Smoking Cessation Intervention for Young Adults Using MTM: A Randomized Controlled Trial

NCT07104006 | Not Yet Recruiting DMC

• 1 other identifier: IRB #: UNLV-2025-174
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate whether a Multi-Theory Model (MTM)-based behavioral intervention can effectively promote smoking cessation and support behavior change in young adult cigarette smokers aged 18 to 29 in the United States. This trial focuses on whether applying theory-driven strategies such as emotional transformation, behavioral confidence, and participatory dialogue can lead to higher smoking abstinence rates and improved psychosocial outcomes compared to a standard knowledge-based smoking education control group. The main questions it aims to answer are:

• Does the intervention lead to a greater reduction in nicotine dependence scores (measured by the Fagerström Test for Nicotine Dependence \[FTND\]) and an increase in quit rate among young adult smokers from baseline to 12-week follow-up?
• Does the MTM-based intervention significantly improve 7-day point prevalence abstinence (PPA) at 12 weeks compared to a knowledge-based control group?
• Does the intervention result in significant positive changes in MTM constructs such as participatory dialogue, behavioral confidence, emotional transformation, practice for change, and changes in the physical and social environment from baseline to 12-week follow-up? Researchers will compare the MTM-based intervention group (experimental arm) to a knowledge-based smoking education control group to determine whether the theory-driven program is more effective in supporting smoking cessation and behavior change among young adult smokers. Participants will:
• Complete surveys at three time points: baseline (Week 0), post-intervention (Week 5), and follow-up (Week 12), covering demographics, smoking history, nicotine dependence (FTND), MTM constructs (via a validated 48-item scale), and self-reported quit rates.
• Be randomly assigned to one of two groups: o MTM-Based Intervention Group: Attend four weekly 90-minute virtual group sessions covering: Week 1: Participatory dialogue, behavioral confidence, and process evaluation Week 2: Emotional transformation, environmental restructuring, and process evaluation Week 3: Practice for change, relapse prevention, and process evaluation Week 4: Social support, reward systems, and process evaluation o Knowledge-Based Control Group: Attend four weekly 90-minute didactic virtual sessions focused on: Smoking-related health risks Overview of FDA-approved smoking cessation tools
• Undergo process evaluations using the RQFSM model (Reach, Quality, Fidelity, Satisfaction, and Management) at the end of the intervention to assess how well each program was delivered and perceived.
• Have the optional opportunity for biochemical verification of smoking abstinence using exhaled carbon monoxide (CO) testing. This trial will be conducted entirely online and follows a randomized controlled trial (RCT) design with a 1:1 group allocation ratio. A total of 144 participants (approximately 72 per group) will be recruited, accounting for an expected attrition rate of up to 50%. This sample size was chosen to ensure sufficient power to detect statistically significant differences between the two groups (effect size f = 0.25, α = 0.05, power = 0.80). Although the intervention will be delivered virtually, the study is affiliated with the University of Nevada, Las Vegas (UNLV), which provides IRB approval, secure data storage infrastructure, and institutional oversight (IRB Protocol #2024-453). Informed consent will be obtained electronically, and all participant data will be securely stored using encrypted Qualtrics surveys and password-protected UNLV or Google Drive servers with limited access, ensuring full confidentiality and ethical compliance. This trial addresses a pressing public health challenge: the persistent difficulty young adults face in quitting smoking despite decades of tobacco control efforts. Young adults remain a high-risk population for relapse and are frequently underserved by conventional cessation programs. This MTM-based intervention seeks to fill this gap by targeting both behavioral and environmental barriers through structured, evidence-based strategies designed to build self-efficacy, emotional readiness, and environmental support. The use of MTM constructs such as emotional transformation, behavioral confidence, and restructuring the physical/social environment is a key innovation that may enhance long-term cessation outcomes. Moreover, delivering the program virtually increases its potential for scalability and real-world application, making it a promising model for public health programs nationwide. The findings of this clinical trial will be disseminated through peer-reviewed journal articles, national public health conferences (APHA, SOPHE etc.), and shared with stakeholders like the CDC's Office on Smoking and Health. The results may help shape future funding priorities, guide the development of policy, and inform the design of tailored interventions for smoking cessation among young adults.

