Innovative Web-Based Intervention for Smoking Cessation Among College Students

Cigarette Smoking Clinical Trial

Official title:

Innovative Web-Based Intervention for Smoking Cessation Among College Students

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01982825
• Other study ID #: IRB00059657
• Secondary ID: 1R43TR000358-01
• Status: Completed
• Phase: Phase 1
• First received: January 3, 2013
• Last updated: December 3, 2013
• Start date: January 2013
• Est. completion date: July 2013

Study information

• Verified date: December 2013
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Emory University Institutional Review BoardUnited States: Emory Office of Clinical ResearchUnited States: Georgia State University Institutional Review BoardUnited States: Emory University Office of Research ComplianceUnited States: National Institutes of Health
• Study type: Interventional

Clinical Trial Summary

Tobacco use is the leading cause of cancer death in the U.S. Because smokers who quit by age 30 have cancer death risk similar to non-smokers, promoting cessation early in life is critical. U.S. colleges/universities, enrolling >14 million students/year (40% of those aged 18 to 24), are an important venue to reach young adult smokers. While daily tobacco use in the U.S. has declined to 18.1%, nondaily smoking (smoking on some days but not every day) is increasing, particularly among young adults and African Americans. Moreover, young smokers and nondaily smokers (half of young adult smokers), respectively, are less likely to seek help in quitting; thus, innovative strategies are needed to assist cessation early in life, particularly among those who may not be motivated to quit or seek help. Unfortunately, no research has focused on developing a cessation intervention that addresses a broad range of smoking patterns (nondaily to daily smoking) or diverse campus settings among ethnically diverse student populations. Web-based interventions offer promise in helping college students to quit, given high rates of Internet use and web capacity to provide tailored cessation messages. A novel approach to delivering cessation information via the web might be to address broader lifestyle issues and apply market research strategies to identify market segments of smokers (groups of people with similar interests, goals, values) in order to target and engage these groups more effectively. Applying this strategy to an online cessation intervention should enhance both intervention use and processing of intervention messages, leading to greater abstinence rates. The investigators aim to: (1) develop and refine a tailored web-based intervention for smoking cessation targeting college students with a range of smoking levels; (2) test the usability, acceptability, and feasibility of the intervention among college student smokers; and (3) determine the potential effect of the intervention on smoking cessation, smoking level, quit attempts, and contextual factors.

Description:

Tobacco use is the leading cause of cancer death. Because smokers who quit by 30 have cancer death risk similar to non-smokers, promoting cessation early in life is critical. U.S. colleges/universities, enrolling >14 million students/year (40% of those aged 18 to 24), are an important venue to reach young adult smokers. While daily tobacco use in the U.S. has declined to 18.1%, nondaily smoking (smoking on some days but not every day) is increasing, particularly among young adults and African Americans. Moreover, young smokers and nondaily smokers (half of young adult smokers9), respectively, are less likely to seek help in quitting; thus, innovative strategies are needed to assist cessation early in life, particularly among those who may not be motivated to quit or seek help. Unfortunately, no research has focused on developing a cessation intervention that addresses a broad range of smoking patterns (nondaily to daily smoking) or diverse campus settings among ethnically diverse student populations. Web-based interventions offer promise in helping college students to quit, given high rates of Internet use and web capacity to provide tailored cessation messages. A novel approach to delivering cessation information might be to address broader lifestyle issues and apply market research strategies such as those used by the tobacco industry to identify market segments of smokers (groups of people with similar interests, goals, values) in order to target and engage these groups more effectively. Applying this strategy to an online cessation intervention should enhance both intervention use and processing of intervention messages, leading to greater abstinence rates.

Our specific aims are:

• Aim 1: To develop and refine a tailored web-based intervention for smoking cessation targeting young adults representing a range of sociodemographic backgrounds, particularly including those from low SES and African American backgrounds, and a range of smoking levels (i.e., nondaily, low-level smokers to daily, heavy smokers) attending college.

• Aim 2: To test the usability, acceptability, and feasibility of the intervention among a sample of college student smokers.

• Aim 3: To determine the potential effect of the intervention on smoking cessation, smoking level, quit attempts, and contextual factors (e.g., mood, alcohol use, social factors) among a sample of college student smokers from various backgrounds and smoking patterns.

This research will be addressed through three phases. Phase 1 will involve the development of the web-site infrastructure, securing incentives, developing website content (dramas, stories), and developing the tailored feedback infrastructure. Phase 2 will involve expert feedback, which will be integrated into the next program version. Phase 3 involves a 6-week trial among a small sample of young adults at two college campuses (university; community/technical college) in Georgia (N = 200). At end-of-intervention, we will assess usability, acceptability, and feasibility of the program; smoking status and level; and psychosocial factors related to smoking (e.g. alcohol use, mood). Assessments of smoking status/level and psychosocial factors will also be conducted at 6 weeks post-intervention. The primary outcomes in the trial are usability, acceptability, and feasibility (self-reported and observed website utilization [check-in, activity]). Secondary outcomes include: (1) message processing (self-reported attention to messages, perceived relevance, and other message use items);19 (2) 7-day and 30-day point prevalence abstinence at end-of-treatment (6 weeks) and at 6-week follow-up (12 weeks) in order to appropriately examine cessation among daily and nondaily smokers; (3) smoking level at 6 and 12 weeks; (4) number of quit attempts since baseline; and (5) change in other contextual factors (mood, alcohol use, social aspects).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

1. age = 18 and less than 30,

2. enrolled at least part-time,

3. intending to be in one of the two participating schools (Georgia State University, Valdosta State University) for the academic year,

4. able to read English, and

5. any cigarette smoking in previous 30 days.

Exclusion Criteria:

• Significant mental health problems.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cigarette Smoking
• Tobacco Use Cessation

Intervention

Behavioral:
• Online intervention arm
See online intervention arm
• Online control arm
See online control arm

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia

Sponsors (4)

Lead Sponsor	Collaborator
Emory University	Georgia State University, National Institutes of Health (NIH), Valdosta State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intervention acceptability	We will assess the acceptability of the intervention (i.e., reported satisfaction and engagement with the intervention).	Week 6	No
Secondary	Cessation	We will assess cessation (self-reported).	Week 6, Week 12	No
Secondary	Cigarette consumption	We will assess cigarette consumption to examine changes in consumption over time.	Week 6, Week 12	No
Secondary	Quit Attempts	We will assess quit attempts from baseline to follow up.	Week 6, Week 12	No