Quit With Sense: Using Mindful Smoking and Wearable Device for Smoking Cessation

Quit With Sense: A Pilot Smoking Cessation Intervention Study Using Mindful Smoking and Smartphone-Based Sensor-Band

This pilot randomized controlled trial will test the feasibility of a smoking cessation intervention using mindful smoking practice and a smartphone-based sensor-band among adults who regularly smoke cigarettes.

Participants will be randomized to either an intervention group or a control group. Participants in the intervention group will receive a one-on-one mindful smoking guidance session, instructions for using a smartphone-based sensor-band, a mindfulness practice video, and smoking cessation information. Participants in the control group will receive smoking cessation information. The intervention period will last 8 weeks, with assessments at baseline, 8 weeks, and 4 months after completion of the intervention.

The study will evaluate feasibility, preliminary smoking cessation outcomes, and physiologic parameters including heart rate variation, skin temperature, resting heart rate, respiratory rate, and real-time heart rate during craving and mindful smoking practice.

Study Overview

• Status: Not yet recruiting
• Conditions: Smoking Cessation; Tobacco Use; Nicotine Dependence; Cigarette Smoking
• Intervention / Treatment: Behavioral: Mindful Smoking and Sensor-Band Intervention; Behavioral: Smoking Cessation Information

Detailed Description

Cigarette smoking is a leading preventable cause of morbidity and mortality and contributes to cancer, lung disease, health care costs, and reduced quality of life. Although many adults who smoke cigarettes attempt to quit, long-term cessation rates remain low. Mindfulness-based strategies may help people who smoke manage cravings by increasing awareness of present-moment thoughts, emotions, and physical sensations without automatically reacting by smoking.

This pilot randomized controlled trial will evaluate a smoking cessation intervention that combines mindful smoking practice with use of a smartphone-based sensor-band. The study will enroll 30 adults who regularly smoke cigarettes and are motivated to quit smoking or make a quit attempt. Participants will be randomly assigned to an intervention group or a control group, with approximately 15 participants in each group.

Participants in the intervention group will receive a one-hour, one-on-one, in-person mindful smoking guidance session from a certified mindfulness instructor. The session will teach participants to manage cravings mindfully using the RAIN method: Recognize, Accept, Investigate, and Note. Participants will also receive a mindfulness practice video for home practice and in-person instruction from a research assistant on use of the smartphone-based sensor-band. During the 8-week self-management and intervention period, participants in the intervention group will be instructed to practice mindful smoking when they feel a craving to smoke. They will be asked to record their craving level, duration of mindful smoking practice, feelings after mindful smoking, heart rate at the time of craving, heart rate at the end of mindful smoking practice, and daily cigarette smoking activities.

Participants in the control group will receive smoking cessation information published by the American Lung Association, including printed smoking cessation materials. Control group participants will be asked to record their daily cigarette smoking activities.

Data will be collected at baseline, 8 weeks after the intervention begins, and 4 months after the intervention is completed. Feasibility will be assessed by recruitment rate, time to recruit the target sample, intervention uptake rate, attrition rate, and participant satisfaction. Preliminary effectiveness will be assessed by 8-week and 4-month smoking abstinence rates and smoking reduction. Smoking abstinence will be confirmed using exhaled carbon monoxide measurement. The study will also assess stress level, self-control and management level, mindfulness level, heart rate variation, skin temperature, resting heart rate, respiratory rate, and real-time heart rate during craving and mindful smoking practice.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fang Lei, PhD, MSN, MPH, RN; Phone Number: 612-626-7021; Email: flei@umn.edu

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota School of Nursing
      • Contact: Fang Lei, PhD, MSN, MPH, RN; Phone Number: 612-626-7021; Email: flei@umn.edu
      • Principal Investigator: Fang Lei, PhD, MSN, MPH, RN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Aged 18 years and older
• Smoking at least 5 cigarettes per day on average over the past 3 months
• Motivated to quit smoking, indicated by answering "yes" to being interested in quitting smoking or making a quit attempt in the next 30 days
• Has a functioning Android or iOS smartphone
• Has a telephone number available for contact

Exclusion Criteria:

• Recent change in the dosage or type of new medications, if taking medications, or unstable medical situation in the past 3 months
• Active substance dependence other than nicotine
• Use of other non-cigarette tobacco products, including e-cigarettes, more than 15 days per month
• Another household member enrolled in the study
• Participation in a smoking cessation program in the past 30 days

