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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | In the Open Trial all participants received 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LPA + Fitbit Intervention | Behavioral | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Butler Hospital | Providence | Rhode Island | 02906 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 22, 2026 |
| ID | Term |
|---|---|
| D002189 | Marijuana Abuse |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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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 |
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 |