NCT01982825

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2013

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 3, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
5 months until next milestone

First Posted

Study publicly available on registry

November 13, 2013

Completed
Last Updated

December 5, 2013

Status Verified

December 1, 2013

Enrollment Period

6 months

First QC Date

January 3, 2013

Last Update Submit

December 3, 2013

Conditions

Keywords

Tobacco use cessationCigarette smoking

Outcome Measures

Primary Outcomes (1)

  • Intervention acceptability

    We will assess the acceptability of the intervention (i.e., reported satisfaction and engagement with the intervention).

    Week 6

Secondary Outcomes (3)

  • Cessation

    Week 6, Week 12

  • Cigarette consumption

    Week 6, Week 12

  • Quit Attempts

    Week 6, Week 12

Study Arms (2)

Online intervention arm

EXPERIMENTAL

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.

Behavioral: Online intervention arm

Online control arm

ACTIVE COMPARATOR

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.

Behavioral: Online control arm

Interventions

See online intervention arm

Online intervention arm

See online control arm

Online control arm

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age ≥ 18 and less than 30,
  • enrolled at least part-time,
  • intending to be in one of the two participating schools (Georgia State University, Valdosta State University) for the academic year,
  • able to read English, and
  • any cigarette smoking in previous 30 days.

You may not qualify if:

  • Significant mental health problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Tobacco Use CessationCigarette Smoking

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorTobacco SmokingSmokingTobacco Use

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 3, 2013

First Posted

November 13, 2013

Study Start

January 1, 2013

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

December 5, 2013

Record last verified: 2013-12

Locations