NCT01604525

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,699

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2011

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 23, 2012

Completed
Last Updated

May 23, 2012

Status Verified

May 1, 2012

Enrollment Period

6 months

First QC Date

May 21, 2012

Last Update Submit

May 21, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Self reported 7-day abstinence at 7 weeks

    7-weeks post-enrollment

  • Self-reported 7-day abstinence at Week 12

    12-weeks post-enrollment

Study Arms (3)

Control

SHAM COMPARATOR

Participants randomized to this group received access to an untailored general interest/lifestyle website.

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.

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).

Behavioral: Tailored WebBehavioral: Peer Coaching

Interventions

Tailored WebBEHAVIORAL

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.

Tailored Health and Lifestyle WebTailored Web plus Peer Coaching
Peer CoachingBEHAVIORAL

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.

Tailored Web plus Peer Coaching

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.

Control

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Use of smokeless tobacco in the past 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cigarette Smoking

Condition Hierarchy (Ancestors)

Tobacco SmokingSmokingBehaviorTobacco Use

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Internal Medicine, Medical School

Study Record Dates

First Submitted

May 21, 2012

First Posted

May 23, 2012

Study Start

May 1, 2011

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

May 23, 2012

Record last verified: 2012-05