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

Not Applicable

Recruiting

• Conditions: Pregnancy; Cannabis

• Registration Number: NCT05528380
• Lead Sponsor: Butler Hospital

Brief 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. 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 Timeline

• Study Start: 2022-01-30
• Study First Submitted: 2022-07-19
• Study First Submitted QC: 2022-08-31
• Study First Posted: 2022-09-06
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-16
• Last Update Posted: 2025-07-17
• Primary Completion: 2026-02
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The Daily Sessions, Frequency & Quantity of Cannabis Use Inventory - Factor 3	Baseline to 12-week endpoint	Self-reported cannabis use questionnaire - factor 3: age of onset
Timeline Follow-back (TLFB)	Baseline to 12-week endpoint	Interviewer-administered assessment of use of cannabis, alcohol, tobacco, and other drugs
Steps/day	Baseline to 12-week endpoint	objectively-measured
The Daily Sessions, Frequency & Quantity of Cannabis Use Inventory - Factor 2	Baseline to 12-week endpoint	Self-reported cannabis use questionnaire - factor 2: frequency
The Daily Sessions, Frequency & Quantity of Cannabis Use Inventory - Factor 5	Baseline to 12-week endpoint	Self-reported cannabis use questionnaire - factor 5: Concentrate quantity
The Daily Sessions, Frequency & Quantity of Cannabis Use Inventory - Factor 6	Baseline to 12-week endpoint	Self-reported cannabis use questionnaire - factor 6: Edibles quantity
Urine Toxicology Screen	Baseline to 12-week endpoint	Objective screening for use of cannabis via measurement of THC in urine samples
The Daily Sessions, Frequency & Quantity of Cannabis Use Inventory - Factor 1	Baseline to 12-week endpoint	Self-reported cannabis use questionnaire -factor 1: daily sessions
International Physical Activity Questionnaire	Baseline to 12-week endpoint	self-report measure of physical activity including minutes/week spent walking, engaging in moderate physical activity, and engaging in vigorous physical activity
The Daily Sessions, Frequency & Quantity of Cannabis Use Inventory - Factor 4	Baseline to 12-week endpoint	Self-reported cannabis use questionnaire - factor 4: Marijuana quantity
Activity Minutes/Day	Baseline to 12-week endpoint	objectively-measured

Secondary Outcome Measures

Name	Time	Method
Generalized Anxiety Disorder -7	Baseline to 12-week endpoint	Self-report measure of anxiety severity; scores range from 0-21, with higher scoring indicating more anxiety
Brief COPE	Baseline to 12-week endpoint	Self-report measure of of use of coping strategies; includes 14 2-item scales, each ranging form 2-8. Higher scores indicate increased utilization of a coping strategy.
Marijuana Self-Efficacy Questionnaire	Baseline to 12-week endpoint	Self-report measure of efficacy for cannabis abstinence; Scores range from 0-100, with higher scores indicating greater use of strategies to reduce marijuana consumption.
Edinburgh Postnatal Depression Screen	Baseline to 12-week endpoint	Self-report measure of depression severity; scores range from 0-30, with higher scores indicating higher depression

Trial Locations

Locations (1)

Butler Hospital; 🇺🇸 Providence, Rhode Island, United States