Conditions

Tobacco Use Disorder/Cigarette Smoking

Keywords

Smoking cessation intervention; Multi-Theory Model (MTM) of Behavior Change; Young adults; Randomized controlled trial (RCT)

Outcome Measures

Primary Outcomes (2)

• Fagerström Test for Nicotine Dependence (FTND) measure

  This outcome measures changes in nicotine dependence using the Fagerström Test for Nicotine Dependence (FTND), a validated 6-item questionnaire assessing the intensity of physical addiction to nicotine. Scores range from 0 to 10, with higher scores indicating greater dependence. Participants complete the FTND at baseline (pre-intervention) and again at the 12-week follow-up. The difference in scores over time is used to evaluate whether the intervention reduces nicotine dependence among young adult smokers. This helps assess the impact of the intervention beyond smoking cessation, providing insight into reductions in the psychological and physiological aspects of tobacco addiction. Repeated Measures Analysis of Covariance (ANCOVA) will be used to examine changes in continuous outcomes (e.g., MTM construct scores, FTND scores) across the three time points. Baseline values and individual-level covariates (e.g., age, gender, baseline dependence) will be included as covariates.

  Baseline to 12 week followup

• 7-day point prevalence abstinence (PPA)

  The 7-day point prevalence abstinence (PPA) measures whether participants have refrained from smoking defined as no tobacco use, not even a single puff during the 7 days prior to the 12-week follow-up. This outcome is assessed through participant self-report using a standardized questionnaire. To enhance accuracy, abstinence may be optionally validated using a carbon monoxide (CO) breath analyzer, with CO levels ≤6 parts per million (ppm) indicating non-smoking status. This measure helps determine the short-term effectiveness of the intervention in promoting smoking cessation among young adults.

  12-week follow-up after baseline assessment

Secondary Outcomes (2)

• Changes in mean scores of MTM constructs using a validated 28-item MTM instrument

  Time of enrollment to 12 week followup

• Quit rate

  Baseline to 12-week follow-up

Study Arms (2)

Knowledge-Based Smoking Risk Education and Quit Strategies

ACTIVE COMPARATOR

Participants are individually randomized to the control arm receive a four-week educational program focusing on basic information about the health risks of smoking and effective quitting techniques. The program consists of weekly 90-minute sessions delivered in an online format to maximize participant reach and accessibility. Sessions cover topics such as smoking-related health consequences, benefits of quitting, common barriers to cessation, and practical strategies for quitting smoking. Unlike the experimental arm, this program does not include behavior change techniques grounded in the Multi-Theory Model but instead emphasizes increasing awareness and knowledge to motivate cessation. This active comparator arm serves to control for time and attention while providing participants with standard smoking cessation information.

Behavioral: Multi-Theory Model (MTM)-Based Smoking Cessation Program

Multi-Theory Model-Based Smoking Cessation Intervention

EXPERIMENTAL

This arm delivers a four-week smoking cessation intervention grounded in the Multi-Theory Model (MTM) of health behavior change. Participants are individually randomized into two arms of the study to ensure comparability between groups and reduce selection bias. The intervention comprises weekly 90-minute sessions delivered entirely online, with a focus on core MTM constructs: participatory dialogue, behavioral confidence, emotional transformation, practice for change, and changes in physical and social environment. Session activities include storytelling, interactive discussions weighing quitting pros and cons, confidence-building exercises, role-playing high-risk situations, emotional expression and transformation techniques, development of supportive social networks, stress management tools, reflection and reward practices, and commitment reinforcement through letters and group sharing.

