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OpenTrials
Completed

NCT Number: NCT05528380

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Butler Hospital

Providence, Rhode Island, 02906, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Women Out Walking

Primary outcomes

  1. Timeline Follow-back (TLFB)

    Time frame: Baseline to 12-week endpoint

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

  2. Steps/day

    Time frame: Baseline to 12-week endpoint

    objectively-measured

  3. Activity Minutes/Day

    Time frame: Baseline to 12-week endpoint

    objectively-measured

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

    Time frame: Baseline to 12-week endpoint

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

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

    Time frame: Baseline to 12-week endpoint

    Self-reported cannabis use questionnaire - factor 2: frequency

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

    Time frame: Baseline to 12-week endpoint

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

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

    Time frame: Baseline to 12-week endpoint

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

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

    Time frame: Baseline to 12-week endpoint

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

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

    Time frame: Baseline to 12-week endpoint

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

  10. Urine Toxicology Screen

    Time frame: Baseline to 12-week endpoint

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

  11. International Physical Activity Questionnaire

    Time frame: 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

Secondary outcomes

  1. Brief COPE

    Time frame: 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.

  2. Marijuana Self-Efficacy Questionnaire

    Time frame: 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.

  3. Edinburgh Postnatal Depression Screen

    Time frame: Baseline to 12-week endpoint

    Self-report measure of depression severity; scores range from 0-30, with higher scores indicating higher depression

  4. Generalized Anxiety Disorder -7

    Time frame: Baseline to 12-week endpoint

    Self-report measure of anxiety severity; scores range from 0-21, with higher scoring indicating more anxiety

Sponsors and collaborators

Lead sponsor

Butler Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 6, 2022
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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