Program to help pregnant women reduce cannabis use through physical activity
Development of a Lifestyle Physical Activity Intervention to Reduce Risk for Perinatal Cannabis Use
This study is testing whether a 12-week program that encourages physical activity can help pregnant women cut down on cannabis use and improve their mental health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Butler Hospital Academic / other |
| Locations | 1 site (Providence, Rhode Island) |
| Trial ID | NCT05528380 on ClinicalTrials.gov |
What this trial studies
This intervention recruits 20 women who are at high risk for prenatal cannabis use to participate in a 12-week program that combines the use of a Fitbit activity tracker with a Lifestyle Physical Activity program. Participants will self-report their cannabis use and physical activity levels, while also being monitored for symptoms of depression and anxiety. The study aims to promote physical activity as a means to reduce cannabis use and improve overall mental health during pregnancy. Follow-up assessments will be conducted postpartum to evaluate the long-term effects of the intervention.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older, between 12-25 weeks of gestation, who have a healthy singleton pregnancy and a history of cannabis use.
Not a fit: Patients with severe substance use disorders, acute psychotic symptoms, or significant cognitive impairments may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this program could help pregnant women reduce their cannabis use, leading to improved health outcomes for both mothers and their babies.
How similar studies have performed: While similar lifestyle interventions have shown promise in other populations, this specific approach targeting prenatal cannabis use is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
Where this trial is running
Providence, Rhode Island
- Butler Hospital — Providence, Rhode Island, United States (Recruiting)
Study contacts
- Study coordinator: Rita Rossi, MA
- Email: Rita_Rossi@brown.edu
- Phone: 455-6377
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.