Lifestyle Interventions to Improve Glycemic Parameters and Reduce Gestational Diabetes in High-risk Pregnant Individuals
August 24, 2026 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
Withdrawn
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
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 Locations
-
-
Indiana
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Indianapolis, Indiana, United States, 46202
- Sidney and Lois Eskenazi Hospital
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-
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.
|
|
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Experimental: GDM Prevention Program
This arm consists of a more intensive exercise and monitoring 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
Investigators
- Principal Investigator: David M Haas, MD, Indiana University
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)
August 26, 2026
Last Update Submitted That Met QC Criteria
August 24, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
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.