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

NCT ID: NCT05528380

Last Updated: 2025-07-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-30
• Study Completion Date: 2026-02-28

Brief Summary

This study will recruit 20 women who are high risk for prenatal cannabis use for a 12-week program of using the tracker and receiving a Lifestyle Physical Activity program. The primary outcomes will be self reported percent days of cannabis use and physical activity. Secondary outcomes include self -reported measures of depression and anxiety symptoms, adaptive coping, and self-efficacy for cannabis abstinence.

Detailed Description

This study will recruit 20 women in an open trial who are high risk for prenatal cannabis use for a 12-week program of using a Fitbit activity tracker and receiving a Lifestyle Physical Activity program. The primary outcomes will be self reported percent days of cannabis use and physical activity. Secondary outcomes include self -reported measures of depression and anxiety symptoms, adaptive coping, and self-efficacy for cannabis abstinence. The investigators will clinically monitor all participants in the study for safety and clinical deterioration, and measure a variety of symptom outcomes over the course of the intervention period during pregnancy, as well as at a postpartum follow-up.

Conditions

Pregnancy; Cannabis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RCT Intervention

In the Open Trial all participants received a Fitbit to track activity levels and participate in a 6-session lifestyle physical activity intervention over the course of 12 weeks. The intervention consists of 20-25 minute phone or video-delivered session to: (a) review PA progress and re-evaluate current step-count goals, (b) problem-solve barriers to incorporating PA into their daily lives, (c) address difficulties utilizing the Fitbit, (d) encourage the use of bouts of PA as a coping strategy, and e) engage the participant in brief discussions focused on increasing and maintaining PA.

Group Type: EXPERIMENTAL

LPA + Fitbit Intervention

Intervention Type: BEHAVIORAL

Participants will receive a Fitbit to track activity levels and participate in a 6-session lifestyle physical activity intervention over the course of 12 weeks. The intervention consists of 20-25 minute phone or video-delivered session to: (a) review PA progress and re-evaluate current step-count goals, (b) problem-solve barriers to incorporating PA into their daily lives, (c) address difficulties utilizing the Fitbit, (d) encourage the use of bouts of PA as a coping strategy, and e) engage the participant in brief discussions focused on increasing and maintaining PA.

Fitbit Only

Participants randomly assigned to this are will receive a Fitbit to track activity levels and participate in 6 brief check-ins to assess any issues with the Fitbit device or app.

Group Type: ACTIVE_COMPARATOR

Fitbit Only

Intervention Type: BEHAVIORAL

Participants will receive a Fitbit to track activity levels and participate in 6 brief check-ins to assess any issues with the Fitbit device or app.

Interventions

LPA + Fitbit Intervention

Participants will receive a Fitbit to track activity levels and participate in a 6-session lifestyle physical activity intervention over the course of 12 weeks. The intervention consists of 20-25 minute phone or video-delivered session to: (a) review PA progress and re-evaluate current step-count goals, (b) problem-solve barriers to incorporating PA into their daily lives, (c) address difficulties utilizing the Fitbit, (d) encourage the use of bouts of PA as a coping strategy, and e) engage the participant in brief discussions focused on increasing and maintaining PA.

Intervention Type: BEHAVIORAL

Fitbit Only

Participants will receive a Fitbit to track activity levels and participate in 6 brief check-ins to assess any issues with the Fitbit device or app.

Intervention Type: BEHAVIORAL

Other Intervention Names

Women Out Walking

Eligibility Criteria

Inclusion Criteria

• Women aged 18+
• 12-25 weeks gestation with a healthy singleton pregnancy
• Medically cleared for moderate physical activity
• Self-report of cannabis use at least once/week in the 3 months prior to the pregnancy desire to not engage in prenatal cannabis use
• Elevated depression (EPDS>=7) or anxiety (GAD7>=5)
• English-speaking
• Owns a smartphone to enable use of the Fitbit app
• Current physical activity does not meet health recommendations (150 min/week mod intensity activity)
• Expresses interest in reducing or discontinuing cannabis use

Exclusion Criteria

• Current DSM-5 diagnosis of moderate/severe substance use disorder other than CUD or nicotine use disorder
• Use of illicit substances in the last 3 months (other than cannabis)
• Acute psychotic symptoms
• Current or recent suicidality or homicidally
• Current anorexia or bulimia
• Cognitive impairment
• Physical or medical problems that would not allow safe participation in moderate intensity PA (i.e., not medical cleared by Ob/Gyn)
• Has a plan to relocate away from the area during study period
• Recently started new mental health or substance use treatment within past 4 weeks.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Butler Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Butler Hospital

Providence, Rhode Island, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Rita Rossi, MA

Role: CONTACT

Rita_Rossi@brown.edu

455-6377

Cynthia Battle, PhD

Role: CONTACT

Cynthia_Battle@brown.edu

401-455-6371

Facility Contacts

Cynthia Battle, PhD

Role: primary

401-455-6377

Rita Rossi, MA

Role: backup

401-455-6377

Other Identifiers

1R34DA055317-01A1

Identifier Type: NIH

Identifier Source: org_study_id

View Link