NCT02602730

Brief Summary

This project developed and evaluated an Internet-based interactive program with digital coaching designed to assist two groups of smokers in quitting smoking: (1) pregnant smokers and (2) general-population smokers (i.e., men and non-pregnant women). Program content was based on the U.S. Department of Health and Human Services Clinical Practice Guidelines, "Treating Tobacco Use and Dependence: 2008 Update" (Fiore et al., 2008) and input from project consultants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
307

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

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, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 2, 2015

Completed
10 months until next milestone

First Posted

Study publicly available on registry

November 11, 2015

Completed
Last Updated

November 11, 2015

Status Verified

November 1, 2015

Enrollment Period

1.5 years

First QC Date

January 2, 2015

Last Update Submit

November 10, 2015

Conditions

Cigarette SmokingSmoking, Tobacco

Keywords

Cigarette smokingSmoking, Tobaccopostpartuminternetinteractivecoach

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in number of cigarettes smoked in the last 7 days

    Smoking cessation as measured by number of cigarettes smoked in the last 7 days. We will use an intent-to-treat statistical analysis, a conservative approach that classifies all non-responders as smokers.

    10 months

Secondary Outcomes (6)

  • Change from baseline in knowledge of impact of smoking cessation

    10 months

  • Change from baseline in self-efficacy to quit smoking

    10 months

  • Change from baseline in attitudes about smoking cessation

    10 months

  • Change from baseline in behavioral intentions about smoking cessation

    10 months

  • Program satisfaction

    4-week posttest

  • +1 more secondary outcomes

Study Arms (2)

Break the Chain

EXPERIMENTAL

Access during the evaluation study period to an Internet smoking cessation intervention that included digital coaching messages sent at prescribed times during the participant's quit process and as needed in response to participant questions or comments.

Behavioral: Break the Chain

Clearing the Air PDF

ACTIVE COMPARATOR

Control users were e-mailed a copy of the National Cancer Institute's PDF smoking cessation booklet, "Clearing the Air."

Behavioral: Clearing the Air

Interventions

Break the ChainBEHAVIORAL

Internet-based smoking cessation intervention designed for general population smokers with targeted materials for pregnant women. The program included a digital coaching component delivered via email at specific points as the user progresses through his/her quit process. Program content is based on Department of Health and Human Services Clinical Practice Guidelines for Treating Tobacco Use and Dependence.

Break the Chain
Clearing the AirBEHAVIORAL

PDF version of smoking cessation booklet from National Cancer Institute.

Clearing the Air PDF

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • Between 8 and 32 weeks pregnant
  • Currently smoking, trying to quit, or quit smoking within last 2 months
  • Able to speak and read English
  • Have access to high-speed or DSL Internet and email for the duration of the study.
  • Male or female not pregnant
  • years or older
  • Currently smoking, trying to quit, or quit smoking within last 2 months
  • Able to speak and read English
  • Have access to high-speed or DSL Internet and email for the duration of the study
  • Men and women under age 18 were excluded.
  • Women who were pregnant but whose pregnancy did not fit within the specified time frame were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Center for Applied Science

Eugene, Oregon, 97401, United States

Location

MeSH Terms

Conditions

Cigarette SmokingTobacco Smoking

Condition Hierarchy (Ancestors)

SmokingBehaviorTobacco Use

Study Officials

  • Susan W Schroeder, MPH, MCHES

    Oregon Center for Applied Science

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist

Study Record Dates

First Submitted

January 2, 2015

First Posted

November 11, 2015

Study Start

February 1, 2012

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

November 11, 2015

Record last verified: 2015-11

Locations

US(1)