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

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Indiana University
Study ID
NCT06445270
Status
Not Yet Recruiting

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Conditions

  • Gestational Diabetes
  • Pregnancy Complications

Eligibility Criteria

Sex
FEMALE
Age
14 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • GDM Prevention Program — BEHAVIORAL
    Participants will receive hybrid and group monthly contacts with registered dieticians and lifestyle coaches. Participants will attend monthly in-person physical activity sessions.

Study Details

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.

Key Dates

Start date
Aug 31, 2026
Status verified
Dec 2025
Primary completion
Aug 31, 2030
Completion
Dec 31, 2031

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • No Intervention: Control
    This arm consists of standard of care counseling for diet and exercise.
  • Experimental: GDM Prevention Program
    This arm consists of a more intensive exercise and monitoring program. .

Primary Outcome Measure

Time spent in euglycemia [ Time Frame: 7 days per month ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Sidney and Lois Eskenazi HospitalIndianapolisIndiana46202
Kathleen Flannery
[email protected]
317-880-3961
David M Haas, MD, MS (PRINCIPAL_INVESTIGATOR)

Find similar trials in Indianapolis, IN

By research site
Sidney and Lois Eskenazi Hospital· Indianapolis, IN

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