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

NCT06445270 | Not Yet Recruiting

• 1 other identifier: PREVENT-GDM
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gestational Diabetes; Pregnancy Complications

Keywords

gestational diabetes; prevention; pregnancy; continuous glucose monitor

Outcome Measures

Primary Outcomes (1)

• Time spent in euglycemia

  percentage of time in a day spent in euglycemia

  7 days per month

Study Arms (2)

Control

NO INTERVENTION

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

GDM Prevention Program

EXPERIMENTAL

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

Behavioral: GDM Prevention Program

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.

GDM Prevention Program

Eligibility Criteria

• Age: 14 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Gestational age less or equal to 16 + 6 weeks confirmed via ACOG dating guidelines AND one of the following
• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead
• Northeastern University: collaborator
• University of Texas: collaborator

Study Sites (1)

Sidney and Lois Eskenazi Hospital

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Diabetes, Gestational; Pregnancy Complications

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• David M Haas, MD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David M Haas, MD

CONTACT

317-880-3960; dahaas@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Munsick Professor of Obstetrics and Gynecology

Study Record Dates

• First Submitted: May 31, 2024
• First Posted: June 6, 2024
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): December 1, 2031
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)