RECRUITING

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

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Conditions

Pregnancy

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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

The overall goal of this pilot study is to develop and preliminarily evaluate an LPA intervention designed to reduce cannabis use during pregnancy.

Official Title

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

Quick Facts

Study Start:2024-01-22
Study Completion:2025-05-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06239701

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. 1. women 18+ years of age
  2. 2. 12-25 weeks gestation with a healthy singleton pregnancy
  3. 3. medically-cleared by their prenatal provider for moderate intensity physical activity
  4. 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. 5. current psychological distress as defined by Edinburgh Postnatal Depression Scale score \>7 and/or Generalized Anxiety Disorder 7 score \>5)
  6. 6. English-speaking
  7. 7. owns a smartphone to enable use of the Fitbit app
  8. 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. 9. expresses interest in reducing or discontinuing CU
  1. 1. current DSM-5 diagnosis of moderate/severe substance use disorder other than cannabis use disorder or nicotine use disorder
  2. 2. use of illicit substances in the last 3 months (other than cannabis)
  3. 3. acute psychotic symptoms
  4. 4. current or recent suicidality or homicidality
  5. 5. current anorexia or bulimia
  6. 6. current cognitive impairment
  7. 7. physical or medical problems that would not allow safe participation in moderate intensity physical activity
  8. 8. has plan to relocate away from the geographic area during the study intervention or assessment period
  9. 9. recently started a new form of mental health or substance use treatment within the past 4 weeks

Contacts and Locations

Study Contact

Rita Rossi, MA
CONTACT
401-455-6377
rrossi@butler.org
Cynthia Battle, PhD
CONTACT
401-4556371
cynthia_battle@brown.edu

Principal Investigator

Cynthia Battle, PhD
PRINCIPAL_INVESTIGATOR
Butler Hospital

Study Locations (Sites)

Butler Hospital
Providence, Rhode Island, 02906
United States

Collaborators and Investigators

Sponsor: Butler Hospital

  • Cynthia Battle, PhD, PRINCIPAL_INVESTIGATOR, 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 Date2024-01-22
Study Completion Date2025-05-30

Study Record Updates

Study Start Date2024-01-22
Study Completion Date2025-05-30

Terms related to this study

Additional Relevant MeSH Terms

  • Pregnancy