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

August 26, 2026 updated by: Butler Hospital
The overall goal of this pilot study is to develop and preliminarily evaluate an LPA intervention designed to reduce cannabis use during pregnancy.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Butler Hospital

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LPA and Fitbit

The 12-week LPA+Fitbit intervention consists of 3 components:

  1. In-Person LPA+Fitbit Orientation
  2. Telephone PA counseling sessions.
  3. Fitbit activity tracker.
Behavioral: LPA+Fitbit Intervention
  1. 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.
  2. 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.
  3. 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
Active Comparator: Only Fitbit

The Fitbit Only condition will include 3 components:

  1. In-person Fitbit Orientation.
  2. Fitbit Activity Tracker.
  3. Brief Telephone Check-ins.
Behavioral: Fitbit Only
  1. 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.
  2. 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.
  3. 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timeline Follow-back (TLFB)
Time Frame: Baseline to 12-week endpoint
Interviewer-administered assessment of use of cannabis, alcohol, tobacco, and other drugs
Baseline to 12-week endpoint
Steps/day
Time Frame: Baseline to 12-week endpoint
objectively-measured
Baseline to 12-week endpoint
Activity Minutes/Day
Time Frame: Baseline to 12-week endpoint
objectively-measured
Baseline to 12-week endpoint
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
Baseline to 12-week endpoint
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
Baseline to 12-week endpoint
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
Baseline to 12-week endpoint
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
Baseline to 12-week endpoint
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
Baseline to 12-week endpoint
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
Baseline to 12-week endpoint
Urine Toxicology Screen
Time Frame: Baseline to 12-week endpoint
Objective screening for use of cannabis via measurement of THC in urine samples
Baseline to 12-week endpoint
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
Baseline to 12-week endpoint

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to 12-week endpoint
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
Baseline to 12-week endpoint
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
Baseline to 12-week endpoint
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.
Baseline to 12-week endpoint

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Butler Hospital

Investigators

  • Principal Investigator: Cynthia Battle, PhD, 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 Major Dates

Study Start (Actual)

January 22, 2024

Primary Completion (Actual)

March 31, 2026

Study Completion (Estimated)

November 30, 2026

Study Registration Dates

First Submitted

January 26, 2024

First Submitted That Met QC Criteria

January 26, 2024

First Posted (Actual)

February 2, 2024

Study Record Updates

Last Update Posted (Actual)

August 28, 2026

Last Update Submitted That Met QC Criteria

August 26, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R34DA055317-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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