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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
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.
Butler Hospital
Providence, Rhode Island, United States
Number of Participants Using Cannabis
Number of participants using cannabis at week 12, assessed via the Timeline Follow Back
Time frame: from week 6 to the end of the intervention at week 12
Steps/Day
objectively-measured via wearable device
Time frame: Baseline to 12-week endpoint
International Physical Activity Questionnaire (IPAQ) Walked 10+ Continuous Min/Day
Number who reported walking 4 or more days/week for 10 or more continuous minutes per day
Time frame: Baseline to 12-week endpoint
Edinburgh Postnatal Depression Screen
Self-report measure of depression severity; scores range from 0-30, with higher scores indicating more severe depression
Time frame: past week, assessed at week 12 (end of intervention)
Generalized Anxiety Disorder -7
Self-report measure of anxiety severity; scores range from 0-21, with higher scoring indicating more severe anxiety
Time frame: past 2 weeks, assessed at week 12 (end of intervention)
Client Satisfaction Questionnaire (CSQ-8)
The Client Satisfaction Questionnaire is an 8 item survey of participant satisfaction. Scores range from 8-32; higher scores indicate higher satisfaction.
Time frame: Week 12 End of Treatment (EOT)
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