NCT02329249

Brief Summary

There is an important need for effective smoking cessation programs that both (a) promote the effective use of pharmacological aids, such as nicotine replacement products and bupropion, and (b) provide cognitive-behavioral support for stopping smoking.The Internet is an increasingly attractive intervention medium for delivering behavior change interventions, including smoking cessation.This study examined smoking cessation rates among adults participating in a randomized controlled trial of the Smokefree Partners: 21 Days to Freedom ™ program, a theoretically based, online smoking cessation program that included message tailoring and interactivity combined with the live personal support of a smoking cessation coach. Coaching support was provided almost entirely asynchronously via prescripted but individually tailored emails.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2001

Longer than P75 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

February 1, 2001

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
9 years until next milestone

First Submitted

Initial submission to the registry

December 29, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 31, 2014

Completed
Last Updated

January 1, 2015

Status Verified

December 1, 2014

Enrollment Period

3.9 years

First QC Date

December 29, 2014

Last Update Submit

December 31, 2014

Conditions

Smoking Cessation

Keywords

smoking cessationcoach-supportedtobacco use cessationonlineinternet-basedtailored

Outcome Measures

Primary Outcomes (1)

  • Smoking cessation

    Current smoking status was determined with two items: (a) a stage of change measure indicating smoking status and (b) a measure indicating the number of cigarettes smoked in the past 7 days. Abstinence at 30-day posttest and 120-day follow-up was confirmed by the participant choosing both (a) the response of "I do not currently smoke; I quit in the last 6 months" to the stage of change measure and (b) a response of "0" to the question "During the past 7 days, how many cigarettes did you smoke each day?"

    120 days

Secondary Outcomes (4)

  • Intentions to quit smoking

    30 days and 120 days after baseline

  • intentions to quit and remain smokefree

    30 days and 120 days after baseline

  • self-efficacy for quitting

    30 days and 120 days after baseline

  • intentions to use a pharmacological smoking cessation aid (PA)

    30 days and 120 days after baseline

Study Arms (2)

Smokefree Partners: 21 Days to Freedom

EXPERIMENTAL

Smoking cessation website program with live personal coach

Behavioral: Smokefree Partners: 21 Days to Freedom

Wait-list control

OTHER

120-day wait-list and then provided access to the smoking cessation website

Other: Wait-List Control

Interventions

Smokefree Partners: 21 Days to FreedomBEHAVIORAL

Treatment subjects, who chose a quit date, were given 21 sessions to be viewed one session (i..e, one day) at a time, and an in-person smoking cessation coach to support them through their quit process via tailored email or phone coaching messages. Treatment users were encouraged to use pharmacological aids in their quit attempt, but smoking cessation aids were not provided.

Also known as: Pharmacological Aids for Interactive Smoking Cessation
Smokefree Partners: 21 Days to Freedom
Wait-List ControlOTHER

Subjects randomized to the control condition were placed on a wait-list and given access to the smoking cessation program after 120 days and completion of the 120-day follow-up assessment.

Wait-list control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • large worksites with internet connection
  • thinking of quitting smoking
  • years of age or older

You may not qualify if:

  • not thinking of quitting smoking
  • years of age or younger

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Smoking CessationTobacco Use Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Susan Schroeder, MPH, MCHES

    Oregon Center for Applied Science

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist

Study Record Dates

First Submitted

December 29, 2014

First Posted

December 31, 2014

Study Start

February 1, 2001

Primary Completion

January 1, 2005

Study Completion

January 1, 2006

Last Updated

January 1, 2015

Record last verified: 2014-12