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

Butler Hospital

Status: Enrolling

Conditions: Cannabis; Pregnancy

Treatments: Behavioral: LPA + Fitbit Intervention; Behavioral: Fitbit Only

Study type: Interventional

Funder types: Other

Identifiers

NCT05528380

1R34DA055317-01A1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

RCT Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: LPA + Fitbit Intervention

Fitbit Only

Active Comparator group

Description:

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.

Treatment:

Behavioral: Fitbit Only