Back to resultsDevelopment of a Lifestyle Physical Activity Intervention to Reduce Risk for Perinatal Cannabis Use
Primary Purpose
Pregnancy, Cannabis
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LPA+Fitbit intervention
Fitbit Only
Sponsored by
About this trial
This is an interventional treatment trial for Pregnancy
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.
Sites / Locations
- Butler HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
LPA+Fitbit intervention
Fitbit Only
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Timeline Follow-back (TLFB)
Interviewer-administered assessment of use of cannabis, alcohol, tobacco, and other drugs
Steps/day
objectively-measured
Activity Minutes/Day
objectively-measured
The Daily Sessions, Frequency & Quantity of Cannabis Use Inventory - Factor 1
Self-reported cannabis use questionnaire -factor 1: daily sessions
The Daily Sessions, Frequency & Quantity of Cannabis Use Inventory - Factor 2
Self-reported cannabis use questionnaire - factor 2: frequency
The Daily Sessions, Frequency & Quantity of Cannabis Use Inventory - Factor 3
Self-reported cannabis use questionnaire - factor 3: age of onset
The Daily Sessions, Frequency & Quantity of Cannabis Use Inventory - Factor 4
Self-reported cannabis use questionnaire - factor 4: Marijuana quantity
The Daily Sessions, Frequency & Quantity of Cannabis Use Inventory - Factor 5
Self-reported cannabis use questionnaire - factor 5: Concentrate quantity
The Daily Sessions, Frequency & Quantity of Cannabis Use Inventory - Factor 6
Self-reported cannabis use questionnaire - factor 6: Edibles quantity
Urine Toxicology Screen
Objective screening for use of cannabis via measurement of THC in urine samples
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
Secondary Outcome Measures
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.
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.
Edinburgh Postnatal Depression Screen
Self-report measure of depression severity; scores range from 0-30, with higher scores indicating higher depression
Generalized Anxiety Disorder -7
Self-report measure of anxiety severity; scores range from 0-21, with higher scoring indicating more anxiety
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05528380
Brief Title
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
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 30, 2022 (Actual)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Butler Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, Cannabis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
RCT
Masking
Outcomes Assessor
Masking Description
Outcomes assessor will be blind to condition assignment.
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
LPA+Fitbit intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Fitbit Only
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
LPA+Fitbit intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Fitbit Only
Intervention Description
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.
Primary Outcome Measure Information:
Title
Timeline Follow-back (TLFB)
Description
Interviewer-administered assessment of use of cannabis, alcohol, tobacco, and other drugs
Time Frame
Baseline to 12-week endpoint
Title
Steps/day
Description
objectively-measured
Time Frame
Baseline to 12-week endpoint
Title
Activity Minutes/Day
Description
objectively-measured
Time Frame
Baseline to 12-week endpoint
Title
The Daily Sessions, Frequency & Quantity of Cannabis Use Inventory - Factor 1
Description
Self-reported cannabis use questionnaire -factor 1: daily sessions
Time Frame
Baseline to 12-week endpoint
Title
The Daily Sessions, Frequency & Quantity of Cannabis Use Inventory - Factor 2
Description
Self-reported cannabis use questionnaire - factor 2: frequency
Time Frame
Baseline to 12-week endpoint
Title
The Daily Sessions, Frequency & Quantity of Cannabis Use Inventory - Factor 3
Description
Self-reported cannabis use questionnaire - factor 3: age of onset
Time Frame
Baseline to 12-week endpoint
Title
The Daily Sessions, Frequency & Quantity of Cannabis Use Inventory - Factor 4
Description
Self-reported cannabis use questionnaire - factor 4: Marijuana quantity
Time Frame
Baseline to 12-week endpoint
Title
The Daily Sessions, Frequency & Quantity of Cannabis Use Inventory - Factor 5
Description
Self-reported cannabis use questionnaire - factor 5: Concentrate quantity
Time Frame
Baseline to 12-week endpoint
Title
The Daily Sessions, Frequency & Quantity of Cannabis Use Inventory - Factor 6
Description
Self-reported cannabis use questionnaire - factor 6: Edibles quantity
Time Frame
Baseline to 12-week endpoint
Title
Urine Toxicology Screen
Description
Objective screening for use of cannabis via measurement of THC in urine samples
Time Frame
Baseline to 12-week endpoint
Title
International Physical Activity Questionnaire
Description
self-report measure of physical activity including minutes/week spent walking, engaging in moderate physical activity, and engaging in vigorous physical activity
Time Frame
Baseline to 12-week endpoint
Secondary Outcome Measure Information:
Title
Brief COPE
Description
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.
Time Frame
Baseline to 12-week endpoint
Title
Marijuana Self-Efficacy Questionnaire
Description
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.
Time Frame
Baseline to 12-week endpoint
Title
Edinburgh Postnatal Depression Screen
Description
Self-report measure of depression severity; scores range from 0-30, with higher scores indicating higher depression
Time Frame
Baseline to 12-week endpoint
Title
Generalized Anxiety Disorder -7
Description
Self-report measure of anxiety severity; scores range from 0-21, with higher scoring indicating more anxiety
Time Frame
Baseline to 12-week endpoint
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rita Rossi, MA
Phone
455-6377
Email
Rita_Rossi@brown.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Cynthia Battle, PhD
Phone
401-455-6371
Email
Cynthia_Battle@brown.edu
Facility Information:
Facility Name
Butler Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cynthia Battle, PhD
Phone
401-455-6377
First Name & Middle Initial & Last Name & Degree
Rita Rossi, MA
Phone
401-455-6377
12. IPD Sharing Statement
Learn more about this trial
Development of a Lifestyle Physical Activity Intervention to Reduce Risk for Perinatal Cannabis Use
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