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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06239701
• Other study ID #: R34DA055317-02
• Status: Recruiting
• Phase: N/A
• Start date: January 22, 2024
• Est. completion date: May 30, 2025

Study information

• Verified date: January 2024
• Source: Butler Hospital
• Contact: Rita Rossi, MA
• Phone: 401-455-6377
• Email: rrossi[@]butler.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The overall goal of this pilot study is to develop and preliminarily evaluate an LPA intervention designed to reduce cannabis use during pregnancy.

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 information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 30, 2025
• Est. primary completion date: May 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. women 18+ years of age

2. 12-25 weeks gestation with a healthy singleton pregnancy

3. medically-cleared by their prenatal provider for moderate intensity physical activity

4. 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

5. current psychological distress as defined by Edinburgh Postnatal Depression Scale score >7 and/or Generalized Anxiety Disorder 7 score >5)

6. English-speaking

7. owns a smartphone to enable use of the Fitbit app

8. current physical activity level does not meet public health recommendations (less than 150 minutes/week moderate intensity physical activity for the past 3 months)

9. expresses interest in reducing or discontinuing CU

Exclusion Criteria:

1. current DSM-5 diagnosis of moderate/severe substance use disorder other than cannabis use disorder or nicotine use disorder

2. use of illicit substances in the last 3 months (other than cannabis)

3. acute psychotic symptoms

4. current or recent suicidality or homicidality

5. current anorexia or bulimia

6. current cognitive impairment

7. physical or medical problems that would not allow safe participation in moderate intensity physical activity

8. has plan to relocate away from the geographic area during the study intervention or assessment period

9. recently started a new form of mental health or substance use treatment within the past 4 weeks

Related Conditions & MeSH terms

• Marijuana Abuse
• Pregnancy

Intervention

Behavioral:
• LPA+Fitbit Intervention
In-Person LPA+Fitbit Orientation. During an initial, orientation (45 minutes), a study interventionist will provide information regarding the acute and long-term psychological and physical benefits of increasing PA, including prenatally. Telephone PA counseling sessions. A study interventionist will call participants at weeks 2, 4, 6, 8, and 10 of the intervention for a 20-min telephone session. Fitbit activity tracker. With participant permission, a Fitbit account (on Fitbit.com) and study-generated password will be created. In doing so, investigators will have access to the participant activity data throughout the intervention. The Fitbit web-based and mobile apps facilitate goal-setting by allowing participants to easily set goals and change these goals at any point. We will customize each participant account to display daily steps and very active minutes, though they will be encouraged to adjust the display according to their preferences.
• Fitbit Only
In-person Fitbit Orientation. Participants will be given information on the public health guidelines for PA during pregnancy, and as well as how to determine if their PA is moderate-intensity. In addition, interventionists will orient participants to the proper use of the Fitbit tracker and offer tips for self-monitoring step counts with the tracker and on the app. Fitbit Activity Tracker. Participants will be given the same Fitbit as in the LPA condition. Participants will not be given any specific step count goals to achieve during the 12-week intervention. Brief Telephone Check-ins. As with the LPA+Fitbit participants, those in the Fitbit Only condition will receive phone calls on weeks 2, 4, 6, 8, 10. 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.

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 use of coping strategies; includes 14 2-item scales, each ranging from 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