Image

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

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

Recruiting
18 years and older
Female
Phase N/A

Powered by AI

Overview

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.

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.

Eligibility

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 details
    Pregnancy
    Cannabis

NCT05528380

Butler Hospital

16 October 2025

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.