Harnessing the Power of Technology: MOMBA for Postpartum Smoking

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 to 50 years
• Women only
• Healthy volunteers accepted
• Adult

Trial locations and contacts

1 site in 1 country.

About this study

Official title: SCH: INT: Harnessing the Power of Technology: MOMBA for Postpartum Smoking

Conditions

Smoking Cessation

Being tested

MoMba Live Long app & Sensordrone™ carbon-monoxide sensor, Office contingency management, Sensordrone™ carbon-monoxide sensor, MoMba Live Long Smartphone application

Keywords

Tobacco cessation

Medical subject headings

Smoking Cessation, Tobacco Use Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• MoMba Live Long app & Sensordrone™ carbon-monoxide sensorBehavioural

  MoMba Live Long application \& Sensordrone™ carbon-monoxide sensor to deliver contingency management remotely

• Office contingency managementBehavioural

  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 sensorDevice

  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 applicationDevice

  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.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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?"

   Measured: 3 and 9 months

2. 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.

   Measured: 15 months

3. 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.

   Measured: 15 months

4. 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).

   Measured: 15 months

5. 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.

   Measured: 15 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted11 Sep 2014 (estimated)
2. Study start10 Feb 2017
3. Primary completion13 May 2019
4. Study completion13 May 2019

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
• Publications (1)Papers the sponsor has linked to this study.
• Other trials for Smoking CessationStudies of the same condition, open and under way.
• More trials run by Yale UniversityThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.