Frontlight ResearchEarly access
WithdrawnNo phase
Lifestyle Interventions to Improve Glycemic Parameters and Reduce Gestational Diabetes in High-risk Pregnant Individuals
Key facts
- Who runs it
- Indiana University
- Where
- Indianapolis, United StatesSee the site
- Trial code
- Status
- Withdrawn
- Started
- Aug 2026
- Expected to end
- Dec 2031
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- GDM Prevention Program
- Record updated
- 26 August 2026
- Why it stopped
- No funding
Who can take part
- Age
- 14 years and older
- Sex
- Women only
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 59 criteriaShow less
Who can take part
- 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%
Who cannot take part
- Pre-pregnancy chronic (>2 weeks) usage of systemic steroids (inhaled and short term usage acceptable)
- Currently taking or took 3 months prior to conception Metformin
- Major fetal anomalies listed below that are known prior to enrollment; Major fetal anomalies:
- Current diagnosis of Type 1 or 2 diabetes mellitus including a diagnosis during this pregnancy
- Hypoplastic left heart syndrome
- Fetal arrhythmias
- Cystic renal disease
- Any suspected genetic syndrome
- Multiple gestations
- Planned pregnancy termination
- Unable to provide informed consent in English or Spanish
- 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
- Aortic coarctation
- 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
- 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
- Cleft lip/palate
- Micrognathia
- Hydrops
- Fetal anemia (<35% on cordocentesis)
- Neck mass
- Gastroschsis
- Omphalocele
Where in United States
- Sidney and Lois Eskenazi HospitalIndianapolis, United States
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- ControlNo study treatment, for comparison
This arm consists of standard of care counseling for diet and exercise.
- GDM Prevention ProgramTreatment being tested
This arm consists of a more intensive exercise and monitoring program. .
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Evidence-informed Lifestyle Interventions to Improve Glycemic Parameters and Reduce Gestational Diabetes in High-risk Pregnant Individuals
- Record updated
- 26 August 2026