Smoking Cessation
Conditions
Keywords
Tobacco cessation
Brief summary
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.
Detailed description
The specific aims of the proposal are: 1. To develop through a 15-month pilot study, a novel smartphone-based system, Momba Smoking, that can be used in further relapse prevention trials for postpartum smokers. 2. To determine, through a pilot randomized controlled trial, the potential feasibility, acceptability, and methodological parameters that are necessary to design a subsequent, appropriately powered, randomized controlled trial of the Momba Smoking smartphone-based system. 3. To advance discovery and understanding on the use of technology to translate smoking cessation interventions from clinical to community settings through the training of the next generation of scientists.
Interventions
BEHAVIORALMoMba Live Long app & Sensordrone™ carbon-monoxide sensor
MoMba Live Long application & Sensordrone™ carbon-monoxide sensor to deliver contingency management remotely
BEHAVIORALOffice contingency management
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.
DEVICESensordrone™ 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.
DEVICEMoMba Live Long Smartphone application
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.
Sponsors
National Cancer Institute (NCI)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Women who are over the age of 18 * Speak English * Second or third trimester of pregnancy * Smoking in the third trimester of pregnancy * No complicating general medical or psychiatric conditions (including marijuana use).
Exclusion criteria
* Receiving other smoking cessation medication * Planning to move out of New Haven in the next 15 months * Actively suicidal, psychotic or unable to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visit Attendance / Challenge Completion | 15 months | 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. |
| Enrollment Rate | 15 months | 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. |
| Remote Detection | 15 months | 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. |
| Retention: Number of Participants Remaining in Study at 12 Weeks | 15 months | 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). |
| Acceptability | 3 and 9 months | 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? |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Long Term Abstinence From Smoking at 9 Month Follow-Up | 9 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. |
| Number of Participants With Long Term Abstinence From Smoking at 15 Month Follow-Up | 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. |
| Number of Participants With Short Term Abstinence From Smoking | 3 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 12 |
| 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. | 14 |
| Total | 26 |
Baseline characteristics
| Characteristic | MoMba Contingency Management | Office Contingency Management | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 14 Participants | 26 Participants |
| Age, Continuous | 31.08 years STANDARD_DEVIATION 6.17 | 28.93 years STANDARD_DEVIATION 5.54 | 29.92 years STANDARD_DEVIATION 5.82 |
| Fagerstrom Test for Nicotine Dependence | 3.58 units on a scale STANDARD_DEVIATION 2.02 | 4.07 units on a scale STANDARD_DEVIATION 2.06 | 3.85 units on a scale STANDARD_DEVIATION 2.01 |
| Number Cigarettes Per Day in Past Month | 7 cigarettes / day | 7 cigarettes / day | 7 cigarettes / day |
| Number of cigarettes smoked in past 7 days | 6 cigarettes / day | 5.5 cigarettes / day | 6 cigarettes / day |
| Race/Ethnicity, Customized Race / Ethnicity Black or African American, Hispanic | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Race / Ethnicity Black or African American, Non-Hispanic | 4 Participants | 8 Participants | 12 Participants |
| Race/Ethnicity, Customized Race / Ethnicity Other | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Race / Ethnicity White, Hispanic | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Race / Ethnicity White, non-Hispanic | 4 Participants | 3 Participants | 7 Participants |
| Sex: Female, Male Female | 12 Participants | 14 Participants | 26 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 14 |
| other Total, other adverse events | 0 / 12 | 0 / 14 |
| serious Total, serious adverse events | 0 / 12 | 0 / 14 |
Outcome results
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?
Time frame: 3 and 9 months
Population: This measure was assessed at the 3 and 9 month follow-up assessment. Not all participants who were enrolled completed these assessments.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| MoMba Contingency Management | Acceptability | 9-month follow-up assessment | Likely | 0 Participants |
| MoMba Contingency Management | Acceptability | 3 month follow-up assessment | Highly Unlikely | 0 Participants |
| MoMba Contingency Management | Acceptability | 3 month follow-up assessment | Unlikely | 1 Participants |
| MoMba Contingency Management | Acceptability | 3 month follow-up assessment | Neutral | 0 Participants |
| MoMba Contingency Management | Acceptability | 3 month follow-up assessment | Likely | 0 Participants |
| MoMba Contingency Management | Acceptability | 3 month follow-up assessment | Highly Likely | 5 Participants |
| MoMba Contingency Management | Acceptability | 9-month follow-up assessment | Highly Unlikely | 0 Participants |
| MoMba Contingency Management | Acceptability | 9-month follow-up assessment | Unlikely | 0 Participants |
| MoMba Contingency Management | Acceptability | 9-month follow-up assessment | Neutral | 1 Participants |
| MoMba Contingency Management | Acceptability | 9-month follow-up assessment | Highly Likely | 5 Participants |
| Office Contingency Management | Acceptability | 9-month follow-up assessment | Unlikely | 0 Participants |
| Office Contingency Management | Acceptability | 9-month follow-up assessment | Likely | 2 Participants |
| Office Contingency Management | Acceptability | 3 month follow-up assessment | Highly Likely | 4 Participants |
| Office Contingency Management | Acceptability | 3 month follow-up assessment | Highly Unlikely | 0 Participants |
| Office Contingency Management | Acceptability | 9-month follow-up assessment | Highly Likely | 4 Participants |
| Office Contingency Management | Acceptability | 3 month follow-up assessment | Unlikely | 0 Participants |
| Office Contingency Management | Acceptability | 9-month follow-up assessment | Highly Unlikely | 0 Participants |
| Office Contingency Management | Acceptability | 3 month follow-up assessment | Neutral | 0 Participants |
| Office Contingency Management | Acceptability | 9-month follow-up assessment | Neutral | 1 Participants |
| Office Contingency Management | Acceptability | 3 month follow-up assessment | Likely | 2 Participants |
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.
