Nutritional Intervention for Gestational Diabetes

(SAGE Trial)

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: CHU de Quebec-Universite Laval

Must not be taking: Corticosteroids

Disqualifiers: Diabetes, Bariatric surgery, Eating disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adopting healthy eating habits early in pregnancy can help manage blood sugar levels and reduce the risk of gestational diabetes, a type of diabetes that occurs during pregnancy. Participants will either receive personalized nutritional guidance from a dietitian (nutritional intervention) or continue with their usual care without extra dietary support. The study seeks pregnant women in their first trimester who are at risk for gestational diabetes, including those with a family history of diabetes or certain ethnic backgrounds.

As an unphased trial, this study offers participants the chance to contribute to important research that could improve pregnancy health outcomes.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude those using corticosteroids. It's best to discuss your specific medications with the trial coordinators.

What prior data suggests that this nutritional intervention is safe for pregnant women?

Research has shown that dietary changes to manage gestational diabetes are generally safe for pregnant women. Studies have found that these changes can control blood sugar levels without causing harm. For instance, a review of several studies found that consuming foods with a low glycemic index (GI) can reduce the risk of having a larger-than-average baby in women with gestational diabetes. This indicates that a well-planned diet can have positive effects without negative side effects.

Additionally, research suggests that certain diets, such as the DASH diet—which includes plenty of fruits, vegetables, and low-fat dairy—benefit both mother and baby during pregnancy. These diets are easy to follow and have been successfully used to manage gestational diabetes, making them a safe choice for those considering participation in a nutrition-focused trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard care for gestational diabetes, which typically involves monitoring blood sugar and sometimes medication, the nutritional intervention in this trial focuses on promoting healthy eating habits guided by a Registered Dietitian. This approach aims to manage gestational diabetes through dietary changes rather than relying solely on medication. Researchers are excited about this because it empowers pregnant women to take control of their health through personalized nutrition, potentially reducing the need for medication and improving outcomes for both the mother and baby.

What evidence suggests that this nutritional intervention might be an effective treatment for gestational diabetes?

This trial will compare a Nutritional Intervention with Standard Care for managing gestational diabetes mellitus (GDM). Research has shown that dietary changes can help manage GDM. One study found that dietary adjustments lowered the risk of GDM by 27%, highlighting a strong link between diet and diabetes prevention. Another study found that certain diets, such as the DASH diet, reduced complications like the need for cesarean sections. Additionally, nutritional therapy, which participants in this trial may receive, has been shown to help control blood sugar levels and improve the quality of life for pregnant women with GDM. These findings suggest that starting a healthy diet early in pregnancy can help manage blood sugar levels. ^{3 6 7 8 9}

Who Is on the Research Team?

Anne-Sophie Morisset, RD, PhD

Principal Investigator

CHU de Québec-Université Laval

Are You a Good Fit for This Trial?

This trial is for pregnant women under 14 weeks gestation, at risk of gestational diabetes due to factors like age (35+), certain ethnic backgrounds, high BMI (≥30 kg/m2), or a family history of type 2 diabetes. Women with eating disorders, pre-existing diabetes, other diseases affecting glucose metabolism, or on steroids can't join.

Inclusion Criteria

I am 14 weeks pregnant or less.

I am at risk of gestational diabetes due to my age, ethnicity, BMI, medical or family history.

You are pregnant with one baby.

Exclusion Criteria

I have diabetes.

I cannot communicate in French.

I have a condition that affects my blood sugar or requires special diet treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Nutritional Intervention

Participants receive a nutritional intervention promoting healthy eating by a Registered Dietitian, starting in the first trimester, with 4 individual sessions at 12, 18, 24, and 30 weeks.

18 weeks

4 visits (in-person), additional virtual support

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a virtual follow-up 3 months after delivery.

3 months

1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Nutritional Intervention

Trial Overview The study tests if starting a healthy eating program early in pregnancy can improve blood sugar control and reduce the risk of gestational diabetes. It involves dietitian sessions and support through web capsules and a private Facebook group compared to standard care.

How Is the Trial Designed?

Group I: Nutritional Intervention Experimental Treatment 1 Intervention

Intervention promoting healthy eating by a Registered Dietitian.

