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NCT Number: NCT06445270

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

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.

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Key information

Conditions

Gestational Diabetes Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

14 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sidney and Lois Eskenazi Hospital

Indianapolis, Indiana, 46202, United States

Location contact

David M Haas, MD, MS

PRINCIPAL_INVESTIGATOR

Kathleen Flannery

CONTACT

[email protected]

317-880-3961

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GDM Prevention Program

Behavioral

Participants will receive hybrid and group monthly contacts with registered dieticians and lifestyle coaches. Participants will attend monthly in-person physical activity sessions.

Primary outcomes

  1. Time spent in euglycemia

    Time frame: 7 days per month

    percentage of time in a day spent in euglycemia

Study contacts

Contact information is provided by the study sponsor or research team.

David M Haas, MD

CONTACT

[email protected]

317-880-3960

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Northeastern University
  • University of Texas

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2030
Study completion
2031
First posted
Jun 6, 2024
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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