RECRUITING

Development of a Lifestyle Physical Activity Intervention to Reduce Risk for Perinatal Cannabis Use

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Development of a Lifestyle Physical Activity Intervention to Reduce Risk for Perinatal Cannabis Use

Quick Facts

Study Start:2022-01-30
Study Completion:2025-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05528380

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Women aged 18+
  2. * 12-25 weeks gestation with a healthy singleton pregnancy
  3. * Medically cleared for moderate physical activity
  4. * 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
  5. * Elevated depression (EPDS\>=7) or anxiety (GAD7\>=5)
  6. * English-speaking
  7. * Owns a smartphone to enable use of the Fitbit app
  8. * Current physical activity does not meet health recommendations (150 min/week mod intensity activity)
  9. * Expresses interest in reducing or discontinuing cannabis use
  1. * Current DSM-5 diagnosis of moderate/severe substance use disorder other than CUD 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 homicidally
  5. * Current anorexia or bulimia
  6. * Cognitive impairment
  7. * Physical or medical problems that would not allow safe participation in moderate intensity PA (i.e., not medical cleared by Ob/Gyn)
  8. * Has a plan to relocate away from the area during study period
  9. * Recently started new mental health or substance use treatment within past 4 weeks.

Contacts and Locations

Study Contact

Rita Rossi, MA
CONTACT
455-6377
Rita_Rossi@brown.edu
Cynthia Battle, PhD
CONTACT
401-455-6371
Cynthia_Battle@brown.edu

Study Locations (Sites)

Butler Hospital
Providence, Rhode Island, 02906
United States

Collaborators and Investigators

Sponsor: Butler Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-01-30
Study Completion Date2025-05

Study Record Updates

Study Start Date2022-01-30
Study Completion Date2025-05

Terms related to this study

Additional Relevant MeSH Terms

  • Pregnancy
  • Cannabis