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

100 Participants Needed

Trial Summary

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 data supports the effectiveness of the GDM Prevention Program treatment for gestational diabetes?

Research shows that lifestyle interventions, which include changes in diet and physical activity, can help prevent gestational diabetes and reduce the risk of developing Type 2 diabetes later. These interventions have been found to be feasible and potentially effective, especially when delivered by trained facilitators. ^{1 2 3 4 5}

Is the lifestyle intervention for gestational diabetes safe for humans?

Lifestyle interventions, which include changes in diet, physical activity, and behavior, have been tested in various studies and are generally considered safe for humans. These interventions have been used to manage weight and reduce the risk of developing diabetes and other health issues, with no significant safety concerns reported. ^{4 6 7 8 9}

How is the GDM Prevention Program treatment different from other treatments for gestational diabetes?

The GDM Prevention Program is unique because it focuses on lifestyle changes, such as diet and physical activity, to prevent gestational diabetes, rather than relying on medication. This approach aims to help women manage their weight and health behaviors before, during, and between pregnancies to reduce the risk of developing gestational diabetes. ^{1 2 9 10 11}

What is the purpose of this trial?

The goal of this study is assess the impact of a higher intensity dietary and activity counseling program to improve blood sugar control and reduce the chance of developing gestational diabetes (GDM) as compared to the current standard diet and activity counseling.

Eligibility Criteria

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 using steroids for more than 2 weeks before pregnancy.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

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

Systematic Review of Lifestyle Interventions for Gestational Diabetes Mellitus in Pregnancy and the Postpartum Period. [2023]

2. United States 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. [2019]

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

Lifestyle Intervention in Danish Obese Pregnant Women With Early Gestational Diabetes Mellitus According to WHO 2013 Criteria Does Not Change Pregnancy Outcomes: Results From the LiP (Lifestyle in Pregnancy) Study. [2018]

4. England 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. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Lifestyle intervention programme for Indian women with history of gestational diabetes mellitus. [2022]

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

Windows of Opportunity for Lifestyle Interventions to Prevent Gestational Diabetes Mellitus. [2018]

7. Switzerland 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. [2023]

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

Mothers after Gestational Diabetes in Australia (MAGDA): A Randomised Controlled Trial of a Postnatal Diabetes Prevention Program. [2022]

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

Gestational Diabetes Mellitus Can Be Prevented by Lifestyle Intervention: The Finnish Gestational Diabetes Prevention Study (RADIEL): A Randomized Controlled Trial. [2022]

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

Prevention of Gestational Diabetes: The Role of Dietary Intake, Physical Activity, and Weight before, during, and between Pregnancies. [2021]

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

Results From a European Multicenter Randomized Trial of Physical Activity and/or Healthy Eating to Reduce the Risk of Gestational Diabetes Mellitus: The DALI Lifestyle Pilot. [2022]