Behavioral: Multi-Theory Model (MTM)-Based Smoking Cessation Program

Interventions

Multi-Theory Model (MTM)-Based Smoking Cessation Program BEHAVIORAL

Multi-Theory Model (MTM)-Based Smoking Cessation Program: A four-week online smoking cessation program based on the Multi-Theory Model (MTM). It uses behavior change strategies including participatory dialogue, building confidence, emotional transformation, practice for change, and changes in physical and social environment. Activities include storytelling, role-playing high-risk situations, emotional regulation, social support, stress management, reflection, and commitment exercises. The goal is to help young adults initiate and maintain quitting smoking. Knowledge-Based Smoking Risk Education and Quit Strategies Program: A four-week, online educational program providing information on smoking risks, benefits of quitting, barriers, and practical quit strategies. This control arm focuses on increasing knowledge and awareness but does not include MTM-based behavior change techniques.

Knowledge-Based Smoking Risk Education and Quit Strategies; Multi-Theory Model-Based Smoking Cessation Intervention

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Aged 18-29 years
• Current smoker (defined as having smoked at least one cigarette daily over the past 7 days)
• Resident of the United States
• Able to read and understand English

You may not qualify if:

• Use of non-cigarette tobacco products (e.g., vaping, smokeless tobacco)
• Participation in any other smoking cessation program
• Pregnant or planning to become pregnant during the study period
• Dual or poly-substance users, including alcohol or illicit drugs.

Sponsors & Collaborators

• University of Nevada, Las Vegas: lead

Study Sites (1)

University of Nevada, Las Vegas

Las Vegas, Nevada, 89154, United States

Location

Related Publications (10)

• Zhou X, Wei X, Cheng A, Liu Z, Su Z, Li J, Qin R, Zhao L, Xie Y, Huang Z, Xia X, Liu Y, Song Q, Xiao D, Wang C. Mobile Phone-Based Interventions for Smoking Cessation Among Young People: Systematic Review and Meta-Analysis. JMIR Mhealth Uhealth. 2023 Sep 12;11:e48253. doi: 10.2196/48253.

  PMID: 37706482 BACKGROUND

• Schnoll RA, Johnson TA, Lerman C. Genetics and smoking behavior. Curr Psychiatry Rep. 2007 Oct;9(5):349-57. doi: 10.1007/s11920-007-0045-3.

  PMID: 17915073 BACKGROUND

• Rigotti NA, DiFranza JR, Chang Y, Tisdale T, Kemp B, Singer DE. The effect of enforcing tobacco-sales laws on adolescents' access to tobacco and smoking behavior. N Engl J Med. 1997 Oct 9;337(15):1044-51. doi: 10.1056/NEJM199710093371505.

  PMID: 9321533 BACKGROUND

• Ravi K, Indrapriyadharshini K, Madankumar PD. Application of Health Behavioral Models in Smoking Cessation - A Systematic Review. Indian J Public Health. 2021 Apr-Jun;65(2):103-109. doi: 10.4103/ijph.IJPH_1351_20.

  PMID: 34135176 BACKGROUND

• Liu ST, Snyder K, Tynan MA, Wang TW. Youth Access to Tobacco Products in the United States, 2016-2018. Tob Regul Sci. 2019 Nov;5(6):491-501. doi: 10.18001/TRS.5.6.2.

  PMID: 31745494 BACKGROUND

• Green R, Meredith LR, Mewton L, Squeglia LM. Adolescent Neurodevelopment Within the Context of Impulsivity and Substance Use. Curr Addict Rep. 2023 Jun;10(2):166-177. doi: 10.1007/s40429-023-00485-4. Epub 2023 May 2.

  PMID: 38009082 BACKGROUND

• Chen-Sankey JC, Unger JB, Bansal-Travers M, Niederdeppe J, Bernat E, Choi K. E-cigarette Marketing Exposure and Subsequent Experimentation Among Youth and Young Adults. Pediatrics. 2019 Nov;144(5):e20191119. doi: 10.1542/peds.2019-1119.

  PMID: 31659003 BACKGROUND

• Chassin L, Presson CC, Pitts SC, Sherman SJ. The natural history of cigarette smoking from adolescence to adulthood in a midwestern community sample: multiple trajectories and their psychosocial correlates. Health Psychol. 2000 May;19(3):223-31.

