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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age14+
SponsorIndiana University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: ControlNo intervention 0 interventions
Group B: GDM Prevention ProgramExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Time spent in euglycemia

percentage of time in a day spent in euglycemia

Time frame
7 days per month

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Indiana University

Lead sponsor

Northeastern University

Collaborator

University of Texas

Collaborator

This trial is not recruiting at the moment. You can still explore other options: