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Pregnancy stress? a Step-Count program might help

NCT ID NCT06430853

Symptom relief Sponsor: Stanford University 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Updated 1 time

Summary

This study tests whether a physical activity program can help pregnant people with symptoms of depression or anxiety feel better. 88 participants will be given a step goal and wear an activity tracker. The program includes weekly reminders and motivational coaching every two weeks. Researchers will measure changes in mood and stress markers over time.

What this could mean

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

Active substance
physical activity program (step count goal with motivational coaching)
What this could lead to
If it works, this could offer a simple, drug-free way to ease depression and anxiety during pregnancy.
What could go wrong
This is a small, early-stage trial with only 88 participants. The intervention is behavioral, so results may vary widely and may not apply to all pregnant people.

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 88 people

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

Started

Jan 2025

Expected to finish

Jun 2027

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: * Able to read and write in English or Spanish * Presenting for a prenatal visit with a viable singleton gestation (no known lethal fetal anomaly or plan for pregnancy termination) between 18 and 20 weeks 0 days * Any history of depression or anxiety, defined as: 1) documented depression or anxiety in the medical record within the preceding 2 years; 2) baseline EPDS score \>=10 at intake prenatal visit; 3) baseline EPDS anxiety subscale 3A score \>=5 Exclusion Criteria: * Known allergy to steel or rubber * Implantable medical device * Contraindication to physical activity such as a pre-existing cardiovascular condition or arrhythmia * Plan to relocate and/or deliver at another institution * Concurrent severe mental illness (diagnosis of bipolar disorder or schizophrenia) * Known lethal fetal anomaly or nonviable pregnancy * Baseline \>30 min per week of vigorous physical activity (from Pregnancy Physical Activity Questionnaire, PPAQ)

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Conditions

The condition(s) this trial relates to.

anxiety anxiety disorder Chronobiology Disorders Depression depressive disorder Motor Activity pregnancy disorder Psychological Well-Being

As listed by the trial registrant

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

Biological clock disturbance Depression, anxiety Mental health issue Pregnancy complications Pregnancy, high risk

How to take part

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

  1. The places running it

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

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Stanford University

    Stanford, California, 94305, United States

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