Gestational DiabetesNCT06445270
Lifestyle Interventions to Improve Glycemic Parameters and Reduce Gestational Diabetes in High-risk Pregnant Individuals
A study testing GDM Prevention Program in people with Gestational Diabetes and Pregnancy Complications, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes, Pregnancy Complications
- What is being tested?
- GDM Prevention Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2026to Dec 2031
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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 join
- 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
Show all 55Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney and Lois Eskenazi Hospital
Indianapolis, Indiana, 46202
About this study
Official title: Evidence-informed 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.
Read the 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.
- Conditions
- Gestational Diabetes, Pregnancy Complications
- Being tested
- GDM Prevention Program
- Keywords
- gestational diabetes, prevention, pregnancy, continuous glucose monitor
- Medical subject headings
- Diabetes, Gestational, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GDM Prevention ProgramBehavioural
Participants will receive hybrid and group monthly contacts with registered dieticians and lifestyle coaches. Participants will attend monthly in-person physical activity sessions.
| Study group | Role | What they receive |
|---|---|---|
| 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. . Receives: Behavioral: GDM Prevention Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time spent in euglycemia
percentage of time in a day spent in euglycemia
Measured: 7 days per month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study startAug 2026 (estimated)
- Primary completionAug 2030 (estimated)
- Study completionDec 2031 (estimated)
Why it stopped: No funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Northeastern University, University of Texas
- Responsible party
- Principal investigator, David Haas, Indiana University
- Investigators
- David M Haas, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06445270
- Sponsor's protocol ID
- PREVENT-GDM
- Status last verified
- Aug 2026
- First submitted
- 31 May 2024
- Last updated
- 26 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evidence-informed Lifestyle Interventions to Improve Glycemic Parameters and Reduce Gestational Diabetes in High-risk Pregnant Individuals
- ClinicalTrials.gov ID
- NCT06445270
- Acronym / sponsor ID
- PREVENT-GDM
- Conditions
- Gestational Diabetes, Pregnancy Complications
- Keywords
- gestational diabetes, prevention, pregnancy, continuous glucose monitor
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Northeastern University, University of Texas
- Study start
- Aug 2026 (estimated)
- Primary completion
- Aug 2030 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 6 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –This arm consists of standard of care counseling for diet and exercise. |
| GDM Prevention Program | Experimental | Behavioral: GDM Prevention ProgramThis arm consists of a more intensive exercise and monitoring program. . |
Who may qualify
- Ages
- 14 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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%
Key exclusion criteria (55 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GDM Prevention ProgramParticipants will receive hybrid and group monthly contacts with registered dieticians and lifestyle coaches. Participants will attend monthly in-person physical activity sessions. | Behavioural | GDM Prevention Program |
Primary outcome
Time spent in euglycemia
Time frame: 7 days per month
percentage of time in a day spent in euglycemia
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David M Haas, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GDM Prevention Program in people with Gestational Diabetes and Pregnancy Complications, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 55 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time spent in euglycemia (time frame: 7 days per month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.