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: from week 6 to the end of the intervention at week 12
Number of participants using cannabis at week 12, assessed via the Timeline Follow Back
Time frame: Baseline to 12-week endpoint
objectively-measured via wearable device
Time frame: Baseline to 12-week endpoint
Number who reported walking 4 or more days/week for 10 or more continuous minutes per day
Time frame: past week, assessed at week 12 (end of intervention)
Self-report measure of depression severity; scores range from 0-30, with higher scores indicating more severe depression
Time frame: past 2 weeks, assessed at week 12 (end of intervention)
Self-report measure of anxiety severity; scores range from 0-21, with higher scoring indicating more severe anxiety
Time frame: Week 12 End of Treatment (EOT)
The Client Satisfaction Questionnaire is an 8 item survey of participant satisfaction. Scores range from 8-32; higher scores indicate higher satisfaction.
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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