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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01CA195654 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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Through a smartphone platform, financial incentives for smoking abstinence in postpartum women can be delivered remotely, thus minimizing the need for participants to come to the office to receive traditional contingency management.
The specific aims of the proposal are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MoMba Contingency Management | Experimental | Study will provide access to the web-based MoMba Live Long application & Sensodrone™ carbon-monoxide sensor for purposes of researching the acceptability of the smartphone application, operating and functioning of it, and providing remote contingency management for smoking cessation to postpartum women. |
|
| Office contingency management | Active Comparator | Traditional contingency management with financial incentives delivered in-person in the office for smoking cessation to postpartum women |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MoMba Live Long app & Sensordrone™ carbon-monoxide sensor | Behavioral | MoMba Live Long application & Sensordrone™ carbon-monoxide sensor to deliver contingency management remotely |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability | Primary Outcome - Acceptability of the delivery of financial incentives for smoking abstinence in postpartum women through a smartphone platform as compared to traditional, in office contingency management. Acceptability of the smartphone application to low-income, pregnant women defined by the percentage of women who would recommend the site to a friend. Question: "How likely is it that you would recommend MoMba LiveLong to a friend who wants to stop smoking?" | 3 and 9 months |
| Enrollment Rate | Primary Outcome - Feasibility of the delivery of financial incentives for smoking abstinence in postpartum women through a smartphone platform as compared to traditional, in office contingency management. Feasibility: participation rate of > 60% for eligible women between screening and enrollment. Number of women who were eligible from screening that completed an intake. | 15 months |
| Remote Detection | Primary outcome is the correlation coefficient. The correlation coefficient was calculated between the piCO+™ and the Sensordrone™ specific to expired CO measurement and verified through urine cotinine levels. Data for all three instruments was collected during week 1 visits 1-5, 3 month, 9 month and 15 month assessments. | 15 months |
| Retention: Number of Participants Remaining in Study at 12 Weeks | Primary Outcome - Feasibility of the delivery of financial incentives for smoking abstinence in postpartum women through a smartphone platform as compared to traditional, in office contingency management. Feasibility: retention set at 80% for the Momba Smoking group. Number of participants in the intervention group (MoMba Contingency Management) and number of participants in the control group (office contingency management) who remained in the study at the end of contingency management (12 weeks). | 15 months |
| Visit Attendance / Challenge Completion |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Short Term Abstinence From Smoking | Secondary outcome - Short term abstinence from smoking. Immediate smoking prevalence as determined by # of negative breath tests and self-reports; the pilot will also utilize urine tests to measure negative cotinine levels. | 3 months |
| Number of Participants With Long Term Abstinence From Smoking at 9 Month Follow-Up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Megan V Smith, DrPH | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Wellbeing of Women and Mothers, 40 Temple Street, Ste 6B, Yale University | New Haven | Connecticut | 06510 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33231550 | Derived | Valencia S, Callinan L, Shic F, Smith M. Evaluation of the MoMba Live Long Remote Smoking Detection System During and After Pregnancy: Development and Usability Study. JMIR Mhealth Uhealth. 2020 Nov 24;8(11):e18809. doi: 10.2196/18809. |
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| ID | Title | Description |
|---|---|---|
| FG000 | MoMba Contingency Management | MoMba Contingency Management arm accesses the web-based MoMba Live Long application & Sensodrone™ to research the acceptability and functionality of the app and provides remote contingency management for smoking cessation. The Sensordrone™ carbon-monoxide (CO) sensor is a custom breath CO meter built by Sensorcon Inc. (Sensordrone, part No. SDRONEG1) that uses an electrochemical CO gas sensor to measure environmental CO. The Sensordrone is accurate within 10% with a resolution of 1 parts per million (ppm). The MoMba Live Long app provides an interface for the Sensordrone allowing participants to complete a breath test. The app allows for verification of completion of the test through pictures and audio recording. The app also provided a platform for social support during the quitting process. Most breath tests will be completed remotely. |
