Clinical trial NCT03184389: Sense2Stop:Mobile Sensor Data to Knowledge
Official title: Sense2Stop Mobile Sensor Data to Knowledge: Preliminary Study of the Effects of Wearable Sensors and Smartphone Apps on Real Time Stress and Smoking in Recently Quit Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Smoking Cessation
Overeating
Keywords: Behavioral Counseling
Cigarette Smoking
Mobile Health
Heart Rate Variability Monitoring
Mindfulness-Based Exercises
Mobile Apps
Physiological Monitoring
Respiratory Pattern Monitoring
Stress-Management Interventions
Sensor-Triggered Stress Intervention
Smartphone Apps
Smoking Cessation
Wearable Sensors
Eating Behavior
Stress-Related Eating
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: University of Memphis
name: Georgia Institute of Technology
name: University of Minnesota
name: Ohio State University
name: University of Massachusetts, Amherst
name: University of Michigan
name: University of California, Los Angeles
name: University of California, San Diego
name: University of California, San Francisco
name: University of Utah
First posted: 2017-06-12
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Each time point when participant is available (i.e., not driving, not physically active, a stress classification is possible, hasn't recently received an ecological momentary assessment (EMA) or an intervention prompt) is randomly assigned to intervention prompt or no prompt.
Primary purpose: PREVENTION

Brief summary: The aim of this research is to build systems that can recognize when people are stressed and then provide them with relaxation prompts in the moment to reduce their likelihood of being stressed, smoking, or overeating in the near future. Using these systems should help smokers be more effective in their attempts to quit by reducing their tendency to lapse when they are stressed or experiencing other negative moods or behaviors.

Detailed description: The purpose of this study is (1) to evaluate the feasibility of a just-in-time intervention to decrease stress in recently quit smokers; and (2) to examine whether a just-in-time adaptive intervention that decreases stress also reduces the near-term odds of a smoking lapse.

The primary hypothesis of this study is that the administration of a prompt to perform a relaxation exercise as compared to no prompt will lead to a lower likelihood of being stressed in the subsequent two hours, and that this effect will be stronger when the prompt is administered when the individual is stressed. The secondary hypothesis is that stress episodes will predict the timing of smoking lapses. The third hypothesis is that administration of a prompt to perform a relaxation exercise will reduce the odds of smoking for the next two hours, and that this effect will be stronger when the prompt is administered when the individual is stressed. The fourth (exploratory) hypothesis is that stress will predict the timing of overeating episodes.

These data will also be used for developing automated risk prediction of smoking relapse, and for developing decision rules for the timing of Just-In-Time-Adaptive Interventions (JITAIs).

Eligibility criteria: Inclusion Criteria:

* Smokes 1+ cigarettes/day for past year
* Willing to try to quit smoking for at least 48 hours during a 15-day quit trial
* Will not use non-cigarette tobacco products or nicotine replacement therapy during the study period
* Not taking or intending to take pharmacological smoking cessation aids (e.g., nicotine replacement, bupropion, venlafaxene) during the study period

Exclusion Criteria:

* Unable to wear study devices due to skin irritation or sizing limitations
* Planning to move outside of Chicago area during study period
* Adults unable to provide informed consent
* Individuals who are not yet adults
* Pregnant women
* Prisoners
* Non-English Speakers

Primary outcomes:
measure: Probability of being stressed.
timeFrame: 2 hour window after each micro-randomized intervention vs. no intervention event during first 10 days after quitting smoking
Secondary outcomes:
measure: First and all subsequent lapses in smoking cessation.
timeFrame: 10 days
measure: Overeating episodes
timeFrame: 10 days
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Bonnie Spring, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Saleheen N, Ali AA, Hossain SM, Sarker H, Chatterjee S, Marlin B, Ertin E, al'Absi M, Kumar S. puffMarker: A Multi-Sensor Approach for Pinpointing the Timing of First Lapse in Smoking Cessation. Proc ACM Int Conf Ubiquitous Comput. 2015 Sep;2015:999-1010.
citation: Kumar S, Abowd GD, Abraham WT, al'Absi M, Beck JG, Chau DH, Condie T, Conroy DE, Ertin E, Estrin D, Ganesan D, Lam C, Marlin B, Marsh CB, Murphy SA, Nahum-Shani I, Patrick K, Rehg JM, Sharmin M, Shetty V, Sim I, Spring B, Srivastava M, Wetter DW. Center of excellence for mobile sensor data-to-knowledge (MD2K). J Am Med Inform Assoc. 2015 Nov;22(6):1137-42. doi: 10.1093/jamia/ocv056. Epub 2015 Jul 3.
citation: Sarker H, Tyburski M, Rahman MM, Hovsepian K, Sharmin M, Epstein DH, Preston KL, Furr-Holden CD, Milam A, Nahum-Shani I, al'Absi M, Kumar S. Finding Significant Stress Episodes in a Discontinuous Time Series of Rapidly Varying Mobile Sensor Data. Proc SIGCHI Conf Hum Factor Comput Syst. 2016 May;2016:4489-4501. doi: 10.1145/2858036.2858218.
citation: Klasnja P, Hekler EB, Shiffman S, Boruvka A, Almirall D, Tewari A, Murphy SA. Microrandomized trials: An experimental design for developing just-in-time adaptive interventions. Health Psychol. 2015 Dec;34S(0):1220-8. doi: 10.1037/hea0000305.