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Active, Not Recruiting

NCT Number: NCT06239701

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Pregnancy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Butler Hospital

Providence, Rhode Island, 02906, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • women 18+ years of age
  • 12-25 weeks gestation with a healthy singleton pregnancy
  • medically-cleared by their prenatal provider for moderate intensity physical activity
  • 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
  • current psychological distress as defined by Edinburgh Postnatal Depression Scale score >7 and/or Generalized Anxiety Disorder 7 score >5)
  • English-speaking
  • owns a smartphone to enable use of the Fitbit app
  • current physical activity level does not meet public health recommendations (less than 150 minutes/week moderate intensity physical activity for the past 3 months)
  • expresses interest in reducing or discontinuing CU

Exclusion criteria

  • current DSM-5 diagnosis of moderate/severe substance use disorder other than cannabis use disorder or nicotine use disorder
  • use of illicit substances in the last 3 months (other than cannabis)
  • acute psychotic symptoms
  • current or recent suicidality or homicidality
  • current anorexia or bulimia
  • current cognitive impairment
  • physical or medical problems that would not allow safe participation in moderate intensity physical activity
  • has plan to relocate away from the geographic area during the study intervention or assessment period
  • recently started a new form of mental health or substance use treatment within the past 4 weeks

Treatment and study plan

LPA+Fitbit Intervention

Behavioral
  • In-Person LPA+Fitbit Orientation. During an initial, orientation (45 minutes), a study interventionist will provide information regarding the acute and long-term psychological and physical benefits of increasing PA, including prenatally.
  • Telephone PA counseling sessions. A study interventionist will call participants at weeks 2, 4, 6, 8, and 10 of the intervention for a 20-min telephone session.
  • Fitbit activity tracker. With participant permission, a Fitbit account (on Fitbit.com) and study-generated password will be created. In doing so, investigators will have access to the participant activity data throughout the intervention. The Fitbit web-based and mobile apps facilitate goal-setting by allowing participants to easily set goals and change these goals at any point. We will customize each participant account to display daily steps and very active minutes, though they will be encouraged to adjust the display according to their preferences.

Other names: Women Out Walking

Fitbit Only

Behavioral
  • In-person Fitbit Orientation. Participants will be given information on the public health guidelines for PA during pregnancy, and as well as how to determine if their PA is moderate-intensity. In addition, interventionists will orient participants to the proper use of the Fitbit tracker and offer tips for self-monitoring step counts with the tracker and on the app.
  • Fitbit Activity Tracker. Participants will be given the same Fitbit as in the LPA condition. Participants will not be given any specific step count goals to achieve during the 12-week intervention.
  • Brief Telephone Check-ins. As with the LPA+Fitbit participants, those in the Fitbit Only condition will receive phone calls on weeks 2, 4, 6, 8, 10. These calls will last 5 minutes and be focused entirely on answering any problems related to the Fitbit such as syncing issues, charging the battery, and any other technical problems that may arise. No physical activity counseling will be delivered on these calls.

Primary outcomes

  1. Timeline Follow-back (TLFB)

    Time frame: Baseline to 12-week endpoint

    Interviewer-administered assessment of use of cannabis, alcohol, tobacco, and other drugs

  2. Steps/day

    Time frame: Baseline to 12-week endpoint

    objectively-measured

  3. Activity Minutes/Day

    Time frame: Baseline to 12-week endpoint

    objectively-measured

  4. The Daily Sessions, Frequency & Quantity of Cannabis Use Inventory - Factor 1

    Time frame: Baseline to 12-week endpoint

    Self-reported cannabis use questionnaire -factor 1: daily sessions

  5. The Daily Sessions, Frequency & Quantity of Cannabis Use Inventory - Factor 2

    Time frame: Baseline to 12-week endpoint

    Self-reported cannabis use questionnaire - factor 2: frequency

  6. The Daily Sessions, Frequency & Quantity of Cannabis Use Inventory - Factor 3

    Time frame: Baseline to 12-week endpoint

    Self-reported cannabis use questionnaire - factor 3: age of onset

  7. The Daily Sessions, Frequency & Quantity of Cannabis Use Inventory - Factor 4

    Time frame: Baseline to 12-week endpoint

    Self-reported cannabis use questionnaire - factor 4: Marijuana quantity

  8. The Daily Sessions, Frequency & Quantity of Cannabis Use Inventory - Factor 5

    Time frame: Baseline to 12-week endpoint

    Self-reported cannabis use questionnaire - factor 5: Concentrate quantity

  9. The Daily Sessions, Frequency & Quantity of Cannabis Use Inventory - Factor 6

    Time frame: Baseline to 12-week endpoint

    Self-reported cannabis use questionnaire - factor 6: Edibles quantity

  10. Urine Toxicology Screen

    Time frame: Baseline to 12-week endpoint

    Objective screening for use of cannabis via measurement of THC in urine samples

  11. International Physical Activity Questionnaire

    Time frame: Baseline to 12-week endpoint

    self-report measure of physical activity including minutes/week spent walking, engaging in moderate physical activity, and engaging in vigorous physical activity

Secondary outcomes

  1. Brief COPE

    Time frame: Baseline to 12-week endpoint

    Self-report measure of use of coping strategies; includes 14 2-item scales, each ranging from 2-8. Higher scores indicate increased utilization of a coping strategy.

  2. Marijuana Self-Efficacy Questionnaire

    Time frame: Baseline to 12-week endpoint

    Self-report measure of efficacy for cannabis abstinence; Scores range from 0-100, with higher scores indicating greater use of strategies to reduce marijuana consumption.

  3. Edinburgh Postnatal Depression Screen

    Time frame: Baseline to 12-week endpoint

    Self-report measure of depression severity; scores range from 0-30, with higher scores indicating higher depression

  4. Generalized Anxiety Disorder -7

    Time frame: Baseline to 12-week endpoint

    Self-report measure of anxiety severity; scores range from 0-21, with higher scoring indicating more anxiety

Sponsors and collaborators

Lead sponsor

Butler Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 2, 2024
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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