Group II: Standard Care Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

CHU de Quebec-Universite Laval

Lead Sponsor

Trials

177

Recruited

110,000+

Laval University

Collaborator

Trials

439

Recruited

178,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Published Research Related to This Trial

The implementation of a structured model of care for gestational diabetes in regional Australian sites significantly increased the proportion of women receiving best practice nutrition therapy from 3.5% to 87.8% at Site 1, demonstrating the efficacy of the approach.

Despite challenges such as organizational barriers, the project successfully reduced the number of women requiring medication for gestational diabetes, indicating improved management of the condition through enhanced support and resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinically relevant improvements achieved from a facilitated implementation of a gestational diabetes model of care. Wilkinson, SA., McCray, SJ., Kempe, A., et al.[2019]

A clinical trial involving 215 women with gestational diabetes showed that following specific nutrition practice guidelines led to less insulin use and better control of glycated hemoglobin levels in diabetes clinic settings compared to usual care.

Women receiving care under the nutrition practice guidelines had a lower proportion of elevated glycated hemoglobin levels (8.1%) compared to those in the usual care group (13.6%), suggesting that these guidelines may improve management of gestational diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of gestational diabetes mellitus nutrition practice guidelines implemented by registered dietitians on pregnancy outcomes. Reader, D., Splett, P., Gunderson, EP.[2022]

Maintaining proper glycemic control during pregnancy is crucial to reduce risks such as diabetes in mothers and macrosomia in infants, with diet therapy being the first line of treatment, and insulin therapy sometimes necessary for adequate control.

Nutrition therapy, which includes personalized meal planning and education on carbohydrate intake, is essential in managing gestational diabetes and should be delivered by a multidisciplinary team to ensure comprehensive care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Physiopathology and nutritional care of patients with gestational diabetes]. Perichart Perera, O., Alonso de la Vega, P., Ortega González, C.[2006]

Nutrition therapy is essential for managing gestational diabetes mellitus (GDM), and guidelines have been developed by leading organizations to provide evidence-based recommendations for pregnant women with GDM.

While it is recognized that nutrition needs during pregnancy are similar for women with and without diabetes, there is still limited evidence supporting specific nutrition practices for GDM, highlighting the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recommendations for nutrition best practice in the management of gestational diabetes mellitus. Executive summary (1). [2007]

Medical nutrition therapy is essential for managing gestational diabetes mellitus (GDM), focusing on meeting the nutritional needs of both mother and fetus while maintaining optimal blood sugar levels.

Current guidelines recommend a balanced diet for women with GDM, but there is still debate over the best dietary compositions and weight management strategies, highlighting the need for further research to optimize treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gestational diabetes and nutritional recommendations. Gunderson, EP.[2019]

Nutritional management and physical activity are essential first-line treatments for gestational diabetes mellitus (GDM), focusing on regulating maternal blood sugar levels and promoting healthy fetal growth.

Dietary interventions, including the use of supplements, are crucial for improving metabolic profiles in pregnant women with GDM, highlighting the need for ongoing research to further reduce complications for both mothers and their babies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition Therapy in Managing Pregnant Women With Gestational Diabetes Mellitus: A Literature Review. Dolatkhah, N., Hajifaraji, M., Shakouri, SK.[2020]

Proper nutrient intake is crucial for pregnant women with gestational diabetes mellitus (GDM) to achieve good glucose control, appropriate weight gain, and overall health outcomes.

Medical nutrition therapy, combined with education and support, is essential for managing GDM, as it helps women make necessary lifestyle changes that can reduce their risk of developing type 2 diabetes later on.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medical nutrition therapy and lifestyle interventions. Reader, DM.[2022]

In a study of 30 women with gestational diabetes, both low and high carbohydrate diets were found to be effective and safe for managing blood glucose levels, with no ketonuria observed in either group.

The low carbohydrate diet led to significant reductions in post-meal glucose levels, particularly after breakfast, suggesting it may be more beneficial for women experiencing high glucose spikes after meals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of the effectiveness, tolerability and safety of high and low carbohydrate diets in women with gestational diabetes. Cypryk, K., Kamińska, P., Kosiński, M., et al.[2022]

The nutritional intervention for women with gestational diabetes mellitus (GDM) led to a significant reduction in total energy intake and carbohydrate consumption, resulting in lower values compared to women with normal glucose tolerance.

