Development of a Lifestyle Physical Activity Intervention to Reduce Risk for Perinatal Cannabis Use - RCT
Overview
- Phase
- N/A
- Intervention
- LPA+Fitbit Intervention
- Conditions
- Pregnancy
- Sponsor
- Butler Hospital
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Activity Minutes/Day
- Status
- Active, Not Recruiting
- Last Updated
- 2 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
LPA and Fitbit
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.
Intervention: LPA+Fitbit Intervention
Only Fitbit
The Fitbit Only condition will include 3 components: 1. In-person Fitbit Orientation. 2. Fitbit Activity Tracker. 3. Brief Telephone Check-ins.
Intervention: Fitbit Only
Outcomes
Primary Outcomes
Activity Minutes/Day
Time Frame: Baseline to 12-week endpoint
objectively-measured
The Daily Sessions, Frequency & Quantity of Cannabis Use Inventory - Factor 1
Time Frame: 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
Time Frame: 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
Time Frame: Baseline to 12-week endpoint
Self-reported cannabis use questionnaire - factor 5: Concentrate quantity
Steps/day
Time Frame: Baseline to 12-week endpoint
objectively-measured
The Daily Sessions, Frequency & Quantity of Cannabis Use Inventory - Factor 2
Time Frame: Baseline to 12-week endpoint
Self-reported cannabis use questionnaire - factor 2: frequency
The Daily Sessions, Frequency & Quantity of Cannabis Use Inventory - Factor 3
Time Frame: 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
Time Frame: Baseline to 12-week endpoint
Self-reported cannabis use questionnaire - factor 6: Edibles quantity
Urine Toxicology Screen
Time Frame: Baseline to 12-week endpoint
Objective screening for use of cannabis via measurement of THC in urine samples
Timeline Follow-back (TLFB)
Time Frame: Baseline to 12-week endpoint
Interviewer-administered assessment of use of cannabis, alcohol, tobacco, and other drugs
International Physical Activity Questionnaire
Time Frame: 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 Outcomes
- Marijuana Self-Efficacy Questionnaire(Baseline to 12-week endpoint)
- Generalized Anxiety Disorder -7(Baseline to 12-week endpoint)
- Brief COPE(Baseline to 12-week endpoint)
- Edinburgh Postnatal Depression Screen(Baseline to 12-week endpoint)