An observational study in Smoking, sponsored by National Institute on Minority Health and Health Disparities (NIMHD). Enrolling by invitation at 1 site in United States. Open to participants aged 21 Years to 120 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by National Institute on Minority Health and Health Disparities (NIMHD) · Observational
Background: It is important to quickly identify when people are at risk of smoking. Most current methods rely on people reporting when they smoke or what makes them want to smoke. But this can be hard for people to do and may not always be accurate. Other methods use special gadgets to identify smoking movements, but these may not always work well in real life. We want to see if we can use devices available on the market such as smartwatches to identify signs in the body and hand movements that might indicate when someone is about to smoke, is currently smoking, or has just smoked.
Objective: To record body signs and hand movements before, during, and after smoking in real-life and in a lab to see how they change when someone is craving cigarettes, while a person is smoking, and after a person has smoked.
Eligibility: People who are 21 years or older and smoke, have no college degree or be currently enrolled in college, and are low-income earners. To participate in the study, participants have to pass a breath test that shows they smoke cigarettes and, for women, a urine test to show that they are not currently pregnant.
Design: Participants will complete an eligibility survey to see if they qualify to be in the study. If they qualify, they will answer a brief baseline survey that includes questions about themselves, their health, and their smoking behavior.
Participants will get a smartwatch to wear for 3 days at home, log each time they are about to smoke and have finished smoking, and answer a 5-question health survey via the app. They will get instructions on how to set up and wear the smartwatch. They will download a mobile application on their phone. The app will collect data from the smartwatch.
Participants will then come to the lab but will be asked not to smoke or drink alcohol for at least 12 hours. They will have to take a breath test to show they have not smoked or had alcohol. They will also give a blood sample. In the lab, they will sit in a room where they will be hooked to devices that monitor their vitals such as heart rate and blood pressure for one hour. They will also wear a smartwatch on each hand. While they are in the smoking room, they will go through 3 different phases: (a) pre-smoking where they will be asked to stay seated for about 25 minutes, (b) smoking where they will be asked to smoke as many cigarettes of their choice as they want for about 10 to 15 minutes, (c) post-smoking where they will be asked to stay seated, not smoking, for about 25 minutes. They will answer a brief 10-minute health survey before and after the session.
Participation will last for 3 days of home monitoring and 2 visits to the research clinic that last about 2 hours.
Background:
The study is part of a systematic effort to develop and evaluate a smoking cessation intervention, Quit Journey, a smoking cessation intervention targeting individuals with low socioeconomic status. Specifically, the study will inform the development of just-in-time momentary support to preempt a lapse or prevent it from progressing to a relapse to users of Quit Journey. Additionally, the study fills a gap in wearable-based studies for smoking detection that have thus far relied exclusively on socially and economically advantaged populations by increasing the representation of underserved populations and more accurately developing algorithms for smoking detection that include input from minority populations and pave the way for its replication with a larger sample in real-world settings. Finally, the data collected from this laboratory-based study will serve as baseline parameters for detecting smoking events in free-living conditions. In a planned real-world study, we aim to finetune our smoking-detection algorithms with data collected in natural environments, potentially improving their robustness and generalizability. Insights from this study have real-world applications of smoking-detection algorithms in wearables and mobile applications, ultimately advancing technology-assisted smoking cessation and contributing to reduced smoking rates.
Objectives:
Endpoints:
1,509 studies on the registry are indexed under Smoking; 193 are open to participants now.
This study's planned enrollment of 30 is below the median of 150 across 301 observational studies indexed under Smoking.
Browse Smoking studies →National Institute on Minority Health and Health Disparities (NIMHD) is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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The study population will comprise individuals aged 21 years or older who currently smoke cigarettes. Participants must have completed a high school education or possess a lower level of academic achievement, and they should be classified as low-income earners. To be eligible for participation in the study, individuals will need to successfully pass a breath test that confirms their smoking status. Furthermore, female participants will be required to undergo a urine test to verify that they are not currently pregnant, ensuring the study's safety and ethical standards. This rigorous participant selection process is designed to ensure a focused and relevant study group that aligns with the research objectives.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
We will recruit up to 30 non-treatment seeking participants with low socioeconomic status who smoke. We will strive to have representation across racial and ethnic groups and biological sex. At least half of the participants must earn at or below 200% of the federal poverty guideline for 2024 corresponding to number of people in their household (US Department of Health and Human Services).
To be included in the study, participants must:
EXCLUSION CRITERIA:
Participants will be excluded if they:
Vulnerable populations will not be enrolled in the study (i.e., adults unable to consent, individuals who are not yet adults, pregnant women, prisoners).
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Individuals aged 21 and older who smoke, have not gone beyond a high school education, and earn low incomes.
The primary endpoint is to evaluate changes in biomarker measurements obtained from wearables, which include heart rate, heart rate variability, respiratory rate, blood oxygen levels & hand/arm movement, across three smoking stages.
As the research progresses, the team will work diligently to gather a robust dataset from various sources, including wearable devices, lab sessions, medical-grade information, and detailed questionnaires. This comprehensive approach will enable the identification of specific biomarkers and hand-mouth gestures related to the different stages of tobacco use: pre-smoking, active smoking, and post-smoking. By analyzing these diverse data sources, the team aims to gain valuable insights into the physiological and behavioral patterns associated with each stage. This knowledge will not only enrich our understanding of tobacco use but also pave the way for developing targeted interventions and tailored support systems for individuals seeking to quit smoking. Through collaboration and innovative analysis, this research endeavors to create more effective strategies for smoking cessation, ultimately fostering healthier lifestyles.
Time frame: 7 days
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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National Institute on Minority Health and Health Disparities (NIMHD) →