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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Lawrence C. An, University of Michigan
ClinicalTrials.gov Identifier:
NCT01604525
First received: May 21, 2012
Last updated: NA
Last verified: May 2012
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  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

ClinicalTrials.gov processed this record on August 20, 2014