Trial Outcomes & Findings for Harnessing the Power of Technology: MOMBA for Postpartum Smoking (NCT NCT02237898)

NCT ID: NCT02237898

Last Updated: 2020-05-21

Results Overview

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?"

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

26 participants

Primary outcome timeframe

3 and 9 months

Results posted on

2020-05-21

Participant Flow

Participant milestones

Participant milestones
Measure
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.
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.
Overall Study
STARTED
12
14
Overall Study
Completed 12 Weeks of CM
7
2
Overall Study
Completed 3 Month Follow-up
6
6
Overall Study
Completed 9 Month Follow-up
6
7
Overall Study
Completed 15 Month Follow-up
8
8
Overall Study
COMPLETED
5
2
Overall Study
NOT COMPLETED
7
12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Harnessing the Power of Technology: MOMBA for Postpartum Smoking

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
MoMba Contingency Management
n=12 Participants
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.
Office Contingency Management
n=14 Participants
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.
Total
n=26 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
12 Participants
n=5 Participants
14 Participants
n=7 Participants
26 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Continuous
31.08 years
STANDARD_DEVIATION 6.17 • n=5 Participants
28.93 years
STANDARD_DEVIATION 5.54 • n=7 Participants
29.92 years
STANDARD_DEVIATION 5.82 • n=5 Participants
Sex: Female, Male
Female
12 Participants
n=5 Participants
14 Participants
n=7 Participants
26 Participants
n=5 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race/Ethnicity, Customized
Race / Ethnicity · White, non-Hispanic
4 Participants
n=5 Participants
3 Participants
n=7 Participants
7 Participants
n=5 Participants
Race/Ethnicity, Customized
Race / Ethnicity · Black or African American, Non-Hispanic
4 Participants
n=5 Participants
8 Participants
n=7 Participants
12 Participants
n=5 Participants
Race/Ethnicity, Customized
Race / Ethnicity · White, Hispanic
1 Participants
n=5 Participants
1 Participants
n=7 Participants
2 Participants
n=5 Participants
Race/Ethnicity, Customized
Race / Ethnicity · Black or African American, Hispanic
1 Participants
n=5 Participants
2 Participants
n=7 Participants
3 Participants
n=5 Participants
Race/Ethnicity, Customized
Race / Ethnicity · Other
2 Participants
n=5 Participants
0 Participants
n=7 Participants
2 Participants
n=5 Participants
Fagerstrom Test for Nicotine Dependence
3.58 units on a scale
STANDARD_DEVIATION 2.02 • n=5 Participants
4.07 units on a scale
STANDARD_DEVIATION 2.06 • n=7 Participants
3.85 units on a scale
STANDARD_DEVIATION 2.01 • n=5 Participants
Number Cigarettes Per Day in Past Month
7 cigarettes / day
n=5 Participants
7 cigarettes / day
n=7 Participants
7 cigarettes / day
n=5 Participants
Number of cigarettes smoked in past 7 days
6 cigarettes / day
n=5 Participants
5.5 cigarettes / day
n=7 Participants
6 cigarettes / day
n=5 Participants

PRIMARY outcome

Timeframe: 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.

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?"

Outcome measures

Outcome measures
Measure
MoMba Contingency Management
n=6 Participants
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.
Office Contingency Management
n=7 Participants
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.
Acceptability
3 month follow-up assessment · Highly Unlikely
0 Participants
0 Participants
Acceptability
3 month follow-up assessment · Unlikely
1 Participants
0 Participants
Acceptability
3 month follow-up assessment · Neutral
0 Participants
0 Participants
Acceptability
3 month follow-up assessment · Likely
0 Participants
2 Participants
Acceptability
3 month follow-up assessment · Highly Likely
5 Participants
4 Participants
Acceptability
9-month follow-up assessment · Highly Unlikely
0 Participants
0 Participants
Acceptability
9-month follow-up assessment · Unlikely
0 Participants
0 Participants
Acceptability
9-month follow-up assessment · Neutral
1 Participants
1 Participants
Acceptability
9-month follow-up assessment · Likely
0 Participants
2 Participants
Acceptability
9-month follow-up assessment · Highly Likely
5 Participants
4 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
MoMba Contingency Management
n=43 Participants
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.
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.
Enrollment Rate
26 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
MoMba Contingency Management
n=56 Unique visits
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.
Office Contingency Management
n=53 Unique visits
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.
Remote Detection
Sensordrone and Pico
0.93 correlation
0.87 correlation
Remote Detection
Sensordrone and Urine
0.76 correlation
0.66 correlation
Remote Detection
Pico and Urine
0.81 correlation
0.67 correlation

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure
MoMba Contingency Management
n=12 Participants
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.
Office Contingency Management
n=14 Participants
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.
Retention: Number of Participants Remaining in Study at 12 Weeks
7 Participants
2 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
MoMba Contingency Management
n=7 Participants
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.
Office Contingency Management
n=2 Participants
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.
Visit Attendance / Challenge Completion
16 breath tests
Interval 15.0 to 22.0
21.5 breath tests
Interval 20.0 to 23.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
MoMba Contingency Management
n=6 Participants
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.
Office Contingency Management
n=6 Participants
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.
Number of Participants With Short Term Abstinence From Smoking
Number of negative breath tests using Sensordrone
2 Participants
2 Participants
Number of Participants With Short Term Abstinence From Smoking
Number of negative breath tests using piCO
3 Participants
2 Participants
Number of Participants With Short Term Abstinence From Smoking
Self-report (no smoking cigs in past 7 days)
3 Participants
1 Participants
Number of Participants With Short Term Abstinence From Smoking
Urine test (<50ng)
3 Participants
1 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
MoMba Contingency Management
n=6 Participants
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.
Office Contingency Management
n=7 Participants
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.
Number of Participants With Long Term Abstinence From Smoking at 9 Month Follow-Up
Number of negative breath tests using Sensordrone
2 Participants
2 Participants
Number of Participants With Long Term Abstinence From Smoking at 9 Month Follow-Up
Number of negative breath tests using the piCO
3 Participants
3 Participants
Number of Participants With Long Term Abstinence From Smoking at 9 Month Follow-Up
Last 7 days no smoking (from timeline followback)
1 Participants
0 Participants

SECONDARY outcome

Timeframe: 15 months

Population: In the intervention group only 7/8 participants had data for the timeline follow back.

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.

Outcome measures

Outcome measures
Measure
MoMba Contingency Management
n=8 Participants
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.
Office Contingency Management
n=8 Participants
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.
Number of Participants With Long Term Abstinence From Smoking at 15 Month Follow-Up
Number of negative breath tests using Sensordrone
3 Participants
4 Participants
Number of Participants With Long Term Abstinence From Smoking at 15 Month Follow-Up
Number of negative breath tests using the piCO
3 Participants
4 Participants
Number of Participants With Long Term Abstinence From Smoking at 15 Month Follow-Up
Last 7 days no smoking (from timeline followback)
1 Participants
0 Participants

Adverse Events

MoMba Contingency Management

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Office Contingency Management

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Megan Smith

Yale School of Medicine

Phone: (203) 764-8655

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place