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Fitbit and coaching may help pregnant women cut cannabis use

NCT ID NCT05528380

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Aug 14, 2026 · Updated 3 times

Summary

This study tested whether a lifestyle physical activity program, using a Fitbit tracker and coaching calls, could help pregnant women at risk for cannabis use reduce their use. Sixteen women who used cannabis at least weekly before pregnancy and had mild depression or anxiety took part in a 12-week program. Researchers measured cannabis use, physical activity, mood, and coping skills to see if the approach was feasible and promising.

What this could mean

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

Active substance
lifestyle physical activity program with Fitbit
What this could lead to
If it works, this could point toward a simple, non-drug way to help pregnant women cut back on cannabis and improve their mental health.
What could go wrong
This was a very small, early study with only 16 participants and no comparison group. The results may not apply to all pregnant women, and it relied on self-reported cannabis use.

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

16 people

The number who actually took part.

Started

Jan 2022

Finished

Oct 2024

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: * Women aged 18+ * 12-25 weeks gestation with a healthy singleton pregnancy * Medically cleared for moderate physical activity * Self-report of cannabis use at least once/week in the 3 months prior to the pregnancy desire to not engage in prenatal cannabis use * Elevated depression (EPDS\>=7) or anxiety (GAD7\>=5) * English-speaking * Owns a smartphone to enable use of the Fitbit app * Current physical activity does not meet health recommendations (150 min/week mod intensity activity) * Expresses interest in reducing or discontinuing cannabis use Exclusion Criteria: * Current DSM-5 diagnosis of moderate/severe substance use disorder other than CUD or nicotine use disorder * Use of illicit substances in the last 3 months (other than cannabis) * Acute psychotic symptoms * Current or recent suicidality or homicidally * Current anorexia or bulimia * Cognitive impairment * Physical or medical problems that would not allow safe participation in moderate intensity PA (i.e., not medical cleared by Ob/Gyn) * Has a plan to relocate away from the area during study period * Recently started new mental health or substance use treatment within past 4 weeks.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Butler Hospital

    Providence, Rhode Island, 02906, United States

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