Development of a Lifestyle Physical Activity Intervention to Reduce Risk for Perinatal Cannabis Use

July 23, 2026 updated by: Butler Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Butler Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
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.
Behavioral: LPA + Fitbit Intervention
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.
Other Names:
  • Women Out Walking

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from week 6 to the end of the intervention at week 12
Steps/Day
Time Frame: Baseline to 12-week endpoint
objectively-measured via wearable device
Baseline to 12-week endpoint
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
Baseline to 12-week endpoint

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Edinburgh Postnatal Depression Screen
Time Frame: past week, assessed at week 12 (end of intervention)
Self-report measure of depression severity; scores range from 0-30, with higher scores indicating more severe depression
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)
Self-report measure of anxiety severity; scores range from 0-21, with higher scoring indicating more severe anxiety
past 2 weeks, assessed at week 12 (end of intervention)
Client Satisfaction Questionnaire (CSQ-8)
Time Frame: Week 12 End of Treatment (EOT)
The Client Satisfaction Questionnaire is an 8 item survey of participant satisfaction. Scores range from 8-32; higher scores indicate higher satisfaction.
Week 12 End of Treatment (EOT)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Butler Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2022

Primary Completion (Actual)

May 15, 2024

Study Completion (Actual)

October 15, 2024

Study Registration Dates

First Submitted

July 19, 2022

First Submitted That Met QC Criteria

August 31, 2022

First Posted (Actual)

September 6, 2022

Study Record Updates

Last Update Posted (Actual)

August 13, 2026

Last Update Submitted That Met QC Criteria

July 23, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R34DA055317-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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