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

150 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Nutritional Intervention for Gestational Diabetes?

Research shows that nutritional therapy is a key part of managing gestational diabetes, helping to control blood sugar levels and improve health outcomes for both mother and baby. Studies indicate that dietary advice and individual diet interventions can lead to better blood glucose control and pregnancy outcomes. ^{1 2 3 4 5}

Is nutritional intervention safe for gestational diabetes?

Nutritional intervention, often used to manage gestational diabetes, is generally considered safe for pregnant women. Studies have shown that it can help control blood sugar levels and improve pregnancy outcomes without significant safety concerns. ^{2 5 6 7 8}

How is the nutritional intervention treatment for gestational diabetes different from other treatments?

Nutritional intervention for gestational diabetes focuses on personalized dietary changes to manage blood sugar levels and support healthy pregnancy weight gain, unlike medication-based treatments that may involve insulin. This approach emphasizes balanced nutrient intake, including specific carbohydrate and fat management, and is often the first line of treatment before considering medication. ^{3 9 10 11 12}

Research Team

Anne-Sophie Morisset, RD, PhD

Principal Investigator

CHU de Québec-Université Laval

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Dietary intakes in the nutritional management of gestational diabetes mellitus. [2019]

2. Australia pubmed.ncbi.nlm.nih.gov

Clinically relevant improvements achieved from a facilitated implementation of a gestational diabetes model of care. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Gestational diabetes and nutritional recommendations. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Dietary recommendations for women with gestational diabetes mellitus: a systematic review of clinical practice guidelines. [2021]

5. China 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. [2021]

6. Poland pubmed.ncbi.nlm.nih.gov

A comparison of the effectiveness, tolerability and safety of high and low carbohydrate diets in women with gestational diabetes. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Impact of gestational diabetes mellitus nutrition practice guidelines implemented by registered dietitians on pregnancy outcomes. [2022]

8. Canada pubmed.ncbi.nlm.nih.gov

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

9. Mexico pubmed.ncbi.nlm.nih.gov

[Physiopathology and nutritional care of patients with gestational diabetes]. [2006]

10. Iran pubmed.ncbi.nlm.nih.gov

Nutrition Therapy in Managing Pregnant Women With Gestational Diabetes Mellitus: A Literature Review. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Medical nutrition therapy and lifestyle interventions. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Nutrient intake of women with and without gestational diabetes with a specific focus on fatty acids. [2017]