Lifestyle Interventions to Improve Glycemic Parameters and Reduce Gestational Diabetes in High-risk Pregnant Individuals
NCT ID: NCT06445270
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
100 participants
INTERVENTIONAL
2026-08-31
2031-12-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Control
This arm consists of standard of care counseling for diet and exercise.
No interventions assigned to this group
GDM Prevention Program
This arm consists of a more intensive exercise and monitoring program. .
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
14 Years
FEMALE
Yes
Sponsors
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Northeastern University
OTHER
University of Texas
OTHER
Indiana University
OTHER
Responsible Party
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David Haas
Munsick Professor of Obstetrics and Gynecology
Principal Investigators
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David M Haas, MD
Role: PRINCIPAL_INVESTIGATOR
Indiana University School of Medicine
Locations
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Sidney and Lois Eskenazi Hospital
Indianapolis, Indiana, United States
Countries
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Central Contacts
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Facility Contacts
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Kathleen Flannery
Role: primary
Other Identifiers
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PREVENT-GDM
Identifier Type: -
Identifier Source: org_study_id