Cigarette SmokingRealUNCT01604525
Tailored Web and Peer Email Cessation Counseling for College Smokers
A study testing Tailored Web, Peer Coaching and Untailored Web in people with Cigarette Smoking, run by University of Michigan.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking
- What is being tested?
- Tailored Web, Peer Coaching and Untailored Web
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,699 participants
- Where
- No sites listed yet
- Study dates
- May 2011to Nov 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Use of smokeless tobacco in the past 30 days
About this study
Official title: 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.
Read the 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.
- Conditions
- Cigarette Smoking
- Being tested
- Tailored Web, Peer Coaching, Untailored Web
- Medical subject headings
- Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored WebBehavioural
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 CoachingBehavioural
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.
Untailored WebOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Sham comparator | Participants randomized to this group received access to an untailored general interest/lifestyle website. Receives: Other: Untailored Web |
| Tailored Health and Lifestyle Web | Experimental | Participants randomized to this arm received tailored web content about health and wellness, with weekly goal-setting and feedback. Receives: Behavioral: Tailored Web |
| Tailored Web plus Peer Coaching | Experimental | 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). Receives: Behavioral: Tailored Web; Behavioral: Peer Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks post-enrollment
Secondary outcomes (2)
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.
Measured: 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.
Measured: 12-weeks post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2012 (estimated)
- Study startMay 2011
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cigarette SmokingStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,699 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Lawrence C. An, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01604525
- Sponsor's protocol ID
- R01HL089491
- Acronym
- RealU
- Status last verified
- May 2012
- First submitted
- 21 May 2012
- Last updated
- 23 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RealU: Tailored Web and Peer Email Cessation Counseling for College Smokers
- ClinicalTrials.gov ID
- NCT01604525
- Acronym / sponsor ID
- RealU / R01HL089491
- Conditions
- Cigarette Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,699 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- May 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 23 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Sham comparator | Other: Untailored WebParticipants randomized to this group received access to an untailored general interest/lifestyle website. |
| Tailored Health and Lifestyle Web | Experimental | Behavioral: Tailored WebParticipants randomized to this arm received tailored web content about health and wellness, with weekly goal-setting and feedback. |
| Tailored Web plus Peer Coaching | Experimental | Behavioral: Tailored Web, Behavioral: Peer CoachingParticipants 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). |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Use of smokeless tobacco in the past 30 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tailored WebThe 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. | Behavioural | Tailored Health and Lifestyle Web, Tailored Web plus Peer Coaching |
| Peer CoachingParticipants 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. | Behavioural | Tailored Web plus Peer Coaching |
| Untailored WebContent 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. | Other | Control |
Primary outcome
Self-reported 30-day abstinence at Week 12
Time frame: 12 weeks post-enrollment
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.
2 secondary outcomes
Self reported 7-day abstinence at 7 weeks
Time frame: 7-weeks post-enrollment
Self-reported 7-day abstinence at Week 12
Time frame: 12-weeks post-enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored Web, Peer Coaching and Untailored Web in people with Cigarette Smoking, run by University of Michigan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported 30-day abstinence at Week 12 (time frame: 12 weeks post-enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2012.