Harnessing the Power of Technology: MOMBA for Postpartum Smoking
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|ClinicalTrials.gov Identifier: NCT02237898|
Recruitment Status : Recruiting
First Posted : September 11, 2014
Last Update Posted : January 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Smoking Cessation||Behavioral: MoMba Live Long app & Sensordrone™ carbon-monoxide sensor Behavioral: Office contingency management Device: Sensordrone™ carbon-monoxide sensor Device: MoMba Live Long Smartphone application||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||SCH: INT: Harnessing the Power of Technology: MOMBA for Postpartum Smoking|
|Study Start Date :||June 2016|
|Estimated Primary Completion Date :||February 2018|
|Estimated Study Completion Date :||August 2018|
Experimental: MoMba Contingency Management
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
MoMba Live Long application & Sensordrone™ carbon-monoxide sensor to deliver contingency management remotely
Device: MoMba Live Long Smartphone application
Active Comparator: Office contingency management
Traditional contingency management with financial incentives delivered in-person in the office for smoking cessation to postpartum women
Behavioral: 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 Sensodrone™ CO sensor.
Device: Sensordrone™ carbon-monoxide sensor
- Acceptability [ Time Frame: 15 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.
- Feasibility [ 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; retention set at 80% for the Momba Smoking group; challenge completion and in-office visit attendance to assess compliance, using mixed-effects regression models for group comparisons. Also, to confirm the sensor, correlation coefficients between the piCO+™ and the Sensordrone™ specific to expired CO measurement and verified through urine cotinine levels.
- Short term abstinence from smoking [ Time Frame: 15 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.
- Long term abstinence from smoking [ 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02237898
|Contact: Ruth M Arnold, PhDemail@example.com|
|Contact: Kimberly Streaterfirstname.lastname@example.org|
|United States, Connecticut|
|Center for Wellbeing of Women and Mothers, 40 Temple Street, Ste 6B, Yale University||Recruiting|
|New Haven, Connecticut, United States, 06510|
|Contact: Ruth M Arnold, PhD 203-764-7629 email@example.com|
|Principal Investigator: Megan V Smith, DrPH|
|Principal Investigator:||Megan V Smith, DrPH||Yale School of Medicine|