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

NCT05528380 | Completed DMC

• 1 other identifier: 1R34DA055317-01A1
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy; Cannabis

Outcome Measures

Primary Outcomes (11)

• Timeline Follow-back (TLFB)

  Interviewer-administered assessment of use of cannabis, alcohol, tobacco, and other drugs

  Baseline to 12-week endpoint

• Steps/day

  objectively-measured

  Baseline to 12-week endpoint

• Activity Minutes/Day

  objectively-measured

  Baseline to 12-week endpoint

• The Daily Sessions, Frequency & Quantity of Cannabis Use Inventory - Factor 1

  Self-reported cannabis use questionnaire -factor 1: daily sessions

  Baseline to 12-week endpoint

• The Daily Sessions, Frequency & Quantity of Cannabis Use Inventory - Factor 2

  Self-reported cannabis use questionnaire - factor 2: frequency

  Baseline to 12-week endpoint

• The Daily Sessions, Frequency & Quantity of Cannabis Use Inventory - Factor 3

  Self-reported cannabis use questionnaire - factor 3: age of onset

  Baseline to 12-week endpoint

• The Daily Sessions, Frequency & Quantity of Cannabis Use Inventory - Factor 4

  Self-reported cannabis use questionnaire - factor 4: Marijuana quantity

  Baseline to 12-week endpoint

• The Daily Sessions, Frequency & Quantity of Cannabis Use Inventory - Factor 5

  Self-reported cannabis use questionnaire - factor 5: Concentrate quantity

  Baseline to 12-week endpoint

• The Daily Sessions, Frequency & Quantity of Cannabis Use Inventory - Factor 6

  Self-reported cannabis use questionnaire - factor 6: Edibles quantity

  Baseline to 12-week endpoint

• Urine Toxicology Screen

  Objective screening for use of cannabis via measurement of THC in urine samples

  Baseline to 12-week endpoint

• International Physical Activity Questionnaire

  self-report measure of physical activity including minutes/week spent walking, engaging in moderate physical activity, and engaging in vigorous physical activity

  Baseline to 12-week endpoint

Secondary Outcomes (4)

• Brief COPE

  Baseline to 12-week endpoint

• Marijuana Self-Efficacy Questionnaire

  Baseline to 12-week endpoint

• Edinburgh Postnatal Depression Screen

  Baseline to 12-week endpoint

• Generalized Anxiety Disorder -7

  Baseline to 12-week endpoint

Study Arms (1)

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.

Behavioral: LPA + Fitbit Intervention

Interventions

LPA + Fitbit Intervention BEHAVIORAL

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.

Also known as: Women Out Walking

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged 18+
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Butler Hospital: lead

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

Marijuana Abuse

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2022
• First Posted: September 6, 2022
• Study Start: January 30, 2022
• Primary Completion: May 15, 2024
• Study Completion: October 15, 2024
• Last Updated: February 23, 2026

Record last verified: 2026-02

Locations

US (1)