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?

This trial aims to determine if a specific exercise and diet plan can help pregnant women in cities reduce their risk of diabetes and obesity, while also benefiting their babies. Participants will either join a lifestyle program with exercise and dietary education or be part of a group with no intervention. Pregnant women less than 20 weeks along, who are interested and willing to join, might be suitable candidates. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance health outcomes for mothers and babies.

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.

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

Research shows that exercise and learning about healthy eating during pregnancy are generally safe for both mothers and their babies. Studies have found that lifestyle changes can help prevent gestational diabetes, a type of diabetes that can develop during pregnancy, especially in women at high risk. One study discovered that diets like DASH (which includes plenty of fruits, vegetables, and low-fat dairy) and low GI (which involves slowly digested carbs), along with resistance exercise, benefit pregnant women.

Strong evidence indicates that exercise may reduce the risk of developing gestational diabetes and can lead to better outcomes during pregnancy. These lifestyle changes, often provided through apps or online platforms, have shown positive results in preventing gestational diabetes in pregnant women who are overweight or obese.

Overall, exercise and dietary changes are well-received and beneficial for pregnant women. The reviewed studies identified no major safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using diet and exercise for managing gestational diabetes because these methods focus on lifestyle changes rather than medications, which is the usual approach. Most treatments for gestational diabetes involve insulin or other drugs to control blood sugar levels. However, this lifestyle intervention could help manage the condition naturally by encouraging healthier eating habits and regular physical activity. This approach might reduce the need for medication, minimizing potential side effects for both the mother and baby. Plus, adopting these changes can have long-term health benefits beyond pregnancy.

What evidence suggests that this exercise and dietary education is effective for reducing the risk of obesity and diabetes in mothers and their children?

Research has shown that lifestyle changes during pregnancy can help prevent gestational diabetes (GDM). One study found that these changes reduced the risk of developing GDM by 39% and helped women gain about 0.58 kg less weight during pregnancy. In this trial, participants in the intervention arm will receive exercise and dietary education, including strategies like the DASH diet and low glycemic index diets, along with strength exercises. Exercise, in particular, significantly lowered the risk of GDM. These findings suggest that exercise and dietary changes can enhance pregnancy health and reduce risks for both mothers and their babies. ^{1 2 6 7 8}

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

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]

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 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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10672732/

Effectiveness of Lifestyle Interventions during Pregnancy on ... Conclusions: The results of this study support the efficacy of lifestyle interventions during pregnancy for preventing GDM in high-risk women if an exercise ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7756044/

Lifestyle intervention to prevent gestational diabetes ... The intervention reduced the incidence of GDM by 39% and decreased gestational weight gain (GWG) by 0.58 kg in pregnant women at high risk for GDM; however, ...

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

Effective interventions in preventing gestational diabetes ... Physical activity interventions delivered at healthcare facilities reduce the risk of GDM (RR 0.59; 95% CI 0.49, 0.72) compared with home-based ...

5. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/10.1111/ajo.70032

Pre‐Pregnancy Diet and/or Physical Activity Interventions for ... Pre-pregnancy diet and/or physical activity interventions were not associated with a significant difference in rates of GDM (2 studies; n = 214; ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT00728377

An Exercise Intervention to Prevent Gestational Diabetes | ... The application is innovative in being the first, to our knowledge, to test a physical activity intervention designed to prevent GDM among high risk women. The ...

7. bmcpregnancychildbirth.biomedcentral.com bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-024-07021-w

A systematic review and meta-analysis of exercise-based ... There is evidence that exercise may reduce the risk of gestational diabetes mellitus (GDM) and improve other obstetric outcomes in ...

8. mhealth.jmir.org mhealth.jmir.org/2024/1/e49373

Effects of mHealth-Based Lifestyle Interventions on ... Conclusions: mHealth-based lifestyle interventions had a favorable impact on the prevention of GDM in pregnant women with overweight and obesity ...