Tailored Web and Peer Email Cessation Counseling for College Smokers

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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RealU: Tailored Web and Peer Email Cessation Counseling for College Smokers

Conditions
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Cigarette Smoking

Intervention / Treatment
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* Behavioral: Tailored Web
* Behavioral: Peer Coaching
* Other: Untailored Web


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Control<br>Participants randomized to this group received access to an untailored general interest/lifestyle website. | Other: Untailored Web<br>* 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.<br>|
| Experimental: Tailored Health and Lifestyle Web<br>Participants randomized to this arm received tailored web content about health and wellness, with weekly goal-setting and feedback. | Behavioral: Tailored Web<br>* 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.<br>|
| Experimental: Tailored Web plus Peer Coaching<br>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<br>* 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.<br>Behavioral: Peer Coaching<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported 30-day abstinence at Week 12 | 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. | 12 weeks post-enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self reported 7-day abstinence at 7 weeks | Participants were asked to select which of the days in the past 7 (Sun-Sat) they had smoked even one puff. | 7-weeks post-enrollment | 
| Self-reported 7-day abstinence at Week 12 | Participants were asked to select which days in the past 7 (Sun-Sat) they had smoked at least one puff. | 12-weeks post-enrollment |