PregnancyNCT05528380
Development of a Lifestyle Physical Activity Intervention to Reduce Risk for Perinatal Cannabis Use
A study testing LPA + Fitbit Intervention in people with Pregnancy and Cannabis, run by Butler Hospital at 1 site in United States.
Trial summary
This study will recruit 20 women who are high risk for prenatal cannabis use for a 12-week program of using the tracker and receiving a Lifestyle Physical Activity program. The primary outcomes will be self reported percent days of cannabis use and physical activity. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- What is being tested?
- LPA + Fitbit Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2022to 15 Oct 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
This study will recruit 20 women who are high risk for prenatal cannabis use for a 12-week program of using the tracker and receiving a Lifestyle Physical Activity program. The primary outcomes will be self reported percent days of cannabis use and physical activity. Secondary outcomes include self -reported measures of depression and anxiety symptoms, adaptive coping, and self-efficacy for cannabis abstinence.
Read the detailed description
This study will recruit 20 women in an open trial who are high risk for prenatal cannabis use for a 12-week program of using a Fitbit activity tracker and receiving a Lifestyle Physical Activity program. The primary outcomes will be self reported percent days of cannabis use and physical activity. Secondary outcomes include self -reported measures of depression and anxiety symptoms, adaptive coping, and self-efficacy for cannabis abstinence. The investigators will clinically monitor all participants in the study for safety and clinical deterioration, and measure a variety of symptom outcomes over the course of the intervention period during pregnancy, as well as at a postpartum follow-up.
- Being tested
- LPA + Fitbit Intervention
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LPA + Fitbit InterventionBehavioural
Also called Women Out Walking
Participants will receive a Fitbit to track activity levels and participate in a 6-session lifestyle physical activity intervention over the course of 12 weeks. The intervention consists of 20-25 minute phone or video-delivered session to: (a) review PA progress and re-evaluate current step-count goals, (b) problem-solve barriers to incorporating PA into their daily lives, (c) address difficulties utilizing the Fitbit, (d) encourage the use of bouts of PA as a coping strategy, and e) engage the participant in brief discussions focused on increasing and maintaining PA.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | In the Open Trial all participants received a Fitbit to track activity levels and participate in a 6-session lifestyle physical activity intervention over the course of 12 weeks. The intervention consists of 20-25 minute phone or video-delivered session to: (a) review PA progress and re-evaluate current step-count goals, (b) problem-solve barriers to incorporating PA into their daily lives, (c) address difficulties utilizing the Fitbit, (d) encourage the use of bouts of PA as a coping strategy, and e) engage the participant in brief discussions focused on increasing and maintaining PA. Receives: Behavioral: LPA + Fitbit Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Using Cannabis
Number of participants using cannabis at week 12, assessed via the Timeline Follow Back
Measured: from week 6 to the end of the intervention at week 12
Steps/Day
objectively-measured via wearable device
Measured: Baseline to 12-week endpoint
International Physical Activity Questionnaire (IPAQ) Walked 10+ Continuous Min/Day
Number who reported walking 4 or more days/week for 10 or more continuous minutes per day
Measured: Baseline to 12-week endpoint
Secondary outcomes (3)
Edinburgh Postnatal Depression Screen
Self-report measure of depression severity; scores range from 0-30, with higher scores indicating more severe depression
Measured: past week, assessed at week 12 (end of intervention)
Generalized Anxiety Disorder -7
Self-report measure of anxiety severity; scores range from 0-21, with higher scoring indicating more severe anxiety
Measured: past 2 weeks, assessed at week 12 (end of intervention)
Client Satisfaction Questionnaire (CSQ-8)
The Client Satisfaction Questionnaire is an 8 item survey of participant satisfaction. Scores range from 8-32; higher scores indicate higher satisfaction.
Measured: Week 12 End of Treatment (EOT)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2022
- Study start30 Jan 2022
- Primary completion15 May 2024
- Study completion15 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Butler Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05528380
- Sponsor's protocol ID
- 1R34DA055317-01A1
- Status last verified
- Feb 2026
- First submitted
- 19 Jul 2022
- Last updated
- 13 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Lifestyle Physical Activity Intervention to Reduce Risk for Perinatal Cannabis Use
- ClinicalTrials.gov ID
- NCT05528380
- Acronym / sponsor ID
- 1R34DA055317-01A1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Butler HospitalUniversity, hospital or other
- Study start
- 30 Jan 2022 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 15 Oct 2024 (actual)
- First posted
- 6 Sep 2022 (actual)
- Results
- Posted 13 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will recruit 20 women who are high risk for prenatal cannabis use for a 12-week program of using the tracker and receiving a Lifestyle Physical Activity program. The primary outcomes will be self reported percent days of cannabis use and physical activity. Secondary outcomes include self -reported measures of depression and anxiety symptoms, adaptive coping, and self-efficacy for cannabis abstinence.
Detailed description
This study will recruit 20 women in an open trial who are high risk for prenatal cannabis use for a 12-week program of using a Fitbit activity tracker and receiving a Lifestyle Physical Activity program. The primary outcomes will be self reported percent days of cannabis use and physical activity. Secondary outcomes include self -reported measures of depression and anxiety symptoms, adaptive coping, and self-efficacy for cannabis abstinence. The investigators will clinically monitor all participants in the study for safety and clinical deterioration, and measure a variety of symptom outcomes over the course of the intervention period during pregnancy, as well as at a postpartum follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: LPA + Fitbit InterventionIn the Open Trial all participants received a Fitbit to track activity levels and participate in a 6-session lifestyle physical activity intervention over the course of 12 weeks. The intervention consists of 20-25 minute phone or video-delivered session to: (a) review PA progress and re-evaluate current step-count goals, (b) problem-solve barriers to incorporating PA into their daily lives, (c) address difficulties utilizing the Fitbit, (d) encourage the use of bouts of PA as a coping strategy, and e) engage the participant in brief discussions focused on increasing and maintaining PA. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LPA + Fitbit InterventionAlso: Women Out WalkingParticipants will receive a Fitbit to track activity levels and participate in a 6-session lifestyle physical activity intervention over the course of 12 weeks. The intervention consists of 20-25 minute phone or video-delivered session to: (a) review PA progress and re-evaluate current step-count goals, (b) problem-solve barriers to incorporating PA into their daily lives, (c) address difficulties utilizing the Fitbit, (d) encourage the use of bouts of PA as a coping strategy, and e) engage the participant in brief discussions focused on increasing and maintaining PA. | Behavioural | Intervention |
Primary outcome
Number of Participants Using Cannabis
Time frame: from week 6 to the end of the intervention at week 12
Number of participants using cannabis at week 12, assessed via the Timeline Follow Back
Steps/Day
Time frame: Baseline to 12-week endpoint
objectively-measured via wearable device
International Physical Activity Questionnaire (IPAQ) Walked 10+ Continuous Min/Day
Time frame: Baseline to 12-week endpoint
Number who reported walking 4 or more days/week for 10 or more continuous minutes per day
3 secondary outcomes
Edinburgh Postnatal Depression Screen
Time frame: past week, assessed at week 12 (end of intervention)
Generalized Anxiety Disorder -7
Time frame: past 2 weeks, assessed at week 12 (end of intervention)
Client Satisfaction Questionnaire (CSQ-8)
Time frame: Week 12 End of Treatment (EOT)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LPA + Fitbit Intervention in people with Pregnancy and Cannabis, run by Butler Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Using Cannabis (time frame: from week 6 to the end of the intervention at week 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.