Development of a Lifestyle Physical Activity Intervention to Reduce Risk for Perinatal Cannabis U… (NCT06239701) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Development of a Lifestyle Physical Activity Intervention to Reduce Risk for Perinatal Cannabis Use - RCT
United States50 participantsStarted 2024-01-22
Plain-language summary
The overall goal of this pilot study is to develop and preliminarily evaluate an LPA intervention designed to reduce cannabis use during pregnancy.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. women 18+ years of age
. 12-25 weeks gestation with a healthy singleton pregnancy
. medically-cleared by their prenatal provider for moderate intensity physical activity
. self-report of cannabis use at least once/week in the 3 months prior to the current pregnancy and desire to not engage in prenatal CU
. current psychological distress as defined by Edinburgh Postnatal Depression Scale score \>7 and/or Generalized Anxiety Disorder 7 score \>5)
. English-speaking
. owns a smartphone to enable use of the Fitbit app
. current physical activity level does not meet public health recommendations (less than 150 minutes/week moderate intensity physical activity for the past 3 months)
Exclusion criteria
. current DSM-5 diagnosis of moderate/severe substance use disorder other than cannabis use disorder or nicotine use disorder
. use of illicit substances in the last 3 months (other than cannabis)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Timeline Follow-back (TLFB)
Timeframe: Baseline to 12-week endpoint
2
Steps/day
Timeframe: Baseline to 12-week endpoint
3
Activity Minutes/Day
Timeframe: Baseline to 12-week endpoint
4
The Daily Sessions, Frequency & Quantity of Cannabis Use Inventory - Factor 1
Timeframe: Baseline to 12-week endpoint
5
The Daily Sessions, Frequency & Quantity of Cannabis Use Inventory - Factor 2
Timeframe: Baseline to 12-week endpoint
6
The Daily Sessions, Frequency & Quantity of Cannabis Use Inventory - Factor 3
Timeframe: Baseline to 12-week endpoint
7
The Daily Sessions, Frequency & Quantity of Cannabis Use Inventory - Factor 4