Harnessing the Power of Technology: MOMBA for Postpartum Smoking

Phase 1

Completed

• Conditions: Smoking Cessation
• Interventions: Behavioral: MoMba Live Long app & Sensordrone™ carbon-monoxide sensor; Behavioral: Office contingency management; Device: Sensordrone™ carbon-monoxide sensor; Device: MoMba Live Long Smartphone application

• Registration Number: NCT02237898
• Lead Sponsor: Yale University

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.

Study Timeline

• Study First Submitted: 2014-09-09
• Study First Submitted QC: 2014-09-10
• Study First Posted: 2014-09-11
• Study Start: 2017-02-10
• Primary Completion: 2019-05-13
• Study Completion: 2019-05-13
• Results First Submitted: 2020-03-10
• Status Verified: 2020-05
• Results First Submitted QC: 2020-05-08
• Last Update Submitted: 2020-05-08
• Results First Posted: 2020-05-21
• Last Update Posted: 2020-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 26

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).

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MoMba Contingency Management	MoMba Live Long Smartphone application	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.
MoMba Contingency Management	MoMba Live Long app & Sensordrone™ carbon-monoxide sensor	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	Office contingency management	Traditional contingency management with financial incentives delivered in-person in the office for smoking cessation to postpartum women
MoMba Contingency Management	Sensordrone™ carbon-monoxide sensor	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	Sensordrone™ carbon-monoxide sensor	Traditional contingency management with financial incentives delivered in-person in the office for smoking cessation to postpartum women

Primary Outcome Measures

Name	Time	Method
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?"
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.
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.
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).

Secondary Outcome Measures

Name	Time	Method
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.
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 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.

Trial Locations

Locations (1)

Center for Wellbeing of Women and Mothers, 40 Temple Street, Ste 6B, Yale University; 🇺🇸 New Haven, Connecticut, United States