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

NCT07789496 | Not Yet Recruiting

• 2 other identifiers: SON-2024-32759STUDY00022693
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Smoking Cessation; Cigarette Smoking; Tobacco Use; Nicotine Dependence

Keywords

Mindful smoking; Smoking cessation; Mindfulness; Smartphone-based sensor-band; WHOOP sensor-band; Tobacco cessation

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (12)

• 8-week smoking abstinence rate

  8 weeks

• 8-week smoking reduction

  Baseline to 8 weeks

• 4-month smoking abstinence rate

  4 months after completion of the intervention

• 4-month smoking reduction

  Baseline to 4 months after completion of the intervention

• Stress level

  Baseline to 8 weeks

Study Arms (2)

Mindful Smoking and Sensor-Band Intervention

EXPERIMENTAL

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

Smoking Cessation Information Control

ACTIVE COMPARATOR

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

Interventions

Mindful Smoking and Sensor-Band Intervention BEHAVIORAL

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.

Also known as: Quit With Sense

Mindful Smoking and Sensor-Band Intervention

Smoking Cessation Information BEHAVIORAL

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.

Smoking Cessation Information Control

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota School of Nursing

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Smoking Cessation; Cigarette Smoking; Tobacco Use; Tobacco Use Disorder; Tobacco Use Cessation

Interventions

Sensation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Tobacco Smoking; Smoking; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Fang Lei, PhD, MSN, MPH, RN

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fang Lei, PhD, MSN, MPH, RN

CONTACT

612-626-7021; flei@umn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes will be assessed by research team members blinded to the intervention assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to either the mindful smoking and smartphone-based sensor-band intervention group or the smoking cessation information control group. Participants in the intervention group will receive mindful smoking guidance, sensor-band instructions, a mindfulness practice video, and smoking cessation information. Participants in the control group will receive smoking cessation information.

Study Record Dates

• First Submitted: August 3, 2026
• First Posted: August 27, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 27, 2026

Record last verified: 2026-08

Locations

US (1)