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Lack of Recruitment
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| Name | Class |
|---|---|
| Penn State University | OTHER |
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Our goal is to study self-monitoring of smoking as a means to reduce smoking in pregnant women. Investigators hypothesize that more regular self-monitoring, text messages and feedback as provided by home carbon monoxide monitoring device combined with medical feedback on results will reduce smoking during pregnancy compared to only receiving text message and no self-monitoring by home monitoring device and no feedback by home carbon monoxide monitoring device . The periconceptual period is a life period, where given the immediacy of the fetus and future child, a pregnant woman is willing to try and modify potentially harmful behaviors.
Altering unhealthy behaviors, such as tobacco smoking, that increase cardiovascular disease and cancer risk, has proven remarkably difficult in traditional medical practice settings, and successful medical trials have been costly and labor intensive. This proposal aims to utilize a self-monitoring device, i.e., carbon monoxide monitor to foster smoking cessation among pregnant women who smoke. Investigators hypothesize that women who have access to a self-monitoring device more frequently (i.e., at home) and receive feedback about their carbon monoxide level will have greater reductions in smoking as determined by declining serum cotinine levels over the course of the study compared to women who do not have access to a self-monitoring device and do not receive feedback about their carbon monoxide level, but only receive text messages.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| no CO monitor | Experimental | Not given a piCO+ Smokerlyzer® monitor, will receive daily text messages. |
|
| CO monitor | Experimental | Given a piCO+ Smokerlyzer® monitor, will receive daily text messages, will receive feedback about the relative level of carbon monoxide. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| piCO+ Smokerlyzer® monitor | Device |
| ||
| Text messages |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Outcome of Serum Cotinine Levels | The primary outcome is the difference in serum cotinine levels between the intervention and control groups at the end of the trial. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard S Legro, MD | Penn State College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MS Hershey Medical Center, Penn State College of Medicine | Hershey | Pennsylvania | 17033 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A | no CO monitor |
| FG001 | Arm B | CO monitor |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A | no CO monitor |
| BG001 | Arm B | CO monitor |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Primary Outcome of Serum Cotinine Levels | The primary outcome is the difference in serum cotinine levels between the intervention and control groups at the end of the trial. | Only 1 subject enrolled in this study and she terminated early due to miscarriage at 9 weeks. | Posted | 1 year |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm A (no CO Monitor) | no CO monitor |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| headache | General disorders |
|
The study closed early due to lack of recruitment. Only 1 subject enrolled in the study and she terminated after the baseline visit due to a miscarriage at 9 weeks. Therefore no analysis has been performed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard S. Legro, M.D. | The Milton S. Hershey Medical Center | 717-531-6210 | rsl1@psu.edu |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D015438 | Health Behavior |
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|
| Total |
Total of all reporting groups |
| years |
|
| Gender | Count of Participants | Participants |
|
| Participants |
|
| 0 |
| 1 |
| 1 |
| 1 |
| EG001 | Arm B (CO Monitor) | CO monitor | 0 | 0 | 0 | 0 |
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