| FG001 | Office Contingency Management | The Office Contingency Management (control) group will receive financial incentives at an in-person office visit based on expired CO levels obtained through the piCO sensor for smoking cessation to postpartum women. Tests will be verified with urine samples and a breath test on the Sensordrone™. Sensordrone™ carbon-monoxide sensor: A custom breath CO meter built by Sensorcon Inc. (Sensordrone, part No. SDRONEG1) that uses an electrochemical CO gas sensor to measure environmental CO. The Sensordrone is accurate to within 10% with a resolution of 1 parts per million (ppm). The Sensordrone pairs via Bluetooth with the MoMba Live Long application. Control participants will not have access to the MoMba Live Long app. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
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| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MoMba Contingency Management | MoMba Contingency Management arm accesses the web-based MoMba Live Long application & Sensodrone™ to research the acceptability and functionality of the app and provides remote contingency management for smoking cessation. The Sensordrone™ carbon-monoxide (CO) sensor is a custom breath CO meter built by Sensorcon Inc. (Sensordrone, part No. SDRONEG1) that uses an electrochemical CO gas sensor to measure environmental CO. The Sensordrone is accurate within 10% with a resolution of 1 parts per million (ppm). The MoMba Live Long app provides an interface for the Sensordrone allowing participants to complete a breath test. The app allows for verification of completion of the test through pictures and audio recording. The app also provided a platform for social support during the quitting process. Most breath tests will be completed remotely. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Acceptability | Primary Outcome - Acceptability of the delivery of financial incentives for smoking abstinence in postpartum women through a smartphone platform as compared to traditional, in office contingency management. Acceptability of the smartphone application to low-income, pregnant women defined by the percentage of women who would recommend the site to a friend. Question: "How likely is it that you would recommend MoMba LiveLong to a friend who wants to stop smoking?" | This measure was assessed at the 3 and 9 month follow-up assessment. Not all participants who were enrolled completed these assessments. | Posted | Count of Participants | Participants | 3 and 9 months |
|
Data on adverse events were collected during the course of the study (enrollment until the last follow-up at 15 months).
The definition does not differ.
Methods for reporting adverse events: Any serious, unanticipated and related adverse events or unanticipated problems involving risks to subjects or others will be reported in writing within 48 hours to the HIC and any appropriate funding and regulatory agencies. Fellow investigators and study personnel will be informed through regular study meetings and study sponsors will be informed within 5 days of the event becoming known to the principal investigator.
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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 | MoMba Contingency Management | MoMba Contingency Management arm accesses the web-based MoMba Live Long application & Sensodrone™ to research the acceptability and functionality of the app and provides remote contingency management for smoking cessation. The Sensordrone™ carbon-monoxide (CO) sensor is a custom breath CO meter built by Sensorcon Inc. (Sensordrone, part No. SDRONEG1) that uses an electrochemical CO gas sensor to measure environmental CO. The Sensordrone is accurate within 10% with a resolution of 1 parts per million (ppm). The MoMba Live Long app provides an interface for the Sensordrone allowing participants to complete a breath test. The app allows for verification of completion of the test through pictures and audio recording. The app also provided a platform for social support during the quitting process. Most breath tests will be completed remotely. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Megan Smith | Yale School of Medicine | (203) 764-8655 | megan.smith@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 7, 2017 | Mar 10, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D020340 | Tobacco Use Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| Office contingency management | Behavioral | A control group which will receive financial incentives at an in-person office/clinic visit based on expired CO levels obtained through the piCO sensor. |
|
