Lifestyle Interventions for Gestational Diabetes

Overseen By David M Haas, MD

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: Indiana University

Must not be taking: Metformin, Systemic steroids

Disqualifiers: Multiple gestations, Type 1 or 2 diabetes, Major fetal anomalies, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Throughout pregnancy

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a more intense diet and exercise program, known as the GDM Prevention Program, can better control blood sugar and reduce the risk of developing gestational diabetes (GDM) compared to standard advice. Participants will either follow the regular guidance or join the new, more rigorous program. The trial seeks pregnant women who are less than 16 weeks along and meet specific criteria, such as being 35 or older, having a family history of diabetes, or having a BMI of 30 or higher. As an unphased trial, this study offers participants the chance to contribute to important research that could improve health outcomes for pregnant women.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently taking Metformin or took it within 3 months before conception.

What prior data suggests that this program is safe for gestational diabetes prevention?

Research has shown that lifestyle changes, such as increased exercise and dietary adjustments, are generally safe for pregnant women. These changes have been found to lower the risk of gestational diabetes (GDM), a condition where blood sugar levels are too high during pregnancy.

Studies where participants increased physical activity demonstrated a lower risk of developing GDM. Specifically, exercising more at health clinics reduced the risk by 41% compared to exercising at home. These studies reported no major safety issues, indicating that the changes were well-tolerated.

The GDM Prevention Program in this trial includes a more intensive exercise and monitoring routine. Although the specific results of this program are not yet known, similar past interventions have been shown to be safe. This suggests that participants can expect the treatment to be safe, based on earlier research with similar methods. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the GDM Prevention Program for gestational diabetes because it introduces a more intensive exercise and monitoring approach compared to the standard care of basic diet and exercise counseling. This program is unique because it emphasizes a structured, proactive strategy to prevent gestational diabetes rather than just managing it once diagnosed. By focusing on more rigorous activity and close monitoring, researchers hope to not only manage but also reduce the incidence of gestational diabetes, potentially improving outcomes for both mothers and their babies.

What evidence suggests that the GDM Prevention Program might be an effective treatment for gestational diabetes?

Research has shown that lifestyle changes can help manage and prevent gestational diabetes (GDM). Eating a healthy diet and staying active can lower the risk of developing GDM by 18%. This trial will compare standard care counseling for diet and exercise with a more intensive exercise and monitoring program, known as the GDM Prevention Program. Studies have found that women who followed a structured lifestyle program lost more weight and had better health outcomes than those who did not. Starting this kind of program before pregnancy may reduce the risk of GDM by about 24%. These findings suggest that focused lifestyle changes could help control blood sugar levels and lower the chances of developing GDM. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for pregnant individuals at or before 16 weeks and 6 days, aged 35+, with a family history of diabetes, BMI of 30 or more, or Hemoglobin A1c between 5.9% to 6.4%. It excludes those with major fetal anomalies, multiple gestations, chronic steroid use (except inhaled/short-term), current/pre-pregnancy Type 1/2 diabetes diagnosis, recent Metformin use, or inability to consent in English/Spanish.

Inclusion Criteria

I am pregnant, under 17 weeks, and either over 35, have a family history of diabetes, a BMI of 30 or more, or my A1c is between 5.9% to 6.4%.

Exclusion Criteria

My fetus has been diagnosed with a major anomaly.

Multiple gestations

I have been diagnosed with diabetes, either Type 1 or 2, possibly during this pregnancy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized into either standard care or a more intensive GDM prevention program, involving dietary and activity counseling, wearing activity trackers, and continuous glucose monitoring

Throughout pregnancy

Follow-up

Participants are monitored for safety and effectiveness after treatment, including blood draws to measure hemoglobin A1c, lipids, and HOMA-IR measures

4-6 weeks postpartum

What Are the Treatments Tested in This Trial?

Interventions

• GDM Prevention Program

Trial Overview

The study tests if a high-intensity diet and activity counseling program can better control blood sugar and reduce the risk of developing gestational diabetes compared to standard counseling. Participants will receive different levels of dietary and activity guidance.

How Is the Trial Designed?

Group I: GDM Prevention Program Experimental Treatment 1 Intervention

This arm consists of a more intensive exercise and monitoring program. .

