Tailored Web and Peer Email Cessation Counseling for College Smokers (RealU)

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

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.

Study Overview

• Status: Completed
• Conditions: Cigarette Smoking
• Intervention / Treatment: Other: Untailored Web; Behavioral: Tailored Web; Behavioral: Peer Coaching

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.

• Study Type: Interventional
• Enrollment (Actual): 1699
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: May 21, 2012
• First Submitted That Met QC Criteria: May 21, 2012
• First Posted (Estimate): May 23, 2012

Study Record Updates

• Last Update Posted (Estimate): May 23, 2012
• Last Update Submitted That Met QC Criteria: May 21, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: R01HL089491 (U.S. NIH Grant/Contract)