| Sensordrone™ carbon-monoxide sensor | Device | A custom breath CO meter built by Sensorcon Inc. (Sensordrone, part No. SDRONEG1) that uses an electrochemical CO gas sensor to measure environmental CO. The Sensordrone is accurate to within 10% with a resolution of 1 parts per million (ppm). The Sensordrone pairs via Bluetooth with the MoMba Live Long application. |
|
| MoMba Live Long Smartphone application | Device | The MoMba Live Long app provides an interface for the Sensordrone which allows participants to complete a breath test and see results of smoking status. The app verifies the user is correctly taking the tests by recording pictures using the front facing camera as well as recording audio to verify that the participants where exhaling while taking the test. The app also provided a platform for social interaction based on a previous system where app users can interact with each other and provide support during the quitting process. |
|
Primary Outcome - Feasibility of the delivery of financial incentives for smoking abstinence in postpartum women through a smartphone platform as compared to traditional, in office contingency management. Feasibility: challenge completion and in-office visit attendance to assess compliance. MoMba Contingency Management: Number of breath tests completed among participants who remained enrolled at the end of 12 weeks. Office Contingency Management: Number of breath tests (corresponds to office visits) completed among participants who remained enrolled at the end of 12 weeks. |
| 15 months |
Secondary outcome - Long term abstinence from smoking equals 7-day point prevalence determined through # of negative breath tests and self-reports based on the Timeline Follow Back. |
| 9 months |
| Number of Participants With Long Term Abstinence From Smoking at 15 Month Follow-Up | Secondary outcome - Long term abstinence from smoking equals 7-day point prevalence determined through # of negative breath tests and self-reports based on the Timeline Follow Back. | 15 months |
| BG001 | Office Contingency Management | The Office Contingency Management (control) group will receive financial incentives at an in-person office visit based on expired CO levels obtained through the piCO sensor for smoking cessation to postpartum women. Tests will be verified with urine samples and a breath test on the Sensordrone™. Sensordrone™ carbon-monoxide sensor: A custom breath CO meter built by Sensorcon Inc. (Sensordrone, part No. SDRONEG1) that uses an electrochemical CO gas sensor to measure environmental CO. The Sensordrone is accurate to within 10% with a resolution of 1 parts per million (ppm). The Sensordrone pairs via Bluetooth with the MoMba Live Long application. Control participants will not have access to the MoMba Live Long app. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Fagerstrom Test for Nicotine Dependence | Score ranging from 0-10, higher score indicates more nicotine dependence. | Mean | Standard Deviation | units on a scale |
|
| Number Cigarettes Per Day in Past Month | The question asked to the participant was "How many tobacco cigarettes a day have you smoked on average during the last month?" One measure was collected from this question "the average number of cigarettes smoked per day during the last month" per participant. This "average number of cigarettes smoked per day during the last month" was presented in the description. | Median | Inter-Quartile Range | cigarettes / day |
|
| Number of cigarettes smoked in past 7 days | The number of cigarettes smoked in the past 7 days was collected through the self-report timeline follow-back. The average number of cigarettes smoked per day in the past 7 days was calculated as the sum of number of cigarettes smoked per day divided by 7. | Median | Inter-Quartile Range | cigarettes / day |
|
| OG001 | Office Contingency Management | The Office Contingency Management (control) group will receive financial incentives at an in-person office visit based on expired CO levels obtained through the piCO sensor for smoking cessation to postpartum women. Tests will be verified with urine samples and a breath test on the Sensordrone™. Sensordrone™ carbon-monoxide sensor: A custom breath CO meter built by Sensorcon Inc. (Sensordrone, part No. SDRONEG1) that uses an electrochemical CO gas sensor to measure environmental CO. The Sensordrone is accurate to within 10% with a resolution of 1 parts per million (ppm). The Sensordrone pairs via Bluetooth with the MoMba Live Long application. Control participants will not have access to the MoMba Live Long app. |
|
|
| Primary | Enrollment Rate | Primary Outcome - Feasibility of the delivery of financial incentives for smoking abstinence in postpartum women through a smartphone platform as compared to traditional, in office contingency management. Feasibility: participation rate of > 60% for eligible women between screening and enrollment. Number of women who were eligible from screening that completed an intake. | Posted | Count of Participants | Participants | 15 months |
|
|
|
