measures

Post-prandial plasma glucose
Measured 60 and 120 minutes during a 2-hour Oral Glucose Tolerance Test
Glycemic response
Using incremental area under the curve for the blood glucose during a 2-hour Oral Glucose Tolerance Test
Hepatic insulin sensitivity
Homeostasis Model Assessment of Insulin Sensibility
Hepatic and peripheral insulin sensitivity index
Matsuda index
Beta-cell function index
Disposition index: Matsuda index*insulinogenic index
Gestational Diabetes Mellitus diagnosis
Incidence

Full Information

First Posted
February 28, 2022
Last Updated
August 30, 2023
Sponsor
CHU de Quebec-Universite Laval
Collaborators
Canadian Institutes of Health Research (CIHR), Laval University
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1. Study Identification

Unique Protocol Identification Number
NCT05299502
Brief Title
Healthy Eating in Women at Risk of Gestational Diabetes
Acronym
SAGE
Official Title
Promoting Healthy Eating in Early Pregnancy in Women at Risk of Gestational Diabetes Mellitus: Does it Improve Glucose Homeostasis? A Preliminary Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 30, 2022 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
CHU de Quebec-Universite Laval
Collaborators
Canadian Institutes of Health Research (CIHR), Laval University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 120 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes, Pregnancy Complications
Keywords
Nutrition, Healthy Eating, Gestational Diabetes

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nutritional Intervention
Arm Type
Experimental
Arm Description
Intervention promoting healthy eating by a Registered Dietitian.
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
Women will have their usual medical pregnancy follow-ups by their MDs without access to nutritional care.
Intervention Type
Behavioral
Intervention Name(s)
Nutritional Intervention
Intervention Description
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 Outcome Measure Information:
Title
Fasting plasma glucose
Description
Measured after a 12-hour fast.
Time Frame
Changes from the 1st to the 3rd trimester
Secondary Outcome Measure Information:
Title
Post-prandial plasma glucose
Description
Measured 60 and 120 minutes during a 2-hour Oral Glucose Tolerance Test
Time Frame
Changes from the 1st to the 3rd trimester
Title
Glycemic response
Description
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
Title
Hepatic insulin sensitivity
Description
Homeostasis Model Assessment of Insulin Sensibility
Time Frame
Changes from the 1st to the 3rd trimester
Title
Hepatic and peripheral insulin sensitivity index
Description
Matsuda index
Time Frame
Changes from the 1st to the 3rd trimester
Title
Beta-cell function index
Description
Disposition index: Matsuda index*insulinogenic index
Time Frame
Changes from the 1st to the 3rd trimester
Title
Gestational Diabetes Mellitus diagnosis
Description
Incidence
Time Frame
End of pregnancy

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: ≤ 12 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 using corticosteroid medication 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 positive GDM 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne-Sophie Morisset, RD, PhD
Organizational Affiliation
CHU de Québec-Université Laval
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Québec-Université Laval
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1V 4G2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne-Sophie Plante, RD, MSc
Phone
418-525-4444
Email
anne-sophie.plante@crchudequebec.ulaval.ca

12. IPD Sharing Statement

Plan to Share IPD
No

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Healthy Eating in Women at Risk of Gestational Diabetes

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