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindful Smoking and Sensor-Band Intervention; Participants in this arm will receive a one-hour, one-on-one mindful smoking guidance session from a certified mindfulness instructor, instruction on use of the smartphone-based sensor-band, a mindfulness practice video for home practice, and smoking cessation information. During the 8-week intervention period, participants will be instructed to practice mindful smoking when they feel a craving to smoke and to record craving level, duration of mindful smoking practice, feelings after practice, heart rate at craving time, heart rate at the end of mindful smoking practice, and daily cigarette smoking activities.	Behavioral: Mindful Smoking and Sensor-Band Intervention; The intervention includes a one-hour, one-on-one mindful smoking guidance session using the RAIN method, which includes Recognize, Accept, Investigate, and Note. Participants will also receive a mindfulness practice video and instructions for using a smartphone-based sensor-band. During the 8-week intervention period, participants will practice mindful smoking when they feel a craving to smoke and will record craving level, duration of practice, feelings after practice, heart rate at craving time, heart rate at the end of mindful smoking practice, and daily smoking activities.; Other Names: Quit With Sense
Active Comparator: Smoking Cessation Information Control; Participants in this arm will receive smoking cessation information published by the American Lung Association, including printed smoking cessation materials. Participants will be asked to record their daily cigarette smoking activities in a paper notebook.	Behavioral: Smoking Cessation Information; Participants will receive smoking cessation information published by the American Lung Association, including printed materials such as The Smoking Health Effects brochure and Top Tips for Quitting Smoking.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment rate	Recruitment rate will be measured as the proportion of eligible participants who agree to participate in the study.	Baseline / recruitment period, up to 6 months
Time to recruit target sample	Time to recruit the target sample will be measured as the duration of time required to recruit the target sample size.	Up to 6 months
Intervention uptake rate	Intervention uptake rate will be measured as the percentage of participants who complete the intervention.	8 weeks
Attrition rate	Attrition rate will be measured as the percentage of participants who drop out before completing the study.	Up to 4 months after completion of the 8-week intervention
Client satisfaction	Client satisfaction will be assessed using the Satisfaction Feedback Questionnaire, adapted from the Client Satisfaction Questionnaire. It has 4 questions with ordinal level options. The value of the scare measurement ranges from 0 to 12. Higher score means a higher satisfaction level.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
8-week smoking abstinence rate	Smoking abstinence at 8 weeks will be measured as the percentage of participants who quit smoking at the 8-week time point. Abstinence will be confirmed by exhaled carbon monoxide measurement level of less than 8 ppm.	8 weeks
8-week smoking reduction	Smoking reduction at 8 weeks will be measured as the reduction in the mean number of cigarettes smoked per day from baseline to the 8-week time point.	Baseline to 8 weeks
4-month smoking abstinence rate	Smoking abstinence at 4 months after intervention completion will be measured as the percentage of participants who quit smoking at the 4-month follow-up time point. Abstinence will be confirmed by exhaled carbon monoxide measurement level of less than 8 ppm.	4 months after completion of the intervention
4-month smoking reduction	Smoking reduction at 4 months after intervention completion will be measured as the reduction in the mean number of cigarettes smoked per day from baseline to the 4-month follow-up time point.	Baseline to 4 months after completion of the intervention
Stress level	Stress level will be assessed using the Perceived Stress Scale. It has 10 questions with ordinal level options. The value of the scare measurement ranges from 0 to 40. Higher score means a higher stress level.	Baseline to 8 weeks
Self-control and management level	Self-control and management level will be assessed using the Self-control and Management Scale. It has 16 questions with ordinal level options. The value of the scare measurement ranges from 0 to 80. Higher score means a higher self-control and management level.	Baseline to 8 weeks
Mindfulness level	Mindfulness level will be assessed using the Mindful Attention Awareness Scale. It has 15 questions with ordinal level options. The value of the scare measurement ranges from 0 to 75. Higher score means a higher mindful attention awareness level.	Baseline to 8 weeks
Respiratory Rate Measured by Smartphone-Based Sensor-Band	Respiratory rate will be measured in breaths per minute using the smartphone-based sensor-band among intervention group participants.	During the 8-week intervention period
Heart Rate Variability Measured by Smartphone-Based Sensor-Band	Physiologic parameters including respiratory rate, heart rate variation, skin temperature, and resting heart rate will be collected using the smartphone-based sensor-band among intervention group participants. Physiologic parameters including respiratory rate measured by breaths per minute, heart rate variation measured by milliseconds, skin temperature measured by Farehent degree, and resting heart rate measured by heart beats per minute, will be collected using the smartphone-based sensor-band among intervention group participants.	During the 8-week intervention period
Skin Temperature Measured by Smartphone-Based Sensor-Band	Skin temperature will be measured in degrees Fahrenheit using the smartphone-based sensor-band among intervention group participants.	During the 8-week intervention period
Resting Heart Rate Measured by Smartphone-Based Sensor-Band	Resting heart rate will be measured in beats per minute using the smartphone-based sensor-band among intervention group participants.	During the 8-week intervention period
Heart rate during craving and mindful smoking practice	Real-time heart rate will be measured at the time of cigarette craving and at the end of mindful smoking practice among intervention group participants.	During the 8-week intervention period

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Fang Lei, PhD, MSN, MPH, RN, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: August 3, 2026
• First Submitted That Met QC Criteria: August 24, 2026
• First Posted (Actual): August 27, 2026

Study Record Updates

• Last Update Posted (Actual): August 27, 2026
• Last Update Submitted That Met QC Criteria: August 24, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Mindfulness; Smoking cessation; Tobacco cessation; Mindful smoking; Smartphone-based sensor-band; WHOOP sensor-band
• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Behavior; Smoking; Health Behavior; Tobacco Smoking; Tobacco Use Disorder; Smoking Cessation; Cigarette Smoking; Tobacco Use; Tobacco Use Cessation; Musculoskeletal and Neural Physiological Phenomena; Nervous System Physiological Phenomena; Sensation
• Other Study ID Numbers: SON-2024-32759; STUDY00022693 (Other Identifier: University Of Minnesota)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No