Fitbit and coaching may help pregnant women cut cannabis use
NCT ID NCT05528380
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
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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
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16 people
The number who actually took part.
- Started
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Jan 2022
- Finished
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Oct 2024
- Lead sponsor
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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
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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
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Butler Hospital
Providence, Rhode Island, 02906, United States
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