An interventional study of GDM Prevention Program in Gestational Diabetes and Pregnancy Complications, sponsored by Indiana University. Withdrawn at 1 site in United States. Open to female participants aged 14 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by Indiana University · Not applicable, Interventional, and Prevention
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.
GDM is associated with adverse maternal and newborn outcomes, as well as potential lifelong consequences. Currently, clinical guidelines recommend screening for pre-existing Type 2 diabetes mellitus at new obstetric visits for individuals at high risk of developing GDM. For those who do not screen positive, but still may be at risk for GDM, standard practice is for basic diet, exercise, and weight gain counseling.
In this study, eligible participants will be randomized into one of two groups: usual care with standard diet and exercise counseling or a GDM prevention program that consists of a more intensive exercise and monitoring program.
All participants will be asked to wear an activity tracker and continuous glucose monitors (CGMs) at specified time points throughout their pregnancy. Blood will be drawn at specified time points to measure hemoglobin A1c, lipids, and HOMA-IR measures.
842 studies on the registry are indexed under Diabetes, Gestational; 198 are open to participants now.
Browse Diabetes, Gestational studies →Indiana University is the lead sponsor of 958 studies on the registry; 200 are open to participants now.
Of its 142 completed or terminated interventional studies of FDA-regulated products, 112 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Major fetal anomalies:
This arm consists of standard of care counseling for diet and exercise.
This arm consists of a more intensive exercise and monitoring program. .
Behavioral: GDM Prevention Program
Participants will receive hybrid and group monthly contacts with registered dieticians and lifestyle coaches. Participants will attend monthly in-person physical activity sessions.
Time spent in euglycemia
percentage of time in a day spent in euglycemia
Time frame: 7 days per month
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Indiana University