Gestational DiabetesSAGENCT05299502
Healthy Eating in Women at Risk of Gestational Diabetes
A study testing Nutritional Intervention in people with Gestational Diabetes and Pregnancy Complications, run by CHU de Quebec-Universite Laval at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes, Pregnancy Complications
- What is being tested?
- Nutritional Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- 30 Jun 2022to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≤ 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Promoting Healthy Eating in Early Pregnancy in Women at Risk of Gestational Diabetes Mellitus: Does it Improve Glucose Homeostasis?
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.
Read the 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.
- Conditions
- Gestational Diabetes, Pregnancy Complications
- Being tested
- Nutritional Intervention
- Keywords
- Nutrition, Healthy Eating, Gestational Diabetes
- Medical subject headings
- Diabetes, Gestational, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Nutritional Intervention | Experimental | Intervention promoting healthy eating by a Registered Dietitian. Receives: Behavioral: Nutritional Intervention |
| Standard Care | No intervention | Women will have their usual medical pregnancy follow-ups by their MDs without access to nutritional care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting plasma glucose
Measured after a 12-hour fast.
Measured: Changes from the 1st to the 3rd trimester
Secondary outcomes (6)
Post-prandial plasma glucose
Measured 60 and 120 minutes during a 2-hour Oral Glucose Tolerance Test
Measured: Changes from the 1st to the 3rd trimester
Glycemic response
Using incremental area under the curve for the blood glucose during a 2-hour Oral Glucose Tolerance Test
Measured: Changes from the 1st to the 3rd trimester
Hepatic insulin sensitivity
Homeostasis Model Assessment of Insulin Sensibility
Measured: Changes from the 1st to the 3rd trimester
Hepatic and peripheral insulin sensitivity index
Matsuda index
Measured: Changes from the 1st to the 3rd trimester
Beta-cell function index
Disposition index: Matsuda index*insulinogenic index
Measured: Changes from the 1st to the 3rd trimester
Gestational Diabetes Mellitus diagnosis
Incidence
Measured: End of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start30 Jun 2022
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Laval University
- Responsible party
- Principal investigator, Anne-Sophie Morisset, CHU de Quebec-Universite Laval
- Investigators
- Anne-Sophie Morisset, RD, PhD, Principal investigator, CHU de Québec-Université Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05299502
- Sponsor's protocol ID
- 2022-6100
- Acronym
- SAGE
- Status last verified
- Sep 2025
- First submitted
- 28 Feb 2022
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bernier E, Plante AS, Lemieux P, Robitaille J, Lemieux S, Desroches S, Belanger-Gravel A, Maheux-Lacroix S, Weisnagel SJ, Demers S, Camirand Lemyre F, Boulet M, Baillargeon JP, Morisset AS. Promoting healthy eating in early pregnancy in individuals at risk of gestational diabetes mellitus: does it improve glucose homeostasis? A study protocol for a randomized control trial. Front Nutr. 2024 Jan 19;10:1336509. doi: 10.3389/fnut.2023.1336509. eCollection 2023.
PubMed 38312142
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Healthy Eating in Early Pregnancy in Women at Risk of Gestational Diabetes Mellitus: Does it Improve Glucose Homeostasis?
- ClinicalTrials.gov ID
- NCT05299502
- Acronym / sponsor ID
- SAGE / 2022-6100
- Conditions
- Gestational Diabetes, Pregnancy Complications
- Keywords
- Nutrition, Healthy Eating, Gestational Diabetes
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Laval University
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 29 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutritional Intervention | Experimental | Behavioral: Nutritional InterventionIntervention promoting healthy eating by a Registered Dietitian. |
| Standard Care | No intervention | –Women will have their usual medical pregnancy follow-ups by their MDs without access to nutritional care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≤ 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).
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional Intervention4 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. | Behavioural | Nutritional Intervention |
Primary outcome
Fasting plasma glucose
Time frame: Changes from the 1st to the 3rd trimester
Measured after a 12-hour fast.
6 secondary outcomes
Post-prandial plasma glucose
Time frame: Changes from the 1st to the 3rd trimester
Glycemic response
Time frame: Changes from the 1st to the 3rd trimester
Hepatic insulin sensitivity
Time frame: Changes from the 1st to the 3rd trimester
Hepatic and peripheral insulin sensitivity index
Time frame: Changes from the 1st to the 3rd trimester
Beta-cell function index
Time frame: Changes from the 1st to the 3rd trimester
Gestational Diabetes Mellitus diagnosis
Time frame: End of pregnancy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Derived from this study: PubMed 38312142Bernier E, Plante AS, Lemieux P, Robitaille J, Lemieux S, Desroches S, Belanger-Gravel A, Maheux-Lacroix S, Weisnagel SJ, Demers S, Camirand Lemyre F, Boulet M, Baillargeon JP, Morisset AS. Promoting healthy eating in early pregnancy in individuals at risk of gestational diabetes mellitus: does it improve glucose homeostasis? A study protocol for a randomized control trial. Front Nutr. 2024 Jan 19;10:1336509. doi: 10.3389/fnut.2023.1336509. eCollection 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne-Sophie Morisset, RD, PhD principal investigator
CHU de Québec-Université Laval
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional Intervention in people with Gestational Diabetes and Pregnancy Complications, run by CHU de Quebec-Universite Laval at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting plasma glucose (time frame: Changes from the 1st to the 3rd trimester). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05299502, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.