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

Butler Hospital50 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pregnancy Cannabis

Interventions

LPA + Fitbit InterventionBEHAVIORAL

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 OnlyBEHAVIORAL

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.

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Butler Hospital

Providence, Rhode Island, United States

RECRUITING