Lifestyle Interventions for Gestational Diabetes Prevention

This study is testing whether a more intensive program of diet and activity counseling, called the GDM Prevention Program, can better control blood sugar and lower the risk of developing gestational diabetes (diabetes during pregnancy) compared to standard care. You might be able to join if you are pregnant, up to 16 weeks and 6 days along, and have certain risk factors like being 35 or older, having a family history of diabetes, a BMI of 30 or higher, or an A1c (a measure of average blood sugar) between 5.9% and 6.4%. The study will look at how much time participants spend with healthy blood sugar levels each month to see if the GDM Prevention Program is successful. This study is currently unclear about its recruitment status and plans to enroll 100 participants.

Study design
This is an interventional study where 100 participants will be randomly assigned to either receive standard diet and exercise counseling or the GDM Prevention Program.
What's involved
Participants will have monthly contacts with dieticians and lifestyle coaches, attend monthly in-person physical activity sessions, wear an activity tracker and continuous glucose monitors, and have blood drawn at specific times during pregnancy.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, time spent in euglycemia, is measured at 7 days per month, but the overall duration of follow-up is not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06445270

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

Withdrawn
NAAges 14+InterventionalPrevention
Indiana University
Updated 2026-08-26 on ClinicalTrials.gov
What's tested:GDM Prevention Program

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time spent in euglycemia
Measured over 7 days per month
Gestational Diabetes
Pregnancy Complications
1 sites across 1 states
Indiana1
  • David M Haas, MD · PRINCIPAL_INVESTIGATOR · Indiana University

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.
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
  • Time spent in euglycemia7 days per month

    percentage of time in a day spent in euglycemia