The intervention helped women with GDM maintain a weight gain rate within the recommended limits, while control participants exceeded these limits, indicating the effectiveness of the dietary counseling provided.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary intakes in the nutritional management of gestational diabetes mellitus. Morisset, AS., Côté, JA., Michaud, A., et al.[2019]

A systematic review of 31 clinical practice guidelines for managing gestational diabetes mellitus (GDM) found that 68% were of low quality, primarily due to a lack of editorial independence, highlighting a need for improved guideline development.

While all guidelines recommended dietary advice as the first-line treatment for GDM, the recommendations varied significantly and were often based on low-quality evidence, indicating a critical need for high-quality research to strengthen the evidence base.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary recommendations for women with gestational diabetes mellitus: a systematic review of clinical practice guidelines. Mustafa, ST., Hofer, OJ., Harding, JE., et al.[2021]

Women with gestational diabetes mellitus (GDM) who received individualized dietary counseling significantly reduced their intake of energy, refined sugars, and unhealthy fats compared to non-diabetic women, indicating effective dietary management.

The counseling also led to an increase in beneficial fatty acids like docosahexaenoic acid, which is important for insulin resistance and fetal development, although overall omega-3 intake remained below recommended levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrient intake of women with and without gestational diabetes with a specific focus on fatty acids. Thomas, B., Ghebremeskel, K., Lowy, C., et al.[2017]

A study involving 817 pregnant women with gestational diabetes mellitus (GDM) found that an Individual Diet Intervention (IDI) significantly improved blood glucose control compared to routine care, as indicated by lower glycated hemoglobin (HbA1c) levels.

The IDI also reduced the incidence of cesarean sections and macrosomia (large babies) in the study group, suggesting it may help prevent adverse pregnancy outcomes associated with GDM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of individual dietary intervention on blood glucose level and pregnancy outcomes in patients with gestational diabetes mellitus: a retrospective cohort study. Zhou, S., Wang, L., Chen, J., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9185033/

Clinical efficacy of nutritional diet therapy on gestational ... This study found that the nutritional diet therapy can reduce complications, control glucose sugar, and improve the quality of life of pregnant women with GDM.

2. nature.com nature.com/articles/s43856-024-00491-1

Effective interventions in preventing gestational diabetes ... Dietary intervention reduced GDM by 27% (RR 0.73; 95% CI; 0.61, 0.86; I2 = 31.03%; moderate quality evidence) (Fig. 3). According to Egger's ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2161831324001649

Effects of Dietary Approaches and Exercise Interventions ... Our findings suggest that the DASH diet and low GI diet, and resistance exercise may be beneficial for maternal outcomes in pregnancies with GDM.

4. frontiersin.org frontiersin.org/journals/endocrinology/articles/10.3389/fendo.2025.1512493/full

Comparative efficacy of dietary interventions for glycemic ... Both the DASH and Low-GI diets significantly reduced adverse pregnancy outcomes. Specifically, the DASH diet significantly reduced the risk of cesarean section ...

5. dmsjournal.biomedcentral.com dmsjournal.biomedcentral.com/articles/10.1186/s13098-023-01217-4

Interventions in preconception and pregnant women at risk of ... The findings from the meta-analysis showed that GDM was reduced using combined diet and PA, inositol and vitamin D supplementation in women ...

6. nature.com nature.com/articles/s41591-024-03356-1

Reduced-energy diet in women with gestational diabetes Reduced-energy diets promote weight loss and improve long-term outcomes in type 2 diabetes but are untested in gestational diabetes.

7. andeal.org andeal.org/vault/pq150.pdf

Gestational Diabetes Below are the major recommendations and ratings for the Academy of Nutrition and Dietetics Gestational Diabetes Mellitus. (GDM) Evidence-Based Nutrition ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8616668/

An Update of Medical Nutrition Therapy in Gestational ... Recently, a meta-analysis highlighted that the risk for fetal macrosomia was reduced in pregnant women with GDM who had a diet based on low GI ...

9. withpower.com withpower.com/trial/phase-diabetes-gestational-2-2022-6c5b5

Nutritional Intervention for Gestational Diabetes (SAGE Trial) Nutritional intervention, often used to manage gestational diabetes, is generally considered safe for pregnant women. Studies have shown that it can help ...