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

No Placebo-Only Group

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.