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

Conditions

• Tobacco Use Disorder/Cigarette Smoking

Eligibility Criteria

Sex

ALL

Age

18 Years - 29 Years

Healthy Volunteers

Not accepted

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.

Study Details

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.

Key Dates

Start date

Nov 1, 2025

Status verified

Aug 2025

Primary completion

Dec 31, 2025

Completion

Mar 1, 2026

Study Design

Enrollment

144 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Active Comparator: Knowledge-Based Smoking Risk Education and Quit Strategies
  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.
• Experimental: Multi-Theory Model-Based Smoking Cessation Intervention
  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.

Primary Outcome Measure

Fagerström Test for Nicotine Dependence (FTND) measure [ Time Frame: Baseline to 12 week followup ]

Central Contacts

• Timothy Grigsby, PhD
  (702) 895-4670
  [email protected]
• Refat Rasul Srejon, MBBS, MPH
  5752499742
  [email protected]

Locations (1)

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