Harnessing the Power of Technology: MOMBA for Postpartum Smoking

Study Overview
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Brief Summary
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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.

Detailed Description
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The specific aims of the proposal are: 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. 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. 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.

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

Conditions
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Smoking Cessation

Intervention / Treatment
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* Behavioral: MoMba Live Long app & Sensordrone™ carbon-monoxide sensor
* Behavioral: Office contingency management
* Device: Sensordrone™ carbon-monoxide sensor
* Device: MoMba Live Long Smartphone application


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MoMba Contingency Management<br>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. | Behavioral: MoMba Live Long app & Sensordrone™ carbon-monoxide sensor<br>* MoMba Live Long application & Sensordrone™ carbon-monoxide sensor to deliver contingency management remotely<br>Device: Sensordrone™ carbon-monoxide sensor<br>* 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.<br>Device: MoMba Live Long Smartphone application<br>* 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.<br>|
| Active Comparator: Office contingency management<br>Traditional contingency management with financial incentives delivered in-person in the office for smoking cessation to postpartum women | Behavioral: Office contingency management<br>* 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.<br>Device: Sensordrone™ carbon-monoxide sensor<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 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 Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tobacco cessation