Group II: Control Active Control 1 Intervention

This arm consists of standard of care counseling for diet and exercise.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Northeastern University

Collaborator

Trials

103

Recruited

72,600+

University of Texas

Collaborator

Trials

193

Recruited

143,000+

Published Research Related to This Trial

The study developed reliable and valid measures to assess psychosocial factors influencing physical activity and diet in women with a history of gestational diabetes mellitus (GDM), based on a survey of 160 participants.

These measures demonstrated good internal reliability and construct validity, which will help in evaluating behavior change interventions aimed at promoting healthy lifestyles in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reliability and Validity of Measures for Investigating the Determinants of Health Behaviors Among Women With a History of Gestational Diabetes. Smith, BJ., Cheung, NW., Najnin, N., et al.[2019]

A lifestyle intervention focusing on diet, physical activity, and weight control significantly reduced the incidence of gestational diabetes mellitus (GDM) among high-risk pregnant women, with 281 participants analyzed from a larger group of 1822.

Women who received the lifestyle intervention had a lower risk of adverse maternal outcomes compared to those who only received usual prenatal care, indicating the effectiveness of tailored lifestyle changes during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle intervention to prevent gestational diabetes mellitus and adverse maternal outcomes among pregnant women at high risk for gestational diabetes mellitus. Lin, X., Yang, T., Zhang, X., et al.[2021]

In a study of 251 women at high risk for gestational diabetes mellitus (GDM), lifestyle interventions reduced the risk of GDM by 46.9% and pregnancy-induced hypertension (PIH) by 74.2% compared to a control group.

The interventions improved women's understanding of pregnancy-related health, helped manage weight gain, and prevented metabolic issues, emphasizing the importance of early screening and lifestyle changes for high-risk pregnant women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle interventions to prevent adverse pregnancy outcomes in women at high risk for gestational diabetes mellitus: a randomized controlled trial. Xu, J., Lin, X., Fang, Y., et al.[2023]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/36918133/

Effectiveness of the National Diabetes Prevention Program ...

Conclusions: Diverse younger women with previous gestational diabetes attending the NDPP had one third greater attendance and twice as much weight loss as other ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11032369/

Effective interventions in preventing gestational diabetes ...

The combined diet and physical activity intervention lowered the incidence of GDM by 18% (RR 0.82; 95% CI 0.74, 0.94; I2 = 46%; low-quality ...

3.

dmsjournal.biomedcentral.com

dmsjournal.biomedcentral.com/articles/10.1186/s13098-025-01606-x

Lifestyle intervention to prevent type 2 diabetes after a ...

LSI offered to women with GDM following pregnancy is effective in preventing type 2 diabetes, despite the small postpartum weight change.

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0749379723001307

Effectiveness of the National Diabetes Prevention Program ...

In conclusion, the NDPP appears to be relatively effective for younger women with previous GDM, but more effort is needed to reach younger women ...

5.

nature.com

nature.com/articles/s41387-023-00251-5

Effectiveness of pre-pregnancy lifestyle in preventing ...

Data from RCTs were limited and showed that pre-pregnancy lifestyle interventions may reduce the risk of developing GDM by about 24%. The cohort ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4399293/

The Diabetes Prevention Program Outcomes Study 10 ...

In the initial 3-year intervention period of the DPP, women with a history of GDM had a 71% higher risk of development of diabetes compared with parous women ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11311188/

Development and acceptability of a gestational diabetes ...

GDM has various short-term and long-term risks to pregnant women and their offspring. Hyperglycemia during pregnancy can result in complications ...

8.

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 ...

9.

diabetesjournals.org

diabetesjournals.org/care/article/48/Supplement_1/S306/157565/15-Management-of-Diabetes-in-Pregnancy-Standards

15. Management of Diabetes in Pregnancy: Standards of Care ...

Observational studies in preexisting diabetes and pregnancy show the lowest rates of adverse fetal outcomes in association with A1C <6–6.5% (<42 ...

10.

sciencedirect.com

sciencedirect.com/science/article/pii/S1551714422003330

A randomized controlled trial of a shared decision making ...

Secondary outcomes include the proportion with ≥5% weight loss at 24 months, uptake of an evidence-based diabetes prevention strategy within 6 months, patient- ...