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NCT02237898

Harnessing the Power of Technology: MOMBA for Postpartum Smoking

Completed Phase 1 Results posted Last updated 21 May 2020
What this trial tests

Phase 1 trial testing MoMba Live Long app & Sensordrone™ carbon-monoxide sensor in Smoking Cessation in 26 participants. Completed in 13 May 2019.

Timeline
10 February 2017
Primary endpoint
13 May 2019
13 May 2019

Quick facts

Lead sponsorYale University
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment26
Start date10 February 2017
Primary completion13 May 2019
Estimated completion13 May 2019
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Yale University

Who can join

Adults 18 to 50, female only, with Smoking Cessation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Acceptability Primary · 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?"

3 month follow-up assessment
GroupValue95% CI
MoMba Contingency Management0
Office Contingency Management0
MoMba Contingency Management1
Office Contingency Management0
MoMba Contingency Management0
Office Contingency Management0
MoMba Contingency Management0
Office Contingency Management2
9-month follow-up assessment
GroupValue95% CI
MoMba Contingency Management0
Office Contingency Management0
MoMba Contingency Management0
Office Contingency Management0
MoMba Contingency Management1
Office Contingency Management1
MoMba Contingency Management0
Office Contingency Management2
Enrollment Rate Primary · 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.

GroupValue95% CI
Eligible From Screening26
Remote Detection Primary · 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.

Sensordrone and Pico
GroupValue95% CI
MoMba Contingency Management0.93
Office Contingency Management0.87
Sensordrone and Urine
GroupValue95% CI
MoMba Contingency Management0.76
Office Contingency Management0.66
Pico and Urine
GroupValue95% CI
MoMba Contingency Management0.81
Office Contingency Management0.67
Retention: Number of Participants Remaining in Study at 12 Weeks Primary · 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).

GroupValue95% CI
MoMba Contingency Management7
Office Contingency Management2
Visit Attendance / Challenge Completion Primary · 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.

GroupValue95% CI
MoMba Contingency Management1615 – 22
Office Contingency Management21.520 – 23
Number of Participants With Short Term Abstinence From Smoking Secondary · 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.

Number of negative breath tests using Sensordrone
GroupValue95% CI
MoMba Contingency Management2
Office Contingency Management2
Number of negative breath tests using piCO
GroupValue95% CI
MoMba Contingency Management3
Office Contingency Management2
Self-report (no smoking cigs in past 7 days)
GroupValue95% CI
MoMba Contingency Management3
Office Contingency Management1
Urine test (<50ng)
GroupValue95% CI
MoMba Contingency Management3
Office Contingency Management1
Number of Participants With Long Term Abstinence From Smoking at 9 Month Follow-Up Secondary · 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.

Number of negative breath tests using Sensordrone
GroupValue95% CI
MoMba Contingency Management2
Office Contingency Management2
Number of negative breath tests using the piCO
GroupValue95% CI
MoMba Contingency Management3
Office Contingency Management3
Last 7 days no smoking (from timeline followback)
GroupValue95% CI
MoMba Contingency Management1
Office Contingency Management0
Number of Participants With Long Term Abstinence From Smoking at 15 Month Follow-Up Secondary · 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.

Number of negative breath tests using Sensordrone
GroupValue95% CI
MoMba Contingency Management3
Office Contingency Management4
Number of negative breath tests using the piCO
GroupValue95% CI
MoMba Contingency Management3
Office Contingency Management4
Last 7 days no smoking (from timeline followback)
GroupValue95% CI
MoMba Contingency Management1
Office Contingency Management0

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Mobile phone-based interventions for smoking cessation.
    Whittaker R, McRobbie H, Bullen C, Rodgers A, et al · · 2016 · cited 372× · PMID 27060875 · DOI 10.1002/14651858.cd006611.pub4
  2. Mobile phone text messaging and app-based interventions for smoking cessation.
    Whittaker R, McRobbie H, Bullen C, Rodgers A, et al · · 2019 · cited 278× · PMID 31638271 · DOI 10.1002/14651858.cd006611.pub5
  3. Incentives for smoking cessation.
    Notley C, Gentry S, Livingstone-Banks J, Bauld L, et al · · 2019 · cited 166× · PMID 31313293 · DOI 10.1002/14651858.cd004307.pub6
  4. Evaluation of the MoMba Live Long Remote Smoking Detection System During and After Pregnancy: Development and Usability Study.
    Valencia S, Callinan L, Shic F, Smith M. · · 2020 · cited 5× · PMID 33231550 · DOI 10.2196/18809

Verify or expand the search:

Other recruiting trials for Smoking Cessation

Currently open trials in the same condition.

Other Yale University trials

Trials by the same sponsor.

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing