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Fresh produce prescription aims to cut gestational diabetes in High-Risk moms

NCT ID NCT07165990

Prevention Sponsor: The University of Texas Health Science Center, Houston 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tests whether giving high-risk pregnant women free deliveries of fresh produce, lean protein, and whole grains—plus nutrition classes—can prevent gestational diabetes. Researchers will enroll 400 women receiving care at Harris Health clinics who are early in pregnancy and have risk factors like obesity. The program runs from enrollment through 12 weeks after birth.

What this could mean

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

Active substance
Food is Medicine (FIM) intervention: bi-weekly home delivery of fresh produce, lean protein, and whole grains plus nutrition education
What this could lead to
If it works, this could show that providing healthy food and education to at-risk pregnant women can prevent gestational diabetes and related complications.
What could go wrong
This is a single-site study that hasn't started yet. Results may not apply to other populations, and the intervention may not be enough to change diabetes rates.

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

About 400 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2025

An estimate. Start dates often move.

Expected to finish

Oct 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 44 years

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: * pregnant women receiving care at Harris Health clinics * Medicaid eligible or receiving Medicaid * \<=14 weeks gestation at the time of the first prenatal visit and study enrollment * meet the ACOG criteria for early screening for GDM (have a BMI of 30 or greater and at least one additional ACOG-designated risk factor for GDM from the following: Age \> 35 years; Black, Hispanic, Native American, Asian American or Pacific Islander ethnicity; history of GDM in prior pregnancy; A1c level \> 5.7 \& \< 6.4; history of hypertension, pregnancy hypertension, heart disease, HIV, high triglycerides, polycystic ovarian syndrome; Immediate family member (parent or sibling) has had diabetes) * fall within the study delivery radius Exclusion Criteria: * report existing or pregestational T2DM * have hemoglobin A1c\>=7 * are prescribed insulin therapy or metformin upon first screening

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Conditions

The condition(s) this trial relates to.

gestational diabetes prevention target

As listed by the trial registrant

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

Gestational diabetes mellitus

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77006, United States

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