Lifestyle intervention to reduce cannabis use during pregnancy
Development of a Lifestyle Physical Activity Intervention to Reduce Risk for Perinatal Cannabis Use - RCT
This study is testing a lifestyle program that uses a Fitbit to help pregnant women cut down on cannabis use and see if it leads to healthier pregnancies.
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 | NCT06239701 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to develop and evaluate a lifestyle physical activity intervention designed to reduce cannabis use among pregnant women. It will recruit 50 women between 12-22 weeks of gestation from prenatal clinics and randomly assign them to either an intervention group using a Fitbit or a control group using only the Fitbit. The intervention lasts for 12 weeks, with follow-ups extending into the postpartum period. Assessments will include accelerometry, urine toxicology screens, and birth record abstractions to evaluate outcomes such as pre-term delivery and low birth weight.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older, between 12-25 weeks gestation, who self-report cannabis use and wish to reduce or discontinue it.
Not a fit: Patients with a current diagnosis of moderate/severe substance use disorder other than cannabis or those using illicit substances may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could help reduce cannabis use during pregnancy, leading to improved maternal and fetal health outcomes.
How similar studies have performed: While similar lifestyle interventions have shown promise in other populations, this specific approach targeting cannabis use during pregnancy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. women 18+ years of age 2. 12-25 weeks gestation with a healthy singleton pregnancy 3. medically-cleared by their prenatal provider for moderate intensity physical activity 4. 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 5. current psychological distress as defined by Edinburgh Postnatal Depression Scale score \>7 and/or Generalized Anxiety Disorder 7 score \>5) 6. English-speaking 7. owns a smartphone to enable use of the Fitbit app 8. current physical activity level does not meet public health recommendations (less than 150 minutes/week moderate intensity physical activity for the past 3 months) 9. expresses interest in reducing or discontinuing CU Exclusion Criteria: 1. current DSM-5 diagnosis of moderate/severe substance use disorder other than cannabis use disorder or nicotine use disorder 2. use of illicit substances in the last 3 months (other than cannabis) 3. acute psychotic symptoms 4. current or recent suicidality or homicidality 5. current anorexia or bulimia 6. current cognitive impairment 7. physical or medical problems that would not allow safe participation in moderate intensity physical activity 8. has plan to relocate away from the geographic area during the study intervention or assessment period 9. recently started a new form of mental health or substance use treatment within the past 4 weeks
Where this trial is running
Providence, Rhode Island
- Butler Hospital — Providence, Rhode Island, United States (Recruiting)
Study contacts
- Principal investigator: Cynthia Battle, PhD — Butler Hospital
- Study coordinator: Rita Rossi, MA
- Email: rrossi@butler.org
- Phone: 401-455-6377
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.