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

Gestational Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06445270
• Other study ID #: PREVENT-GDM
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2025
• Est. completion date: December 2030

Study information

• Verified date: May 2024
• Source: Indiana University
• Contact: David M Haas, MD
• Phone: 317-880-3960
• Email: dahaas[@]iu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2030
• Est. primary completion date: April 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes
• Pregnancy Complications

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Sidney and Lois Eskenazi Hospital	Indianapolis	Indiana

Sponsors (3)

Lead Sponsor	Collaborator
Indiana University	Northeastern University, University of Texas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time spent in euglycemia		7 days per month