| Primary | Remote Detection | Primary outcome is the correlation coefficient. The correlation coefficient was calculated between the piCO+™ and the Sensordrone™ specific to expired CO measurement and verified through urine cotinine levels. Data for all three instruments was collected during week 1 visits 1-5, 3 month, 9 month and 15 month assessments. | The correlation between the piCO+™, Sensordrone™ and urine cotinine levels are considered and the unit analyzed is a visit, data collected during the first week of office visits and at follow-up assessments. Of participants enrolled, 4 participants who completed a baseline did not attend week 1 and thus didn't contribute any data to this analysis. | Posted | Number | correlation | 15 months | Unique visits | Unique visits |
|
|
|
| Primary | Retention: Number of Participants Remaining in Study at 12 Weeks | Primary Outcome - Feasibility of the delivery of financial incentives for smoking abstinence in postpartum women through a smartphone platform as compared to traditional, in office contingency management. Feasibility: retention set at 80% for the Momba Smoking group. Number of participants in the intervention group (MoMba Contingency Management) and number of participants in the control group (office contingency management) who remained in the study at the end of contingency management (12 weeks). | Posted | Count of Participants | Participants | 15 months |
|
|
|
| Primary | Visit Attendance / Challenge Completion | Primary Outcome - Feasibility of the delivery of financial incentives for smoking abstinence in postpartum women through a smartphone platform as compared to traditional, in office contingency management. Feasibility: challenge completion and in-office visit attendance to assess compliance. MoMba Contingency Management: Number of breath tests completed among participants who remained enrolled at the end of 12 weeks. Office Contingency Management: Number of breath tests (corresponds to office visits) completed among participants who remained enrolled at the end of 12 weeks. | Posted | Median | Inter-Quartile Range | breath tests | 15 months |
|
|
|
|
| Secondary | Number of Participants With Short Term Abstinence From Smoking | Secondary outcome - Short term abstinence from smoking. Immediate smoking prevalence as determined by # of negative breath tests and self-reports; the pilot will also utilize urine tests to measure negative cotinine levels. | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Secondary | Number of Participants With Long Term Abstinence From Smoking at 9 Month Follow-Up | Secondary outcome - Long term abstinence from smoking equals 7-day point prevalence determined through # of negative breath tests and self-reports based on the Timeline Follow Back. | Posted | Count of Participants | Participants | 9 months |
|
|
|
| Secondary | Number of Participants With Long Term Abstinence From Smoking at 15 Month Follow-Up | Secondary outcome - Long term abstinence from smoking equals 7-day point prevalence determined through # of negative breath tests and self-reports based on the Timeline Follow Back. | In the intervention group only 7/8 participants had data for the timeline follow back. | Posted | Count of Participants | Participants | 15 months |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Office Contingency Management | The Office Contingency Management (control) group will receive financial incentives at an in-person office visit based on expired CO levels obtained through the piCO sensor for smoking cessation to postpartum women. Tests will be verified with urine samples and a breath test on the Sensordrone™. Sensordrone™ carbon-monoxide sensor: A custom breath CO meter built by Sensorcon Inc. (Sensordrone, part No. SDRONEG1) that uses an electrochemical CO gas sensor to measure environmental CO. The Sensordrone is accurate to within 10% with a resolution of 1 parts per million (ppm). The Sensordrone pairs via Bluetooth with the MoMba Live Long application. Control participants will not have access to the MoMba Live Long app. | 0 | 14 | 0 | 14 | 0 | 14 |
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| Unlikely |
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| Neutral |
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| Likely |
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| Highly Likely |
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| Pico and Urine |
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| Self-report (no smoking cigs in past 7 days) |
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| Urine test (<50ng) |
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| Last 7 days no smoking (from timeline followback) |
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| Number of negative breath tests using the piCO |
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| Last 7 days no smoking (from timeline followback) |
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