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The overall goal of this pilot study is to develop and preliminarily evaluate an LPA intervention designed to reduce cannabis use during pregnancy.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LPA and Fitbit | Experimental | The 12-week LPA+Fitbit intervention consists of 3 components:
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| Only Fitbit | Active Comparator | The Fitbit Only condition will include 3 components:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LPA+Fitbit Intervention | Behavioral |
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| 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 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 |
| Marijuana Self-Efficacy Questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cynthia Battle, PhD | Butler Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Butler Hospital | Providence | Rhode Island | 02906 | United States |
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Participants will be randomly assigned to either a Fitbit Only Condition, or a Fitbit + A Lifestyle Physical Activity Intervention.
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| Fitbit Only | Behavioral |
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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 |