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Trial record 48 of 137 for:    carbon monoxide

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
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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.

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

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women who are over the age of 18
  • Speak English
  • 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

Information from the National Library of Medicine

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


Contacts
Contact: Ruth M Arnold, PhD 203-764-7629 ruth.arnold@yale.edu
Contact: Kimberly Streater 203-764-7629 kimberly.streater@yale.edu

Locations
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    ruth.arnold@yale.edu   
Principal Investigator: Megan V Smith, DrPH         
Sponsors and Collaborators
Yale University
National Cancer Institute (NCI)
Investigators
Principal Investigator: Megan V Smith, DrPH Yale School of Medicine

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02237898     History of Changes
Other Study ID Numbers: 1407014326
5R01CA195654 ( U.S. NIH Grant/Contract )
First Posted: September 11, 2014    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Yale University:
Tobacco cessation

Additional relevant MeSH terms:
Carbon Monoxide
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Gasotransmitters
Neurotransmitter Agents
Physiological Effects of Drugs