  PMID: 10868766 BACKGROUND

• Brown RA, Abrantes AM, Minami H, Prince MA, Bloom EL, Apodaca TR, Strong DR, Picotte DM, Monti PM, MacPherson L, Matsko SV, Hunt JI. Motivational Interviewing to Reduce Substance Use in Adolescents with Psychiatric Comorbidity. J Subst Abuse Treat. 2015 Dec;59:20-9. doi: 10.1016/j.jsat.2015.06.016. Epub 2015 Jul 3.

  PMID: 26362000 BACKGROUND

• Barrington-Trimis JL, Braymiller JL, Unger JB, McConnell R, Stokes A, Leventhal AM, Sargent JD, Samet JM, Goodwin RD. Trends in the Age of Cigarette Smoking Initiation Among Young Adults in the US From 2002 to 2018. JAMA Netw Open. 2020 Oct 1;3(10):e2019022. doi: 10.1001/jamanetworkopen.2020.19022.

  PMID: 33021650 BACKGROUND

Related Links

• Centers for Disease Control and Prevention. (2022). National Health Interview Survey. Centers for Disease Control and Prevention.
• National Academies of Sciences, Engineering, and Medicine. (2018). Public health consequences of e-cigarettes. The National Academies Press.
• National Center for Chronic Disease Prevention and Health Promotion (US) Office on Smoking and Health. (2014). Patterns of tobacco use among U.S. youth, young adults, and adults. The Health Consequences of Smoking-50 Years of Progress: A Report of the Su
• National Substance Use and Mental Health Services Survey (N-SUMHSS) release (2022). SAMHSA.gov. (2022).
• Substance Abuse and Mental Health Services Administration. (2023). Mental Health for Young Adults.
• U.S. Department of Health and Human Services. (2023). Do people with mental illness and substance use disorders use tobacco more often?. National Institutes of Health.
• U.S. initiatives. Campaign for Tobacco-Free Kids. (2025).
• World Health Organization. (2023 a). Tobacco fact sheet. World Health Organization.

MeSH Terms

Conditions

Tobacco Use Disorder; Cigarette Smoking; Myopathies, Structural, Congenital

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Tobacco Smoking; Smoking; Behavior; Tobacco Use; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases

Central Study Contacts

Timothy Grigsby, PhD

CONTACT

(702) 895-4670; timothy.grigsby@unlv.edu

Refat Rasul Srejon, MBBS, MPH

CONTACT

5752499742; srejon@unlv.nevada.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This study is a two-arm randomized controlled trial (RCT) designed to evaluate the effectiveness of a smoking cessation intervention based on the Multi-Theory Model (MTM) among young adults aged 18-29. Participants are randomly assigned to either the MTM-based intervention group or a control group receiving knowledge based intervention. The intervention is delivered exclusively online to optimize accessibility, participant engagement, and scalability. The MTM framework guides behavior change strategies focused on both initiation and maintenance of smoking cessation. Outcomes are measured at baseline, immediately post-intervention, and at 12-week follow-up to assess efficacy and sustainability of quitting behaviors. Individual-level randomization minimizes contamination between groups and strengthens internal validity by ensuring balanced allocation of participants across intervention and control arms.

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 5, 2025
• Study Start: November 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: March 1, 2026
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: June 2026, for 3 years
• Access Criteria: Qualified researchers affiliated with academic institutions or public health organizations may request access to these de-identified, aggregate-level data and supporting materials such as study protocols, data dictionaries, and analysis plans. Access will be granted for non-commercial, scholarly research following submission of a formal proposal outlining study aims and analysis plans. Approval from the principal investigator and the institutional review board (IRB) may be required. Upon approval, data will be shared via a secure platform or encrypted file transfer to maintain confidentiality and data integrity. All recipients must sign a data use agreement prohibiting any attempt to re-identify participants or redistribute the data.

Locations

US (1)