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

NCT06239701 | Active Not Recruiting DMC

• 1 other identifier: R34DA055317-02
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (11)

• Timeline Follow-back (TLFB)

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

  Baseline to 12-week endpoint

• Steps/day

  objectively-measured

  Baseline to 12-week endpoint

• Activity Minutes/Day

  objectively-measured

  Baseline to 12-week endpoint

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

  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

  Self-reported cannabis use questionnaire - factor 2: frequency

  Baseline to 12-week endpoint

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

  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

  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

  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

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

  Baseline to 12-week endpoint

• Urine Toxicology Screen

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

  Baseline to 12-week endpoint

• International Physical Activity Questionnaire

  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 Outcomes (4)

• Brief COPE

  Baseline to 12-week endpoint

• Marijuana Self-Efficacy Questionnaire

  Baseline to 12-week endpoint

• Edinburgh Postnatal Depression Screen

  Baseline to 12-week endpoint

• Generalized Anxiety Disorder -7

  Baseline to 12-week endpoint

Study Arms (2)

LPA and Fitbit

EXPERIMENTAL

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

Only Fitbit

ACTIVE COMPARATOR

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

Interventions

LPA+Fitbit Intervention BEHAVIORAL

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.

Also known as: Women Out Walking

LPA and Fitbit

Fitbit Only BEHAVIORAL

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.

Only Fitbit

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• women 18+ years of age
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Butler Hospital: lead

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

Study Officials

• Cynthia Battle, PhD

  Butler Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to either a Fitbit Only Condition, or a Fitbit + A Lifestyle Physical Activity Intervention.

Study Record Dates

• First Submitted: January 26, 2024
• First Posted: February 2, 2024
• Study Start: January 22, 2024
• Primary Completion: March 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)