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Completed

NCT Number: NCT02237898

Harnessing the Power of Technology: MOMBA for Postpartum Smoking

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.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior Tobacco Use Cessation

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Center for Wellbeing of Women and Mothers, 40 Temple Street, Ste 6B, Yale University

New Haven, Connecticut, 06510, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MoMba Live Long app & Sensordrone™ carbon-monoxide sensor

Behavioral

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

Office contingency management

Behavioral

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 sensor

Device

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

Device

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.

Primary outcomes

  1. Acceptability

    Time frame: 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?"

  2. Enrollment Rate

    Time frame: 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.

  3. Remote Detection

    Time frame: 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.

  4. Retention: Number of Participants Remaining in Study at 12 Weeks

    Time frame: 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).

  5. Visit Attendance / Challenge Completion

    Time frame: 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.

Secondary outcomes

  1. Number of Participants With Short Term Abstinence From Smoking

    Time frame: 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.

  2. Number of Participants With Long Term Abstinence From Smoking at 9 Month Follow-Up

    Time frame: 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.

  3. Number of Participants With Long Term Abstinence From Smoking at 15 Month Follow-Up

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 11, 2014
Registry last updated
May 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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