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Pilot Trial of Using SmokeBeat to Monitor and Increase Smoking Abstinence in Pregnant Women

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ClinicalTrials.gov Identifier: NCT03209557
Recruitment Status : Completed
First Posted : July 6, 2017
Last Update Posted : May 9, 2019
Sponsor:
Information provided by (Responsible Party):
Alison Buttenheim, University of Pennsylvania

Brief Summary:
Investigators will assess the feasibility of implementing a randomized control trial of a behavioral intervention that uses smartwatch technology to monitor smoking behavior with texts aimed at reducing smoking in pregnant women who smoke. Investigators will compare the cessation rate of pregnant women who receive usual care through programs aimed at reducing smoking with pregnant women who receive usual care and are using the SmokeBeat app with a smartwatch.

Condition or disease Intervention/treatment Phase
Tobacco Use Cessation Pregnancy Related Other: SmartWatch SmokeBeat Application Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Trial Testing Feasibility and Effectiveness of Using SmokeBeat to Monitor and Increase Smoking Abstinence in Pregnant Women
Actual Study Start Date : July 5, 2017
Actual Primary Completion Date : April 30, 2019
Actual Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
No Intervention: Control
25 pregnant women will be enrolled and provided with usual care through Healthy Beginnings or NFP but will not receive a smartwatch or the active intervention. Smoking behavior will be measured by self-report and sample testing for the duration of the trial. Self-reported smoking status will be collected weekly. Sample testing will occur weekly and will be identical to the intervention group. They will be compensated for sample collection and survey completion.
Experimental: SmokeBeat Intervention

25 pregnant women will be enrolled and provided with a smartwatch. The smartwatch SmokeBeat application will be active. Smoking behavior will be measured by the smartwatch for the duration of the trial. Self-reported smoking status will be collected weekly. Sample testing will occur weekly.

A second phase of the trial was initiated to evaluate a new watch. The smoking habits of participants who are receiving financial incentives to wear the watch are being compared to participants who are being given financial incentives for every day they go without smoking.

A third phase of the trial was initiated to evaluate efficacy of larger financial incentives. All participants are incentivized to wear the watch, with the experimental arm also incentivized to abstain from smoking.

Other: SmartWatch SmokeBeat Application
The SmokeBeat app is a digital health app that allows for the user to monitor their smoking behavior in real time, set smoking cessation goals, and allows investigators, doctors and others using the app with participants to send messages directly related to smoking behavior. The SmokeBeat app, developed by Somatix Inc., will collects time-stamped on hand movements associated with smoking behavior. Participants will receive notifications on their phone and smartwatch when a smoking bout has been detected. In addition this app will deliver daily text messages aimed at improving quit rates among participants. We will be able to create the types of messaging we want to send and to modify when these messages will be sent to all participants. http://somatixinc.com/smokebeat/




Primary Outcome Measures :
  1. Smoking cessation rate biochemical verification [ Time Frame: 12 weeks ]
    Quit rates in control vs. intervention group as determined by weekly cotinine testing.

  2. Smoking cessation rate smartwatch [ Time Frame: 12 weeks ]
    Quit rates in control vs. intervention group as measured by the smartwatch.


Secondary Outcome Measures :
  1. Desire to quit [ Time Frame: 12 weeks ]
    We will compare the self-reported desire to quit before and after the study and compare across groups.

  2. Usability of the smartwatch and application [ Time Frame: 12 weeks ]
    We will measure through self-report the usability participants experience while using the SmokeBeat application and smartwatch.

  3. Usability of the smartwatch and application [ Time Frame: 12 weeks ]
    We will measure through qualitative interviews the usability participants experience while using the SmokeBeat application and smartwatch.

  4. Likability of the smartwatch and application [ Time Frame: 12 weeks ]
    We will measure through self-report the likability participants experience while using the SmokeBeat application and smartwatch.

  5. Likability of the smartwatch and application [ Time Frame: 12 weeks ]
    We will measure through qualitative interviews the likability participants experience while using the SmokeBeat application and smartwatch.

  6. Number of cigarettes smoked self-report [ Time Frame: 12 weeks ]
    Number of cigarettes smoked in control vs. intervention group as measured by self-report.

  7. Number of cigarettes smoked measured by smartwatch [ Time Frame: 12 weeks ]
    Number of cigarettes smoked in control vs. intervention group as measured by the smartwatch.

  8. Smoking cessation rate self-report [ Time Frame: 12 weeks ]
    Quit rates in control vs. intervention group as measured by self-report.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Based on whether someone is currently pregnant or within 3 weeks post-partum
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant or within 3 weeks postpartum
  • Self-reported smoking
  • Part of the Nurse Family Partnership or Healthy Beginnings
  • Uses an Android smart phone

Exclusion Criteria:

  • Does not speak English
  • Not interested in wearing a smart watch for 12 weeks

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): NCT03209557


Locations
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United States, Pennsylvania
Lancaster General Hospital
Lancaster, Pennsylvania, United States, 17602
Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: Alison Buttenheim, PhD, MBA University of Pennsylvania

Publications of Results:
Centers for Disease Control and Prevention (CDC). The Health Consequences of Smoking: A Report of the Surgeon General. Atlanta: U.S. Department of Health and Human Services; 2004. U.S. Department of Health and Human Services. The Health Consequences of Smoking: A Report of the Surgeon General. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, 2004
Pregnancy Risk Assessment Monitoring System (PRAMS) and Smoking, Data from 2000-2011. http://www.cdc.gov/prams/pramstat/index.html

Other Publications:
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Responsible Party: Alison Buttenheim, Assistant Professor of Nursing, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03209557     History of Changes
Other Study ID Numbers: 827096
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Each participant will have a unique identifier to protect their confidentiality. Only pre-specified research coordinators will have access to identifiable participant information for contacting participants for follow-up.

Only authorized personnel will have access to the data which will be maintained on encrypted hard-drives and destroyed after 7 years.


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alison Buttenheim, University of Pennsylvania:
Mobile Technology
Sociobehavioral