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

Last updated: July 16, 2025
Sponsor: Butler Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pregnancy

Substance Abuse

Treatment

Fitbit Only

LPA+Fitbit Intervention

Clinical Study ID

NCT06239701
R34DA055317-02
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

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 physicalactivity

  4. self-report of cannabis use at least once/week in the 3 months prior to the currentpregnancy and desire to not engage in prenatal CU

  5. current psychological distress as defined by Edinburgh Postnatal Depression Scalescore >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 (lessthan 150 minutes/week moderate intensity physical activity for the past 3 months)

  9. expresses interest in reducing or discontinuing CU

Exclusion

Exclusion Criteria:

  1. current DSM-5 diagnosis of moderate/severe substance use disorder other thancannabis 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 moderateintensity physical activity

  8. has plan to relocate away from the geographic area during the study intervention orassessment period

  9. recently started a new form of mental health or substance use treatment within thepast 4 weeks

Study Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: Fitbit Only
Phase:
Study Start date:
January 22, 2024
Estimated Completion Date:
February 28, 2026

Study Description

In the pilot RCT, we will recruit 50 women between 12-22 weeks gestation from an established network of prenatal clinics, and randomly assign eligible women to either a:

  1. LPA+Fitbit intervention or 2) Fitbit Only control condition. Similar to our prior trials with pregnant women, the intervention period will be 12 weeks in duration during pregnancy, with follow-ups extending to the end of pregnancy and into the postpartum period. Major assessments will occur at baseline, end of treatment (EOT), and 4 weeks postpartum; we will also conduct brief phone surveys at three points in between the larger assessments. Participants will complete a 7-day period of accelerometry and urine toxicology screens following each major assessments. Birth record abstractions to collect information about specific outcomes (pre-term delivery, low birth weight) will be conducted by trained staff at one month post-birth.

Connect with a study center

  • Butler Hospital

    Providence, Rhode Island 02906
    United States

    Active - Recruiting

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