Lifestyle Interventions to Improve Glycemic Parameters and Reduce Gestational Diabetes in High-risk Pregnant Individuals
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: GDM Prevention Program.
- Who it may be relevant to
- Registry conditions: Gestational Diabetes, Pregnancy Complications. Basic parameters: from 14 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evidence-informed Lifestyle Interventions to Improve Glycemic Parameters and Reduce Gestational Diabetes in High-risk Pregnant Individuals
Overview
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
- 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.
Primary outcome measures
- Time spent in euglycemia [Time frame: 7 days per month]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Sidney and Lois Eskenazi Hospital — Indianapolis
Identifiers
NCT: NCT06445270 · PREVENT-GDM