Tailored Web and Peer Email Cessation Counseling for College Smokers

Cigarette Smoking Clinical Trial

— RealU  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01604525
• Other study ID #: R01HL089491
• Status: Completed
• Phase: N/A
• First received: May 21, 2012
• Last updated: May 21, 2012
• Start date: May 2011
• Est. completion date: November 2011

Study information

• Verified date: May 2012
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1699
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cigarette Smoking

Intervention

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.
• 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.

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Heart, Lung, and Blood Institute (NHLBI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No