Tailored Web and Peer Email Cessation Counseling for College Smokers (RealU)
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Purpose
The RealU2 is a randomized controlled trial to determine the efficacy of an online health and wellness program for young adults with the addition of individualized peer health coaching.
| Condition | Intervention |
|---|---|
|
Cigarette Smoking |
Behavioral: Tailored Web Behavioral: Peer Coaching Other: Untailored Web |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | RealU: Tailored Web and Peer Email Cessation Counseling for College Smokers |
- Self-reported 30-day abstinence at Week 12 [ Time Frame: 12 weeks post-enrollment ] [ Designated as safety issue: No ]Participants were asked how many days they had smoked in the past 30 days during the follow-up survey conducted 12-13 weeks post-enrollment.
- Self reported 7-day abstinence at 7 weeks [ Time Frame: 7-weeks post-enrollment ] [ Designated as safety issue: No ]Participants were asked to select which of the days in the past 7 (Sun-Sat) they had smoked even one puff.
- Self-reported 7-day abstinence at Week 12 [ Time Frame: 12-weeks post-enrollment ] [ Designated as safety issue: No ]Participants were asked to select which days in the past 7 (Sun-Sat) they had smoked at least one puff.
| Enrollment: | 1699 |
| Study Start Date: | May 2011 |
| Study Completion Date: | November 2011 |
| Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Sham Comparator: Control
Participants randomized to this group received access to an untailored general interest/lifestyle website.
|
Other: Untailored Web
Content about lifestyle issues (music, travel, dating) was created for participants assigned to the control group. There was new web content each week for 6 weeks.
|
|
Experimental: Tailored Health and Lifestyle Web
Participants randomized to this arm received tailored web content about health and wellness, with weekly goal-setting and feedback.
|
Behavioral: Tailored Web
The tailored website included 6 weeks of content about making healthy lifestyle choices, eating breakfast, exercising, reducing drinking and quitting smoking. Each week, participants were asked to check in with their past week's behavior, and to set goals for the next week's check-in.
|
|
Experimental: Tailored Web plus Peer Coaching
Participants randomized to this arm received access to weekly tailored health and wellness web content, plus weekly feedback from a peer health coach (videos uploaded to the web and phone calls).
|
Behavioral: Tailored Web
The tailored website included 6 weeks of content about making healthy lifestyle choices, eating breakfast, exercising, reducing drinking and quitting smoking. Each week, participants were asked to check in with their past week's behavior, and to set goals for the next week's check-in.
Behavioral: Peer Coaching
Participants chose a peer coach, who reviewed the participant's check-in data and goals, and provided personalized feedback to help the participant reach those goals. Interaction took place via personalized videos recorded each week and uploaded to a participant's web profile, and through pro-active phone calls to the participants each week.
|
Detailed Description:
The RealU addresses smoking in a young adult population of occasional and daily smokers.
Aim 1. To determine the efficacy of providing individually tailored smoking cessation messages as part of a general interest website for young adults.
Aim 2. To determine the efficacy of providing individually tailored smoking cessation messages plus peer email, phone and online support as part of a general interest website for young adults.
Participants were recruited via direct emails sent to undergraduate and graduate students at the University of MI as well as direct emails sent to participants from Survey Sampling International and National Data Group. Individuals were invited to complete an online survey about health and hope in young adults. Participants eligible for the full intervention were invited to join the RealU Study.
Participants were asked to complete an online enrollment survey and consent form. Eligible, enrolled participants were randomly assigned to one of the following three study arms:
- an untailored general interest/lifestyle website
- an individually tailored web intervention about health and lifestyle
- an individually tailored web intervention about health and lifestyle with coaching from peers, including video, phone, and email
Assessments were conducted at 7 weeks and 12 weeks post-enrollment. The primary outcome measure is self-reported 30-day abstinence at 12 weeks.
Eligibility| Ages Eligible for Study: | 18 Years to 35 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Age 18-35
- Able to read English
- Internet access for the next 3 months
- Self-reported internet use of more than once per week
- Smoked at least one puff of a cigarette in the past 30 days
Exclusion Criteria:
- Use of smokeless tobacco in the past 30 days
Contacts and Locations More Information
No publications provided
| Responsible Party: | Lawrence C. An, Associate Professor of Internal Medicine, Medical School, University of Michigan |
| ClinicalTrials.gov Identifier: | NCT01604525 History of Changes |
| Other Study ID Numbers: | R01 HL089491 |
| Study First Received: | May 21, 2012 |
| Last Updated: | May 21, 2012 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Smoking Habits |
ClinicalTrials.gov processed this record on May 16, 2013