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Behavioral Intervention

Lifestyle Interventions for Gestational Diabetes

N/A
Waitlist Available
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Major fetal anomalies: Congenital diaphragmatic hernia, Congenital cystic adenomatoid malformation, Pleural effusions, 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, Tetralogy 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 polydactyly, 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, Gastroschisis, Omphalocele
Current diagnosis of Type 1 or 2 diabetes mellitus including a diagnosis during this pregnancy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

"This trial aims to see if a more intensive dietary and activity counseling program can help improve blood sugar control and lower the risk of developing gestational diabetes, compared to the current standard counseling."

Who is the study for?
This trial is for pregnant individuals at or before 16 weeks and 6 days, aged 35+, with a family history of diabetes, BMI of 30 or more, or Hemoglobin A1c between 5.9% to 6.4%. It excludes those with major fetal anomalies, multiple gestations, chronic steroid use (except inhaled/short-term), current/pre-pregnancy Type 1/2 diabetes diagnosis, recent Metformin use, or inability to consent in English/Spanish.
What is being tested?
The study tests if a high-intensity diet and activity counseling program can better control blood sugar and reduce the risk of developing gestational diabetes compared to standard counseling. Participants will receive different levels of dietary and activity guidance.
What are the potential side effects?
As this is a lifestyle intervention trial focusing on diet and exercise counseling rather than medication or invasive procedures, significant side effects are not anticipated.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My fetus has been diagnosed with a major anomaly.
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I have been diagnosed with diabetes, either Type 1 or 2, possibly during this pregnancy.
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I have been taking Metformin up to 3 months before getting pregnant.
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I can provide informed consent in English or Spanish.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: GDM Prevention ProgramExperimental Treatment1 Intervention
This arm consists of a more intensive exercise and monitoring program. .
Group II: ControlActive Control1 Intervention
This arm consists of standard of care counseling for diet and exercise.

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor
1,019 Previous Clinical Trials
1,114,115 Total Patients Enrolled
Northeastern UniversityOTHER
97 Previous Clinical Trials
70,772 Total Patients Enrolled
University of TexasOTHER
189 Previous Clinical Trials
143,039 Total Patients Enrolled
~67 spots leftby Apr 2029
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