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Tailored diet plans during pregnancy show promise in cutting preterm birth and diabetes risk

NCT ID NCT07559773

Disease control Sponsor: GrowBaby Life Project 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

The ROOT study is testing a personalized nutrition program for pregnant women. Participants receive standard prenatal care plus customized diet and lifestyle plans based on their genes and nutrient levels. The goal is to see if this approach can lower the chances of preterm birth, preeclampsia, gestational diabetes, and other complications. The study will follow 500 women and their children for up to 5 years.

What this could mean

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

Active substance
personalized nutrition and lifestyle plans with targeted micronutrient supplementation
What this could lead to
If successful, this approach could offer a simple, scalable way to lower the risk of serious pregnancy complications and improve long-term health for both mother and child.
What could go wrong
This is an early-stage study without a control group, so results may not prove cause and effect. Previous promising findings need confirmation in larger, more diverse populations.

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 500 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 2033

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: * Pregnant women receiving care at NH Triad OB/GYN * ≤20 weeks gestational age at enrollment * Age ≥ 18 years (\<18 years requires parental consent) * Ability to provide informed consent * Access to smart phone/internet for digital platform use Exclusion Criteria: * \> 20 weeks gestational age * High-risk pregnancies requiring specialized care beyond study scope * Inability to participate in digital health platform * Cognitive impairment preventing informed consent

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Conditions

The condition(s) this trial relates to.

atopic eczema autism childhood onset asthma Obesity obesity disorder otitis media otitis media, susceptibility to Pediatric Obesity preeclampsia Premature Birth fetal growth restriction prevention target gestational diabetes prevention target hypertension, pregnancy-induced prevention target

As listed by the trial registrant

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

Asthma childhood Atopic dermatitis Autism Gestational diabetes mellitus (GDM) Large for gestational age (LGA) Obesity Otitis media recurrent Preeclampsia Preterm birth Small for gestational age (SGA)

How to take part

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

  1. 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 ↗

  2. 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.

More trials for these conditions

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