Diet and Exercise for Gestational Diabetes

(IDEA Trial)

Overseen By Garry Shen, MD, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Manitoba

Disqualifiers: Hypertension, Diabetes, Multiple gestations, 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: Unknown

1000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The general goal of the present study is to assess the impact of a community-based exercise and dietary intervention in pregnant women living in urban areas during and after their pregnancy on the reduction of the risks of both diabetes and obesity in mothers and their offspring. We hypothesize that a community-based lifestyle intervention program during and after gestation may improve pregnancy outcomes in terms of reducing the risk of developing obesity or type 2 DM in mothers and their children.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

Is diet and exercise safe for managing gestational diabetes?

Research shows that diet and exercise interventions for gestational diabetes are generally safe for both mothers and babies, with no significant differences in delivery type, infant birth weight, or other major health outcomes. ^{1 2 3 4 5}

How does the treatment of exercise and dietary education differ from other treatments for gestational diabetes?

This treatment focuses on lifestyle changes, combining exercise and dietary education to manage gestational diabetes, which is different from medication-based approaches. It emphasizes personalized nutrition education and physical activity, aiming to improve blood sugar control and reduce weight gain during pregnancy. ^{1 4 6 7 8}

What data supports the effectiveness of the treatment Exercise and dietary education, Lifestyle Intervention, Dietary Counseling, Physical Activity Intervention for gestational diabetes?

Research shows that combining diet with moderate exercise can significantly improve outcomes for pregnant women with gestational diabetes and their babies. Studies indicate that these non-medical strategies help manage blood sugar levels and reduce complications. ^{1 3 4 9 10}

Who Is on the Research Team?

Garry Shen, MD PhD

Principal Investigator

University of Manitoba

Are You a Good Fit for This Trial?

This trial is for pregnant women living in urban areas, less than 20 weeks into their pregnancy, who are interested in participating. It's not for those with multiple pregnancies, pre-existing diabetes (except past gestational diabetes), or medical reasons that make exercise unsafe during pregnancy.

Inclusion Criteria

I am pregnant and less than 20 weeks along.

I am interested and willing to participate in the study.

Exclusion Criteria

You are pregnant with more than one baby.

You have certain medical conditions during pregnancy that make it unsafe for you to exercise, according to specific guidelines.

You have diabetes that existed before the start of this study, except if you had gestational diabetes during a previous pregnancy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a community-based exercise and dietary intervention during pregnancy

During pregnancy

Postpartum Intervention

Continuation of lifestyle intervention after pregnancy to assess impact on obesity and diabetes risk

After pregnancy

Follow-up

Participants are monitored for safety and effectiveness after the intervention

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Exercise and dietary education

Trial Overview The study tests a community-based program focusing on exercise and diet education to see if it can reduce the risk of obesity and type 2 diabetes in mothers and their children after birth.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Lifestyle intervention

Group II: Control Active Control 1 Intervention

No intervention

Who Is Running the Clinical Trial?

University of Manitoba

Lead Sponsor

Trials

628

Recruited

209,000+

The Lawson Foundation

Collaborator

Trials

16

Recruited

4,000+

Public Health Agency of Canada (PHAC)

Collaborator

Trials

51

Recruited

101,000+

Published Research Related to This Trial

The review presents intervention protocols for managing gestational diabetes, focusing on medical nutritional therapy, weight management, insulin prescriptions, and exercise programs to achieve normoglycemia.

The primary goal of these interventions is to minimize the risk of complications for both the mother and fetus, emphasizing the importance of maintaining healthy blood sugar levels during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

American Diabetes Association's Fourth International Workshop-Conference on Gestational Diabetes Mellitus: summary and discussion. Therapeutic interventions. Jovanovic, L.[2018]

In a pilot study involving 43 women with gestational diabetes, those on a very low energy diet (VLED) gained significantly less weight (5.9 kg) compared to those on a low energy diet (LED) who gained 12.0 kg, suggesting that VLED may be more effective for managing weight during pregnancy.

Both VLED and LED resulted in similar maternal and infant outcomes, with a low incidence of complications and a majority of infants being appropriate-for-gestational age, indicating that either diet can be safely used in managing gestational diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

TIMER: A Clinical Study of Energy Restriction in Women with Gestational Diabetes Mellitus. Tsirou, E., Grammatikopoulou, MG., Nigdelis, MP., et al.[2021]

Combined diet and exercise interventions are effective in preventing gestational diabetes mellitus, as reviewed in the Cochrane Database of Systematic Reviews.

The review highlights the importance of lifestyle modifications during pregnancy, suggesting that these interventions can significantly reduce the risk of developing gestational diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a combined diet and exercise intervention on gestational diabetes. [2018]

In a study involving 200 women with gestational diabetes mellitus (GDM), a simple exercise program significantly reduced postprandial glucose levels, glycated hemoglobin (HbA1c), triglycerides, and C-reactive protein, while not affecting fasting glucose levels.

