Development of a Lifestyle Physical Activity Intervention to Reduce Risk for Perinatal Cannabis Use
- Conditions
- PregnancyCannabis
- Interventions
- Behavioral: LPA + Fitbit Intervention
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 50
- 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
- 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
- Arm && Interventions
Group Intervention Description Open Trial Intervention 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.
- Primary Outcome Measures
Name Time Method Activity Minutes/Day Baseline to 12-week endpoint objectively-measured
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
- 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