Sense2Stop:Mobile Sensor Data to Knowledge

NCT03184389 | Completed

• 1 other identifier: U54EB020404
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Probability of being stressed.

  2 hour window after each micro-randomized intervention vs. no intervention event during first 10 days after quitting smoking

Secondary Outcomes (2)

• First and all subsequent lapses in smoking cessation.

  10 days

• Overeating episodes

  10 days

Study Arms (1)

Within-participant micro-randomization

OTHER

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

Interventions

Prompt to use smartphone apps for stress management BEHAVIORAL

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.

Also known as: Headspace, Thought Shakeup, MoodSurfing

Within-participant micro-randomization

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• University of Memphis: collaborator
• Georgia Institute of Technology: collaborator
• University of Minnesota: collaborator
• Ohio State University: collaborator
• University of Massachusetts, Amherst: collaborator
• University of Michigan: collaborator
• University of California, Los Angeles: collaborator
• University of California, San Diego: collaborator
• University of California, San Francisco: collaborator
• University of Utah: collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (4)

• 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.

  PMID: 26543927 BACKGROUND

• 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.

  PMID: 26555017 BACKGROUND

• 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.

  PMID: 28058409 BACKGROUND

• 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.

  PMID: 26651463 BACKGROUND

Related Links

• The Mobile Sensor Data-to-Knowledge Center of Excellence is one of 13 national Big Data Centers of Excellence awarded by the National Institutes of Health as part of its Big Data-to-Knowledge initiative.

MeSH Terms

Conditions

Smoking Cessation; Hyperphagia; Cigarette Smoking; Feeding Behavior

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Tobacco Smoking; Smoking; Tobacco Use; Behavior, Animal

Study Officials

• Bonnie Spring, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Behavior and Health-Institute for Public Health and Medicine (IPHAM); Professor of Preventive Medicine (Behavioral Medicine), Psychiatry, Psychology, and Public Health

Model Details: 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.

Study Record Dates

• First Submitted: June 8, 2017
• First Posted: June 12, 2017
• Study Start: June 23, 2017
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: October 4, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)