The exercise intervention also led to a reduction in maternal and neonatal complications, highlighting its efficacy as a beneficial strategy for managing GDM compared to dietary recommendations alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Simple lifestyle recommendations and the outcomes of gestational diabetes. A 2 × 2 factorial randomized trial. Bo, S., Rosato, R., Ciccone, G., et al.[2022]

Non-medical strategies, such as diet, moderate exercise, self-monitoring of blood glucose, and individualized health education, significantly improve pregnancy outcomes for women with gestational diabetes mellitus (GDM), according to a review of 15 studies published between 2005-2015.

The review highlights the importance of early detection and proactive management of GDM, suggesting that future research should focus on enhancing adherence to these healthy behaviors to further improve maternal and neonatal health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-Medical Strategies to Improve Pregnancy Outcomes of Women with Gestational Diabetes Mellitus: A literature review. Al Hashmi, I., Nandy, K., Seshan, V.[2020]

A low-glycemic diet combined with low-volume exercise during pregnancy can significantly reduce insulin resistance, leading to lower blood glucose levels and decreased maternal weight gain, which may help prevent gestational diabetes.

Regular weight-bearing exercise alone also lowers insulin resistance and blood glucose levels during pregnancy, suggesting that both dietary and physical activity interventions are beneficial for at-risk women and those with gestational diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Diet and Exercise on Insulin Resistance during Pregnancy. Clapp, JF.[2022]

The study involved 59 women with recent gestational diabetes and aimed to evaluate a diabetes risk reduction intervention, which successfully improved dietary habits, including energy and fat intake.

Despite the positive changes in diet, the intervention did not lead to increased physical activity, and recruitment for the study was more difficult than anticipated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigation of a lifestyle change strategy for high-risk women with a history of gestational diabetes. Smith, BJ., Cinnadaio, N., Cheung, NW., et al.[2022]

A scoping review of 12 studies on nutrition-education interventions for gestational diabetes showed that both general and personalized nutrition strategies can effectively manage high blood sugar levels during pregnancy.

The review highlighted that while diabetes self-management education varied in content, medical nutrition therapy was more consistent, indicating a need for standardized approaches in nutrition education for gestational diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition-Education-Based Interventions in Gestational Diabetes: A Scoping Review of Clinical Trials. Helm, MM., Izuora, K., Basu, A.[2023]

In a study of 96 obese pregnant women with gestational diabetes, those who followed a weight-gain restriction regimen with exercise (ED group) experienced significantly lower weekly weight gain compared to those on a diet alone (D group), suggesting that combining diet with exercise can effectively manage weight during pregnancy.

Both groups had similar pregnancy outcomes, but the ED group had fewer macrosomic infants (larger than average babies), indicating that weight management through caloric restriction and exercise may lead to healthier birth outcomes without adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A lifestyle intervention of weight-gain restriction: diet and exercise in obese women with gestational diabetes mellitus. Artal, R., Catanzaro, RB., Gavard, JA., et al.[2022]

A 12-week randomized controlled trial with 38 women showed that dietary counseling focusing on whole berries and leafy vegetables significantly improved metabolic health in those with gestational diabetes mellitus (GDM), including better blood glucose levels and increased antioxidant capacity.

The study suggests that incorporating specific functional foods, like berries and leafy vegetables, into the diet can effectively manage GDM and should be recommended as part of treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of an Eating Pattern Including Colorful Fruits and Vegetables on Management of Gestational Diabetes: A Randomized Controlled Trial. Jaworsky, K., DeVillez, P., Alexander, JM., et al.[2023]

Citations

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

American Diabetes Association's Fourth International Workshop-Conference on Gestational Diabetes Mellitus: summary and discussion. Therapeutic interventions. [2018]

2. Switzerland pubmed.ncbi.nlm.nih.gov

TIMER: A Clinical Study of Energy Restriction in Women with Gestational Diabetes Mellitus. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Impact of a combined diet and exercise intervention on gestational diabetes. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Simple lifestyle recommendations and the outcomes of gestational diabetes. A 2 × 2 factorial randomized trial. [2022]

5. Oman pubmed.ncbi.nlm.nih.gov

Non-Medical Strategies to Improve Pregnancy Outcomes of Women with Gestational Diabetes Mellitus: A literature review. [2020]

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

Effects of Diet and Exercise on Insulin Resistance during Pregnancy. [2022]

7. Ireland pubmed.ncbi.nlm.nih.gov

Investigation of a lifestyle change strategy for high-risk women with a history of gestational diabetes. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Nutrition-Education-Based Interventions in Gestational Diabetes: A Scoping Review of Clinical Trials. [2023]

9. Canada pubmed.ncbi.nlm.nih.gov

A lifestyle intervention of weight-gain restriction: diet and exercise in obese women with gestational diabetes mellitus. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of an Eating Pattern Including Colorful Fruits and Vegetables on Management of Gestational Diabetes: A Randomized Controlled Trial. [2023]