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Free meals and coaching aim to cut pregnancy risks

NCT ID NCT06320054

Prevention Sponsor: Medical College of Wisconsin 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 21, 2026 · Updated 2 times

Summary

This study tests whether providing fresh meals, health coaching, and education to high-risk pregnant women can reduce the chance of developing gestational diabetes, high blood pressure, or preeclampsia. 69 women in Milwaukee are randomly assigned to either receive the program or standard care. Researchers will compare outcomes like weight gain, blood pressure, and birth timing between the two groups.

What this could mean

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

Active substance
Medically tailored meal program with health coaching
What this could lead to
If it works, this could point toward a simple, non-drug way to lower the chance of serious pregnancy complications like gestational diabetes and preeclampsia.
What could go wrong
This is a small early study with only 69 participants, so results may not apply to everyone. It also relies on participants sticking with the program, which can be challenging.

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

69 people

The number who actually took part.

Started

Jun 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

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

18 to 50 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: 1. Age at enrollment ≥ 18 years of age 2. Receiving prenatal care at Froedtert 3. ≤ 16 weeks and 6 days of gestation 4. At risk of preeclampsia, defined as being eligible for low dose aspirin treatment AND/OR at risk for gestational diabetes defined as having a history of gestational diabetes, OR previously given birth to an infant weighing ≥ 4000 g, OR has a diagnosis of PCOS 5. Pre-pregnancy Body Mass Index ≥ 25 kg/m\^2 6. Resides in Milwaukee County at time of consent 7. Low socio-economic status (\<200% of FPL defined as receiving Medicaid) 8. Able to read and communicate in English 9. Has access to a smart device/computer with reliable internet connection 10. Has access to a working refrigerator 11. Viable singleton pregnancy Exclusion criteria: 1. Diagnosed with Type I or Type II Diabetes or Hemoglobin A1C ≥ 6.5% 2. Diagnosed with End Stage Renal Disease 3. Use of weight-increasing psychotropic agents 4. Active inflammatory bowel disease, or history of bowel resection or malabsorptive syndrome, or history of bariatric surgery 5. Significant food allergies, preferences or dietary requirements that would interfere with diet adherence 6. Multifetal gestation 7. Active substance use that would preclude program adherence 8. Chronic use of oral corticosteroids 9. Unable to provide informed consent

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Conditions

The condition(s) this trial relates to.

gestational diabetes prevention target hypertension, pregnancy-induced prevention target preeclampsia prevention target

As listed by the trial registrant

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

Gestational diabetes Gestational hypertension High-risk pregnancy Preeclampsia

Contacts and locations

Locations

  • Froedert & The Medical College of Wiscosin

    Milwaukee, Wisconsin, 53226, United States

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