Clinical trial NCT05528380: Development of a Lifestyle Physical Activity Intervention to Reduce Risk for Perinatal Cannabis Use
Official title: Development of a Lifestyle Physical Activity Intervention to Reduce Risk for Perinatal Cannabis Use
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnancy
Cannabis
Lead sponsor: Butler Hospital
Sponsor class: OTHER
First posted: 2022-09-06
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Timeline Follow-back (TLFB)
timeFrame: Baseline to 12-week endpoint
measure: Steps/day
timeFrame: Baseline to 12-week endpoint
measure: Activity Minutes/Day
timeFrame: Baseline to 12-week endpoint
measure: The Daily Sessions, Frequency & Quantity of Cannabis Use Inventory - Factor 1
timeFrame: Baseline to 12-week endpoint
measure: The Daily Sessions, Frequency & Quantity of Cannabis Use Inventory - Factor 2
timeFrame: Baseline to 12-week endpoint
measure: The Daily Sessions, Frequency & Quantity of Cannabis Use Inventory - Factor 3
timeFrame: Baseline to 12-week endpoint
measure: The Daily Sessions, Frequency & Quantity of Cannabis Use Inventory - Factor 4
timeFrame: Baseline to 12-week endpoint
measure: The Daily Sessions, Frequency & Quantity of Cannabis Use Inventory - Factor 5
timeFrame: Baseline to 12-week endpoint
measure: The Daily Sessions, Frequency & Quantity of Cannabis Use Inventory - Factor 6
timeFrame: Baseline to 12-week endpoint
measure: Urine Toxicology Screen
timeFrame: Baseline to 12-week endpoint
measure: International Physical Activity Questionnaire
timeFrame: Baseline to 12-week endpoint
Secondary outcomes:
measure: Brief COPE
timeFrame: Baseline to 12-week endpoint
measure: Marijuana Self-Efficacy Questionnaire
timeFrame: Baseline to 12-week endpoint
measure: Edinburgh Postnatal Depression Screen
timeFrame: Baseline to 12-week endpoint
measure: Generalized Anxiety Disorder -7
timeFrame: Baseline to 12-week endpoint
Other outcomes:
Locations:
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
Study officials:
References: