Innovative Web-Based Intervention for Smoking Cessation Among College Students

NCT ID: NCT01982825

Last Updated: 2013-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2013-07-31

Brief 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.

Detailed 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).

Conditions

Tobacco Use Cessation; Cigarette Smoking

Keywords

Tobacco use cessation; Cigarette smoking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Online intervention arm

Bi-weekly (MTh) for 6 weeks, participants will receive an email asking them to report number of cigarettes smoked, alcoholic drinks, engagement in physical activity, and overall mood the two-three days before. Upon answering, they will be launched to the site which will contain health messaging focused on smoking and other health topics.

Group Type: EXPERIMENTAL

Online intervention arm

Intervention Type: BEHAVIORAL

See online intervention arm

Online control arm

Control participants will receive bi-weekly emails (MTh) over 6 weeks but in the context of a standard smoking cessation website. Because we are primarily testing the check-ins, tailored feedback, and market research-based mini-drama and other web content, we feel that this control group will isolate the hypothesized active elements of our program.

Group Type: ACTIVE_COMPARATOR

Online control arm

Intervention Type: BEHAVIORAL

See online control arm

Interventions

Online intervention arm

See online intervention arm

Intervention Type: BEHAVIORAL

Online control arm

See online control arm

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Georgia State University

OTHER

Sponsor Role: collaborator

Valdosta State University

OTHER

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Carla Berg

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Emory University

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

1R43TR000358-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00059657

Identifier Type: -

Identifier Source: org_study_id