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Sense2Stop:Mobile Sensor Data to Knowledge

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ClinicalTrials.gov Identifier: NCT03184389
Recruitment Status : Completed
First Posted : June 12, 2017
Last Update Posted : October 4, 2019
Sponsor:
Collaborators:
University of Memphis
Georgia Institute of Technology
University of Minnesota, MN
Ohio State University
University of Massachusetts, Amherst
University of Michigan
University of California, Los Angeles
University of California, San Diego
University of California, San Francisco
University of Utah
Information provided by (Responsible Party):
Bonnie Spring, Northwestern University

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.

Condition or disease Intervention/treatment Phase
Stress Smoking Cessation Overeating Behavioral: Prompt to use smartphone apps for stress management Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : June 23, 2017
Actual Primary Completion Date : August 1, 2019
Actual Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
Within-participant micro-randomization
Each minute when participant is available is randomly assigned to either intervention (to practice a stress management exercise) vs. no intervention prompt. When intervention occurs, participant's smartphone vibrates and relaxation app opens, prompting performance of a relaxation exercise.
Behavioral: Prompt 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.
Other Name: Headspace, Thought Shakeup, MoodSurfing




Primary Outcome Measures :
  1. Probability of being stressed. [ Time Frame: 2 hour window after each micro-randomized intervention vs. no intervention event during first 10 days after quitting smoking ]

Secondary Outcome Measures :
  1. First and all subsequent lapses in smoking cessation. [ Time Frame: 10 days ]
  2. Overeating episodes [ Time Frame: 10 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT03184389


Locations
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United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
University of Memphis
Georgia Institute of Technology
University of Minnesota, MN
Ohio State University
University of Massachusetts, Amherst
University of Michigan
University of California, Los Angeles
University of California, San Diego
University of California, San Francisco
University of Utah
Investigators
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Principal Investigator: Bonnie Spring, PhD Northwestern University

Additional Information:
Publications:
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Responsible Party: Bonnie Spring, Director, Center for Behavior and Health-Institute for Public Health and Medicine (IPHAM); Professor of Preventive Medicine (Behavioral Medicine), Psychiatry, Psychology, and Public Health, Northwestern University
ClinicalTrials.gov Identifier: NCT03184389     History of Changes
Other Study ID Numbers: U54EB020404 ( U.S. NIH Grant/Contract )
First Posted: June 12, 2017    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Following completion of this study, a de-identified dataset, (i.e., containing no raw location/GPS information), will be generated and made available to interested researchers upon request. The dataset will be stripped of any information that could be linked back to the original data or to an individual participant. Prospective users of this dataset must sign a confidentiality agreement, requiring that they must get permission from the MD2K Center to share the data with anyone else. All external requests for data will be directed to Dr. Bonnie Spring and routed through the MD2K Center. Prospective investigators will submit a written proposal to the MD2K Executive Committee outlining the question they will investigate, the specific variables that they need to answer that question, their analytic plan for answering that question, and documentation of sufficient Institutional Review Board oversight. Investigators will also need to sign a confidentiality agreement.

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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 Bonnie Spring, Northwestern University:
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
Additional relevant MeSH terms:
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Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms