Not Yet RecruitingNot Applicable

Lifestyle Interventions to Improve Glycemic Parameters and Reduce Gestational Diabetes in High-risk Pregnant Individuals

United States100 participantsStarted 2026-08

Plain-language summary

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.

Who can participate

Age range

14 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Gestational age less or equal to 16 + 6 weeks confirmed via ACOG dating guidelines AND one of the following * 35 years of age or older * Family history of first degree relative with diabetes mellitus * Body Mass Index (BMI) greater than or equal to 30 * Hemoglobin A1c value between 5.9% to 6.4% Exclusion Criteria: * Multiple gestations * Current diagnosis of Type 1 or 2 diabetes mellitus including a diagnosis during this pregnancy * Pre-pregnancy chronic (\>2 weeks) usage of systemic steroids (inhaled and short term usage acceptable) * Planned pregnancy termination * Currently taking or took 3 months prior to conception Metformin * Unable to provide informed consent in English or Spanish * Major fetal anomalies listed below that are known prior to enrollment. Major fetal anomalies: * Congenital diaphragmatic hernia * Congenital cystic adenomatoid malformation * Pleural effustions * Chylothorax * Bronchogenic cyst * Bronchopulmonary sequestration * Anomalous pulmonary venous return * Tricuspid atresia * Mitral atresia * Double right ventricle * Ebstein's malformation * Pulmonary atresia * Hypoplastic left heart syndrome * Aortic coarctation * Fetal arrhythmias * Transposition of the great vessels * Tetrology of Fallot * Double outlet right ventricle * Aortic stenosis * Holoprosencephaly * Anencephaly * Dandy-Walker malformation or variant * Septo-optic dysplasia * Neural tube defect * Vein of Galen aneurysm * Bilateral renal agenesis * Cystic renal d…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Time spent in euglycemia

Timeframe: 7 days per month

Trial details

NCT IDNCT06445270

SponsorIndiana University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-08

Contact for this trial

David M Haas, MD

317-880-3960 dahaas@iu.edu

View on ClinicalTrials.gov More Gestational Diabetes trials