Gestational Diabetes, Pregnancy Complications
Conditions
Keywords
gestational diabetes, prevention, pregnancy, continuous glucose monitor
Brief summary
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.
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.
Interventions
BEHAVIORALGDM 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.
Sponsors
Indiana University
Northeastern University
University of Texas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
14 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time spent in euglycemia | 7 days per month | percentage of time in a day spent in euglycemia |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDavid M Haas, MD
Indiana University
Outcome results
None listed