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Meal delivery and coaching aim to stop diabetes in new moms

NCT ID NCT06988306

Prevention Sponsor: California Polytechnic State University-San Luis Obispo Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests whether extra lifestyle coaching plus medically tailored meals can help prevent type 2 diabetes in mothers who had gestational diabetes. Nearly 1,000 pregnant or recently postpartum women from home visiting programs will be randomly assigned to receive either enhanced lifestyle support alone or the same support plus healthy meals. The main goal is to see if these approaches reduce diabetes and pre-diabetes rates one year after giving birth.

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 978 people

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

Started

Jan 2026

Expected to finish

Apr 2030

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 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: * Currently in home visiting * Pregnant or \< 3 months (13 weeks) postpartum * Gestational Diabetes Mellitus diagnosis in most recent pregnancy (based on self-report) * Aged 18 years or older * English- or Spanish-speaking. * Not currently being given medically tailored meals * Willing to receive randomization to either group Exclusion Criteria: • Pre-existing diabetes (based on self-report)

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Conditions

The condition(s) this trial relates to.

diabetes mellitus gestational diabetes prediabetes syndrome prevention target type 2 diabetes mellitus prevention target

As listed by the trial registrant

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

Diabetes mellitus Gestational diabetes mellitus (GDM)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. 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

  • California Polytechnic State University

    RECRUITING

    San Luis Obispo, California, 93401, United States

  • Miriam Hospital

    NOT_YET_RECRUITING

    Providence, Rhode Island, 02906, United States

  • Northwestern University

    NOT_YET_RECRUITING

    Chicago, Illinois, 60611, United States

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