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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05528380
• Other study ID #: 1R34DA055317-01A1
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 30, 2022
• Est. completion date: May 2025

Study information

• Verified date: January 2024
• Source: Butler Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 16
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cannabis
• Marijuana Abuse
• Pregnancy

Intervention

Behavioral:
• LPA + Fitbit Intervention
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.

Locations

Country	Name	City	State
United States	Butler Hospital	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Butler Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Timeline Follow-back (TLFB)	Interviewer-administered assessment of use of cannabis, alcohol, tobacco, and other drugs	Baseline to 12-week endpoint
Primary	Steps/day	objectively-measured	Baseline to 12-week endpoint
Primary	Activity Minutes/Day	objectively-measured	Baseline to 12-week endpoint
Primary	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
Primary	The Daily Sessions, Frequency & Quantity of Cannabis Use Inventory - Factor 2	Self-reported cannabis use questionnaire - factor 2: frequency	Baseline to 12-week endpoint
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Urine Toxicology Screen	Objective screening for use of cannabis via measurement of THC in urine samples	Baseline to 12-week endpoint
Primary	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	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
Secondary	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
Secondary	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
Secondary	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