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Can a mediterranean diet help overweight Moms-to-Be eat healthier?

NCT ID NCT05868954

Knowledge-focused Sponsor: Wake Forest University Health Sciences 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 pilot study compared two healthy eating plans for overweight or obese pregnant women in a low-resource clinic. Forty-one women were randomly assigned to either standard healthy diet advice or a Mediterranean diet program that included free meals, olive oil, and nuts. Researchers measured how well women stuck to their assigned diet and tracked weight gain during pregnancy. The goal was to see if the Mediterranean approach is practical and effective in this setting.

What this could mean

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

Active substance
Mediterranean diet program (behavioral intervention with free meals, olive oil, and nuts)
What this could lead to
If successful, this could show that a Mediterranean diet program is feasible and helps overweight pregnant women control weight gain and improve diet quality.
What could go wrong
This is a small pilot study with only 41 participants, so results may not apply widely. The diet program requires significant support (free food, counseling) that may not be available in all low-resource settings.

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

41 people

The number who actually took part.

Started

Aug 2023

Finished

Jul 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

18 years and older

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: * Viable singleton pregnancy in the first trimester (6 0/7- 16 6/7 weeks); includes twins reduced to singleton spontaneously or vanishing twin syndrome * BMI ≥ 25.0 kg/m2; calculated by dividing maternal weight in kilograms by height in meters squared using a calibrated scale and standard metric measure * Confirmed intrauterine pregnancy by ultrasound exam (6-16 weeks) * Age 18 years or older * Primary language of English or Spanish Exclusion Criteria: * BMI \< 25.0 kg/m2 * Known pre-pregnancy diabetes * Hemoglobin glycosylated (A1C) \> 5.7% at first prenatal visit * Pre-pregnancy hypertensive disease * Non-viable pregnancy * Known allergies to an essential component(s) of MedDiet * Inability to read or write in primary language * Mental incapacity to make medical decisions

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Conditions

The condition(s) this trial relates to.

Gestational Weight Gain Obesity Overweight

As listed by the trial registrant

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

Diet, healthy Gestational weight gain

Contacts and locations

Locations

  • Atrium Health Myers Park OB/GYN

    Charlotte, North Carolina, 28207, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.