NCT06445270

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Indiana University · Academic / Other
• Sex: Female
• Age: 14 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Gestational Diabetes
• Pregnancy Complications

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-08-01
• Primary completion: 2030-08-01
• Completion: 2031-12-01
• First posted: 2024-06-06
• Last updated: 2025-12-18

Locations

1 site across 1 country: United States