Butler Hospital
Providence, Rhode Island, 02906, United States
NCT Number: NCT05528380
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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Notify Me18 year and older
Female
Interventional
Not applicable
Providence, Rhode Island, 02906, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: Baseline to 12-week endpoint
Interviewer-administered assessment of use of cannabis, alcohol, tobacco, and other drugs
Time frame: Baseline to 12-week endpoint
objectively-measured
Time frame: Baseline to 12-week endpoint
objectively-measured
Time frame: Baseline to 12-week endpoint
Self-reported cannabis use questionnaire -factor 1: daily sessions
Time frame: Baseline to 12-week endpoint
Self-reported cannabis use questionnaire - factor 2: frequency
Time frame: Baseline to 12-week endpoint
Self-reported cannabis use questionnaire - factor 3: age of onset
Time frame: Baseline to 12-week endpoint
Self-reported cannabis use questionnaire - factor 4: Marijuana quantity
Time frame: Baseline to 12-week endpoint
Self-reported cannabis use questionnaire - factor 5: Concentrate quantity
Time frame: Baseline to 12-week endpoint
Self-reported cannabis use questionnaire - factor 6: Edibles quantity
Time frame: Baseline to 12-week endpoint
Objective screening for use of cannabis via measurement of THC in urine samples
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
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.
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.
Time frame: Baseline to 12-week endpoint
Self-report measure of depression severity; scores range from 0-30, with higher scores indicating higher depression
Time frame: Baseline to 12-week endpoint
Self-report measure of anxiety severity; scores range from 0-21, with higher scoring indicating more anxiety
Butler Hospital
Other
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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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