Time frame: 15 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MoMba Contingency Management | Enrollment Rate | 26 Participants |
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.
Time frame: 15 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MoMba Contingency Management | Remote Detection | Sensordrone and Pico | 0.93 correlation |
| MoMba Contingency Management | Remote Detection | Sensordrone and Urine | 0.76 correlation |
| MoMba Contingency Management | Remote Detection | Pico and Urine | 0.81 correlation |
| Office Contingency Management | Remote Detection | Sensordrone and Pico | 0.87 correlation |
| Office Contingency Management | Remote Detection | Sensordrone and Urine | 0.66 correlation |
| Office Contingency Management | Remote Detection | Pico and Urine | 0.67 correlation |
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).
Time frame: 15 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MoMba Contingency Management | Retention: Number of Participants Remaining in Study at 12 Weeks | 7 Participants |
| Office Contingency Management | Retention: Number of Participants Remaining in Study at 12 Weeks | 2 Participants |
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.
Time frame: 15 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MoMba Contingency Management | Visit Attendance / Challenge Completion | 16 breath tests |
| Office Contingency Management | Visit Attendance / Challenge Completion | 21.5 breath tests |
p-value: 0.3Wilcoxon (Mann-Whitney)
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.
Time frame: 15 months
Population: In the intervention group only 7/8 participants had data for the timeline follow back.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MoMba Contingency Management | Number of Participants With Long Term Abstinence From Smoking at 15 Month Follow-Up | Number of negative breath tests using Sensordrone | 3 Participants |
| MoMba Contingency Management | Number of Participants With Long Term Abstinence From Smoking at 15 Month Follow-Up | Number of negative breath tests using the piCO | 3 Participants |
| MoMba Contingency Management | Number of Participants With Long Term Abstinence From Smoking at 15 Month Follow-Up | Last 7 days no smoking (from timeline followback) | 1 Participants |
| Office Contingency Management | Number of Participants With Long Term Abstinence From Smoking at 15 Month Follow-Up | Number of negative breath tests using Sensordrone | 4 Participants |
| Office Contingency Management | Number of Participants With Long Term Abstinence From Smoking at 15 Month Follow-Up | Number of negative breath tests using the piCO | 4 Participants |
| Office Contingency Management | Number of Participants With Long Term Abstinence From Smoking at 15 Month Follow-Up | Last 7 days no smoking (from timeline followback) | 0 Participants |
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.
Time frame: 9 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MoMba Contingency Management | Number of Participants With Long Term Abstinence From Smoking at 9 Month Follow-Up | Number of negative breath tests using Sensordrone | 2 Participants |
| MoMba Contingency Management | Number of Participants With Long Term Abstinence From Smoking at 9 Month Follow-Up | Number of negative breath tests using the piCO | 3 Participants |
| MoMba Contingency Management | Number of Participants With Long Term Abstinence From Smoking at 9 Month Follow-Up | Last 7 days no smoking (from timeline followback) | 1 Participants |
| Office Contingency Management | Number of Participants With Long Term Abstinence From Smoking at 9 Month Follow-Up | Number of negative breath tests using Sensordrone | 2 Participants |
| Office Contingency Management | Number of Participants With Long Term Abstinence From Smoking at 9 Month Follow-Up | Number of negative breath tests using the piCO | 3 Participants |
| Office Contingency Management | Number of Participants With Long Term Abstinence From Smoking at 9 Month Follow-Up | Last 7 days no smoking (from timeline followback) | 0 Participants |
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.
Time frame: 3 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MoMba Contingency Management | Number of Participants With Short Term Abstinence From Smoking | Number of negative breath tests using Sensordrone | 2 Participants |
| MoMba Contingency Management | Number of Participants With Short Term Abstinence From Smoking | Number of negative breath tests using piCO | 3 Participants |
| MoMba Contingency Management | Number of Participants With Short Term Abstinence From Smoking | Self-report (no smoking cigs in past 7 days) | 3 Participants |
| MoMba Contingency Management | Number of Participants With Short Term Abstinence From Smoking | Urine test (<50ng) | 3 Participants |
| Office Contingency Management | Number of Participants With Short Term Abstinence From Smoking | Urine test (<50ng) | 1 Participants |
| Office Contingency Management | Number of Participants With Short Term Abstinence From Smoking | Number of negative breath tests using Sensordrone | 2 Participants |
| Office Contingency Management | Number of Participants With Short Term Abstinence From Smoking | Self-report (no smoking cigs in past 7 days) | 1 Participants |
| Office Contingency Management | Number of Participants With Short Term Abstinence From Smoking | Number of negative breath tests using piCO | 2 Participants |