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

Study Overview
=================
Brief Summary
-----------------
This NIH funded study will enroll 20 pregnant women in an Open Trial and 50 pregnant women in an RCT who are at high risk for prenatal cannabis use. Participants will be assigned to either: (1) a 12-week Lifestyle Physical Activity plus Fitbit (LPA+Fitbit) intervention or (2) a Fitbit Only condition. 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.

Detailed Description
-----------------
This study will recruit 70 women who are high risk for prenatal cannabis use for a 12-week program of either using a Fitbit activity tracker or 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.

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

Conditions
-----------------
Pregnancy, Cannabis

Intervention / Treatment
-----------------
* Behavioral: LPA+Fitbit intervention
* Behavioral: Fitbit Only


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women aged 18+ 12-22 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: RCT
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LPA+Fitbit intervention<br>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. | Behavioral: LPA+Fitbit intervention<br>* Participants will receive a Fitbit to track activity an orientation and 5 intervention sessions including sessions on motivation, goal-setting, identifying and overcoming barriers, time management, and long-term maintenance of physical activity.<br>|
| Active Comparator: Fitbit Only<br>Participants will be given the same Fitbit as in the LPA condition. However, participants are not given specific step count goals to achieve during the 12-week intervention. Brief Telephone Check-ins. As with the LPA+Fitbit condition, those in the Fitbit Only condition will receive phone calls. These calls will last 5 minutes and be focused entirely on answering any problems related to the Fitbit such as syncing issues, charging the battery, and any other technical problems that may arise. No physical activity counseling will be delivered on these calls. | Behavioral: Fitbit Only<br>* Participants will receive a Fitbit to track activity, an orientation session, and 5 brief telephone check-ins, focused on addressing any problems related to the Fitbit such as syncing issues, charging the battery, and any other technical problems that may arise.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timeline Follow-back (TLFB) | Interviewer-administered assessment of use of cannabis, alcohol, tobacco, and other drugs | Baseline to 12-week endpoint | 
| Steps/day | objectively-measured | Baseline to 12-week endpoint | 
| Activity Minutes/Day | objectively-measured | Baseline to 12-week endpoint | 
| The Daily Sessions, Frequency & Quantity of Cannabis Use Inventory - Factor 1 | Self-reported cannabis use questionnaire -factor 1: daily sessions | Baseline to 12-week endpoint | 
| The Daily Sessions, Frequency & Quantity of Cannabis Use Inventory - Factor 2 | Self-reported cannabis use questionnaire - factor 2: frequency | Baseline to 12-week endpoint | 
| The Daily Sessions, Frequency & Quantity of Cannabis Use Inventory - Factor 3 | Self-reported cannabis use questionnaire - factor 3: age of onset | Baseline to 12-week endpoint | 
| The Daily Sessions, Frequency & Quantity of Cannabis Use Inventory - Factor 4 | Self-reported cannabis use questionnaire - factor 4: Marijuana quantity | Baseline to 12-week endpoint | 
| The Daily Sessions, Frequency & Quantity of Cannabis Use Inventory - Factor 5 | Self-reported cannabis use questionnaire - factor 5: Concentrate quantity | Baseline to 12-week endpoint | 
| The Daily Sessions, Frequency & Quantity of Cannabis Use Inventory - Factor 6 | Self-reported cannabis use questionnaire - factor 6: Edibles quantity | Baseline to 12-week endpoint | 
| Urine Toxicology Screen | Objective screening for use of cannabis via measurement of THC in urine samples | Baseline to 12-week endpoint | 
| International Physical Activity Questionnaire | self-report measure of physical activity including minutes/week spent walking, engaging in moderate physical activity, and engaging in vigorous physical activity | Baseline to 12-week endpoint | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief COPE | Self-report measure of of use of coping strategies; includes 14 2-item scales, each ranging form 2-8. Higher scores indicate increased utilization of a coping strategy. | Baseline to 12-week endpoint | 
| Marijuana Self-Efficacy Questionnaire | 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. | Baseline to 12-week endpoint | 
| Edinburgh Postnatal Depression Screen | Self-report measure of depression severity; scores range from 0-30, with higher scores indicating higher depression | Baseline to 12-week endpoint | 
| Generalized Anxiety Disorder -7 | Self-report measure of anxiety severity; scores range from 0-21, with higher scoring indicating more anxiety | Baseline to 12-week endpoint |