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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|