Lifestyle Interventions to Improve Glycemic Parameters an... | NCT06445270

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

NCT06445270

Sponsor

Indiana University

Status

Not yet recruiting

Last Update Posted

Dec 18, 2025Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Gestational Diabetes
Pregnancy Complications

Interventions

GDM Prevention Program

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2026Estimated

Primary Completion Date

Aug 2030Estimated

Completion Date

Dec 2031Estimated

First Submitted Date

May 31, 2024

First Submission Date that Met QC Criteria

May 31, 2024

First Posted Date

Jun 6, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 10, 2025

Last Update Posted Date

Dec 18, 2025Actual

Name	Class
Northeastern University	OTHER
University of Texas	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	No Intervention	This arm consists of standard of care counseling for diet and exercise.
GDM Prevention Program	Experimental	This arm consists of a more intensive exercise and monitoring program. .	Behavioral: GDM Prevention Program

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Measure	Description	Time Frame
Time spent in euglycemia	percentage of time in a day spent in euglycemia	7 days per month

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D016640	Diabetes, Gestational
D011248	Pregnancy Complications

ID	Term
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders