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

NCT03209557 | Completed

• 1 other identifier: 827096
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Use Cessation; Pregnancy Related

Keywords

Mobile Technology; Sociobehavioral

Outcome Measures

Primary Outcomes (2)

• Smoking cessation rate biochemical verification

  Quit rates in control vs. intervention group as determined by weekly cotinine testing.

  12 weeks

• Smoking cessation rate smartwatch

  Quit rates in control vs. intervention group as measured by the smartwatch.

  12 weeks

Secondary Outcomes (8)

• Desire to quit

  12 weeks

• Usability of the smartwatch and application

  12 weeks

• Usability of the smartwatch and application

  12 weeks

• Likability of the smartwatch and application

  12 weeks

• Likability of the smartwatch and application

  12 weeks

Study Arms (2)

Control

NO INTERVENTION

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.

SmokeBeat Intervention

EXPERIMENTAL

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

Interventions

SmartWatch SmokeBeat Application OTHER

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/

SmokeBeat Intervention

Eligibility Criteria

• Gender Eligibility Details: Based on whether someone is currently pregnant or within 3 weeks post-partum
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Lancaster General Hospital

Lancaster, Pennsylvania, 17602, United States

Location

Related Publications (12)

• McCallum DM, Fosson GH, Pisu M. Making the case for medicaid funding of smoking cessation treatment programs: an application to state-level health care savings. J Health Care Poor Underserved. 2014 Nov;25(4):1922-40. doi: 10.1353/hpu.2014.0171.

  PMID: 25418250 BACKGROUND

• 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

  RESULT

• Salihu HM, Aliyu MH, Pierre-Louis BJ, Alexander GR. Levels of excess infant deaths attributable to maternal smoking during pregnancy in the United States. Matern Child Health J. 2003 Dec;7(4):219-27. doi: 10.1023/a:1027319517405.

  PMID: 14682499 RESULT

• Pregnancy Risk Assessment Monitoring System (PRAMS) and Smoking, Data from 2000-2011. http://www.cdc.gov/prams/pramstat/index.html

  RESULT

• Adams EK, Melvin CL, Raskind-Hood C, Joski PJ, Galactionova E. Infant delivery costs related to maternal smoking: an update. Nicotine Tob Res. 2011 Aug;13(8):627-37. doi: 10.1093/ntr/ntr042. Epub 2011 Jul 20.

  PMID: 21778148 RESULT

• Kornhauser M, Schneiderman R. How plans can improve outcomes and cut costs for preterm infant care. Manag Care. 2010 Jan;19(1):28-30. No abstract available.

  PMID: 20131638 RESULT

• Lumley J, Chamberlain C, Dowswell T, Oliver S, Oakley L, Watson L. Interventions for promoting smoking cessation during pregnancy. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD001055. doi: 10.1002/14651858.CD001055.pub3.

  PMID: 19588322 RESULT

• Heatherton TF, Kozlowski LT, Frecker RC, Fagerstrom KO. The Fagerstrom Test for Nicotine Dependence: a revision of the Fagerstrom Tolerance Questionnaire. Br J Addict. 1991 Sep;86(9):1119-27. doi: 10.1111/j.1360-0443.1991.tb01879.x.

  PMID: 1932883 RESULT

• Prochaska JO, DiClemente CC. Stages and processes of self-change of smoking: toward an integrative model of change. J Consult Clin Psychol. 1983 Jun;51(3):390-5. doi: 10.1037//0022-006x.51.3.390. No abstract available.

  PMID: 6863699 RESULT

• Prochaska JO, DiClemente CC, Norcross JC. In search of how people change. Applications to addictive behaviors. Am Psychol. 1992 Sep;47(9):1102-14. doi: 10.1037//0003-066x.47.9.1102.

  PMID: 1329589 RESULT

• Weber EU, Johnson EJ, Milch KF, Chang H, Brodscholl JC, Goldstein DG. Asymmetric discounting in intertemporal choice: a query-theory account. Psychol Sci. 2007 Jun;18(6):516-23. doi: 10.1111/j.1467-9280.2007.01932.x.

  PMID: 17576265 RESULT

• Joyce CM, Saulsgiver K, Mohanty S, Bachireddy C, Molfetta C, Steffy M, Yoder A, Buttenheim AM. Remote Patient Monitoring and Incentives to Support Smoking Cessation Among Pregnant and Postpartum Medicaid Members: Three Randomized Controlled Pilot Studies. JMIR Form Res. 2021 Sep 30;5(9):e27801. doi: 10.2196/27801.

  PMID: 34591023 DERIVED

MeSH Terms

Conditions

Tobacco Use Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Alison Buttenheim, PhD, MBA

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Nursing

Study Record Dates

• First Submitted: June 14, 2017
• First Posted: July 6, 2017
• Study Start: July 5, 2017
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2019
• Last Updated: May 9, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)