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Sense2Stop:Mobile Sensor Data to Knowledge

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03184389
Enrollment
75
Registered
2017-06-12
Start date
2017-06-23
Completion date
2019-08-01
Last updated
2019-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overeating, Smoking Cessation, Stress

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

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).

Interventions

BEHAVIORALPrompt to use smartphone apps for stress management

Study smartphone and software will be used to deliver intervention prompts to use stress management applications on the study smartphone at various times throughout the day, during at least 10 days of study participation. The delivery of prompts will be micro randomized to occur when participants are classified as stressed, and when participants are not classified as stressed. Headspace, a commercial stress management application, will be installed on the study smartphones. Thought Shakeup and Mood Surfing, stress management applications that are not commercially available, also will be installed on the study smartphones. These smartphone applications guide participants through stress management exercises that draw upon techniques from mindfulness, cognitive behavioral therapy, and acceptance and commitment therapy.

Sponsors

University of Memphis
CollaboratorOTHER
Georgia Institute of Technology
CollaboratorOTHER
University of Minnesota
CollaboratorOTHER
Ohio State University
CollaboratorOTHER
University of Massachusetts, Amherst
CollaboratorOTHER
University of Michigan
CollaboratorOTHER
University of California, Los Angeles
CollaboratorOTHER
University of California, San Diego
CollaboratorOTHER
University of California, San Francisco
CollaboratorOTHER
University of Utah
CollaboratorOTHER
Northwestern University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Probability of being stressed.2 hour window after each micro-randomized intervention vs. no intervention event during first 10 days after quitting smoking

Secondary

MeasureTime frame
First and all subsequent lapses in smoking cessation.10 days
Overeating episodes10 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026