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Group prenatal care may cut diabetes risk for obese moms-to-be

NCT ID NCT04090307

Prevention Sponsor: University of North Carolina, Chapel Hill Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a group prenatal care program called TLC for obese women at high risk for gestational diabetes. Over 300 women joined small groups led by a healthcare provider and learned about nutrition, exercise, and healthy habits. The goal was to see if this approach could lower the chance of developing diabetes during pregnancy and improve baby health outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
group prenatal care with lifestyle education
What this could lead to
If successful, this approach could help prevent gestational diabetes and improve birth outcomes in high-risk women.
What could go wrong
The study is completed but results are not yet widely confirmed. Lifestyle interventions can be hard to sustain, and individual results may vary.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

305 people

The number who actually took part.

Started

Nov 2019

Finished

Oct 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

13 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * English speaking * ≤16 weeks gestation * Two or more of the following GDM risk factors: * BMI ≥ 25 * Physical inactivity * First degree relative with diabetes * High risk race or ethnicity (African American, Latino, Native American, Asian American, Pacific Islander) * Prior infant weighing ≥ 4,000 g * Prior GDM * Hypertension (140/90 mm Hg or receiving treatment) * High-density lipoprotein cholesterol level \<35 mg/dL or triglycerides \> 250 mg/dL * Polycystic ovarian syndrome * A1c ≥ 5.7% * Impaired glucose tolerance * Impaired fasting glucose on previous testing * History of cardiovascular disease * Ability to attend group prenatal visits at specified days and times * Willingness to be randomized * Ability to give informed consent Exclusion Criteria: * Type 2 diabetes (eligible for Diabetes Group Care) * Positive glucose challenge test during early pregnancy * Multiple gestation (require extra care) * Major fetal anomaly (require extra care) * Serious medical co-morbidity necessitating more care than can be safely provided in group setting, as deemed by medical provider (require extra care) * Serious psychiatric illness, including schizophrenia, necessitating more care than can be safely provided in group setting, as deemed by medical provider (require extra care)

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Conditions

The condition(s) this trial relates to.

diabetes mellitus gestational diabetes obesity disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gestational diabetes Pregnancy

Contacts and locations

Locations

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599, United States

  • Washington University in St. Louis

    St Louis, Missouri, 63110, United States

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