Lifestyle Interventions for Gestational Diabetes

Recruiting in Palo Alto (17 mi)

Age: Any Age

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Indiana University

No Placebo Group

Trial Summary

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.

+4 more

Participant Groups

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.

2Treatment groups

Experimental Treatment

Active Control

Group I: GDM Prevention ProgramExperimental Treatment1 Intervention

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

Group II: ControlActive Control1 Intervention

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