Development of a Lifestyle Physical Activity Intervention to Reduce Risk for Perinatal Cannabis Use - RCT
- Conditions
- Pregnancy
- Interventions
- Behavioral: Fitbit OnlyBehavioral: LPA+Fitbit Intervention
- Registration Number
- NCT06239701
- Lead Sponsor
- Butler Hospital
- 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.
- Detailed Description
In the pilot RCT, we will recruit 50 women between 12-22 weeks gestation from an established network of prenatal clinics, and randomly assign eligible women to either a: 1) LPA+Fitbit intervention or 2) Fitbit Only control condition. Similar to our prior trials with pregnant women, the intervention period will be 12 weeks in duration during pregnancy, with follow-ups extending to the end of pregnancy and into the postpartum period. Major assessments will occur at baseline, end of treatment (EOT), and 4 weeks postpartum; we will also conduct brief phone surveys at three points in between the larger assessments. Participants will complete a 7-day period of accelerometry and urine toxicology screens following each major assessments. Birth record abstractions to collect information about specific outcomes (pre-term delivery, low birth weight) will be conducted by trained staff at one month post-birth.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 50
- women 18+ years of age
- 12-25 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Only Fitbit Fitbit Only The Fitbit Only condition will include 3 components: 1. In-person Fitbit Orientation. 2. Fitbit Activity Tracker. 3. Brief Telephone Check-ins. LPA and Fitbit LPA+Fitbit Intervention 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.
- Primary Outcome Measures
Name Time Method Activity Minutes/Day Baseline to 12-week endpoint objectively-measured
The Daily Sessions, Frequency & Quantity of Cannabis Use Inventory - Factor 1 Baseline to 12-week endpoint Self-reported cannabis use questionnaire -factor 1: daily sessions
The Daily Sessions, Frequency & Quantity of Cannabis Use Inventory - Factor 4 Baseline to 12-week endpoint Self-reported cannabis use questionnaire - factor 4: Marijuana quantity
The Daily Sessions, Frequency & Quantity of Cannabis Use Inventory - Factor 5 Baseline to 12-week endpoint Self-reported cannabis use questionnaire - factor 5: Concentrate quantity
Steps/day Baseline to 12-week endpoint objectively-measured
The Daily Sessions, Frequency & Quantity of Cannabis Use Inventory - Factor 2 Baseline to 12-week endpoint Self-reported cannabis use questionnaire - factor 2: frequency
The Daily Sessions, Frequency & Quantity of Cannabis Use Inventory - Factor 3 Baseline to 12-week endpoint Self-reported cannabis use questionnaire - factor 3: age of onset
The Daily Sessions, Frequency & Quantity of Cannabis Use Inventory - Factor 6 Baseline to 12-week endpoint Self-reported cannabis use questionnaire - factor 6: Edibles quantity
Urine Toxicology Screen Baseline to 12-week endpoint Objective screening for use of cannabis via measurement of THC in urine samples
Timeline Follow-back (TLFB) Baseline to 12-week endpoint Interviewer-administered assessment of use of cannabis, alcohol, tobacco, and other drugs
International Physical Activity Questionnaire Baseline to 12-week endpoint self-report measure of physical activity including minutes/week spent walking, engaging in moderate physical activity, and engaging in vigorous physical activity
- Secondary Outcome Measures
Name Time Method Marijuana Self-Efficacy Questionnaire Baseline to 12-week endpoint Self-report measure of efficacy for cannabis abstinence; Scores range from 0-100, with higher scores indicating greater use of strategies to reduce marijuana consumption.
Generalized Anxiety Disorder -7 Baseline to 12-week endpoint Self-report measure of anxiety severity; scores range from 0-21, with higher scoring indicating more anxiety
Brief COPE Baseline to 12-week endpoint Self-report measure of use of coping strategies; includes 14 2-item scales, each ranging from 2-8. Higher scores indicate increased utilization of a coping strategy.
Edinburgh Postnatal Depression Screen Baseline to 12-week endpoint Self-report measure of depression severity; scores range from 0-30, with higher scores indicating higher depression
Trial Locations
- Locations (1)
Butler Hospital
🇺🇸Providence, Rhode Island, United States