Harnessing the Power of Technology: MOMBA for Postpartum Smoking

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02237898
• Other study ID #: 1407014326
• Secondary ID: 5R01CA195654
• Status: Completed
• Phase: Phase 1
• Start date: February 10, 2017
• Est. completion date: May 13, 2019

Study information

• Verified date: May 2020
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: May 13, 2019
• Est. primary completion date: May 13, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Behavioral:
• MoMba Live Long app & Sensordrone™ carbon-monoxide sensor
MoMba Live Long application & Sensordrone™ carbon-monoxide sensor to deliver contingency management remotely
• Office 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.

Device:
• 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.
• MoMba 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.

Locations

Country	Name	City	State
United States	Center for Wellbeing of Women and Mothers, 40 Temple Street, Ste 6B, Yale University	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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?"	3 and 9 months
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.	15 months
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.	15 months
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).	15 months
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.	15 months
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.	3 months
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.	9 months
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.	15 months