Cannabis, Pregnancy
Conditions
Brief 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.
Detailed 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.
Interventions
BEHAVIORALLPA + 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.
Sponsors
Butler Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| International Physical Activity Questionnaire (IPAQ) Walked 10+ Continuous Min/Day | Baseline to 12-week endpoint | Number who reported walking 4 or more days/week for 10 or more continuous minutes per day |
| Number of Participants Using Cannabis | from week 6 to the end of the intervention at week 12 | Number of participants using cannabis at week 12, assessed via the Timeline Follow Back |
| Steps/Day | Baseline to 12-week endpoint | objectively-measured via wearable device |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Edinburgh Postnatal Depression Screen | past week, assessed at week 12 (end of intervention) | Self-report measure of depression severity; scores range from 0-30, with higher scores indicating more severe depression |
| Generalized Anxiety Disorder -7 | past 2 weeks, assessed at week 12 (end of intervention) | Self-report measure of anxiety severity; scores range from 0-21, with higher scoring indicating more severe anxiety |
| Client Satisfaction Questionnaire (CSQ-8) | Week 12 End of Treatment (EOT) | The Client Satisfaction Questionnaire is an 8 item survey of participant satisfaction. Scores range from 8-32; higher scores indicate higher satisfaction. |
Countries
United States
Participant flow
Recruitment details
This study used wide-scale community recruitment to reach a number of sites serving perinatal women, including OB/GYN, primary care and behavioral health settings, as well as community based advertising online (e.g. hospital website, social media such as Facebook) and in-person community fliers. All potential participants were screened by phone.
Pre-assignment details
Because this was an Open Trial, all eligible participants were assigned to the lifestyle physical activity intervention. Please note that this study was funded as part of an NIH R34 award that involved 2 different studies. The current project reported here (NCTNCT05528380) was an open pilot trial; in addition, there was a second study funded by the R34, which was a pilot randomized controlled trial (RCT). The pilot RCT study was designated a separate NCT entry (NCT06239701).
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 29.88 years STANDARD_DEVIATION 6.28 |
| Edinburgh Perinatal Depression Scale (EPDS) | 12.91 scores on a scale STANDARD_DEVIATION 3.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| General Anxiety Disorder -7 (GAD-7) | 8.27 scores on a scale STANDARD_DEVIATION 4.54 |
| International Physical Activity Questionnaire (IPAQ) walked 10+ continuous min/day | 6 Participants |
| Number of participants using cannabis at baseline | 10 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 0 Participants |
| Step Counts: average steps per day | 5738 steps/day STANDARD_DEVIATION 1554 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 16 |
| other Total, other adverse events | 2 / 16 |
| serious Total, serious adverse events | 0 / 16 |
Outcome results
None listed