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

December 10, 2025 updated by: David Haas, Indiana University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: David M Haas, MD
  • Phone Number: 317-880-3960
  • Email: dahaas@iu.edu

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Sidney and Lois Eskenazi Hospital
        • Contact:
        • Principal Investigator:
          • David M Haas, MD, MS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 disease
  • Obstructive uropathy
  • Horseshoe kidney
  • Megacystis microcolon
  • Cloacal abnormality
  • Achondrogenesis
  • Thanatophoric dysplasia
  • Thoracic dysplasia
  • Osteogenesis imperfecta
  • Short rib polydacyly
  • Any skeletal defect with suspected small thorax
  • Hypophosphatemia
  • Any karyotypic abnormality
  • Any suspected genetic syndrome
  • Cleft lip/palate
  • Micrognathia
  • Hydrops
  • Fetal anemia (<35% on cordocentesis)
  • Neck mass
  • Gastroschsis
  • Omphalocele

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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. .
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time spent in euglycemia
Time Frame: 7 days per month
percentage of time in a day spent in euglycemia
7 days per month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Collaborators

University of Texas
Northeastern University

Investigators

  • Principal Investigator: David M Haas, MD, Indiana University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

August 1, 2030

Study Completion (Estimated)

December 1, 2031

Study Registration Dates

First Submitted

May 31, 2024

First Submitted That Met QC Criteria

May 31, 2024

First Posted (Actual)

June 6, 2024

Study Record Updates

Last Update Posted (Actual)

December 18, 2025

Last Update Submitted That Met QC Criteria

December 10, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PREVENT-GDM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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