NCT02730260

Brief Summary

Social support is poorly understood but likely to influence outcomes of behavior change efforts. Social support may take a directive or nondirective approach. In directive support, the person attempting a behavior change is told what to do and even what to think. In nondirective support, the person attempting the behavior change decides what to discuss. In some contexts, interactions of race or income with social support have been reported. This is a randomized controlled trial of directive and nondirective coaching in the context of a smoking quitline offered to employees of two large corporations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
518

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2005

Longer than P75 for not_applicable

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, 2005

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
7.6 years until next milestone

First Submitted

Initial submission to the registry

March 31, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 6, 2016

Completed
9 months until next milestone

Results Posted

Study results publicly available

December 23, 2016

Completed
Last Updated

December 23, 2016

Status Verified

October 1, 2016

Enrollment Period

3.6 years

First QC Date

March 31, 2016

Results QC Date

June 1, 2016

Last Update Submit

October 31, 2016

Conditions

Smoking Cessation

Keywords

Directive coachingNondirective coachingsmoking cessation quitlinesocial support

Outcome Measures

Primary Outcomes (1)

  • Smoking Abstinence for 7 Days at Last Contact

    By self report, the participant has smoked no cigarettes in the past 7 days on the date of last post-intervention assessment, which occurs 6 to 12 months after enrollment.

    6-12 months

Study Arms (2)

Directive

ACTIVE COMPARATOR

Participants receive up to 7 directive smoking cessation coaching telephone calls from the quitline over 9 weeks.

Behavioral: Directive smoking cessation coaching

Nondirective

EXPERIMENTAL

Participants receive up to 7 nondirective smoking cessation coaching telephone calls from the quitline over 9 weeks.

Behavioral: Nondirective smoking cessation coaching

Interventions

Nondirective smoking cessation coachingBEHAVIORAL

Quitline coach allows participant to set agenda for each call.

Nondirective
Directive smoking cessation coachingBEHAVIORAL

Quitline coach follows a pre-specified agenda for each call, and does not allow participant to deviate from the agenda.

Directive

Eligibility Criteria

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

You may qualify if:

  • Smoking employee or spouse in contemplation, action, or recently entering maintenance stage of change
  • English speaking

You may not qualify if:

  • Smoker in precontemplation stage of change

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (2)

  • Theodoulou A, Fanshawe TR, Leavens E, Theodoulou E, Wu AD, Heath L, Stewart C, Nollen N, Ahluwalia JS, Butler AR, Hajizadeh A, Thomas J, Lindson N, Hartmann-Boyce J. Differences in the effectiveness of individual-level smoking cessation interventions by socioeconomic status. Cochrane Database Syst Rev. 2025 Jan 27;1(1):CD015120. doi: 10.1002/14651858.CD015120.pub2.

    PMID: 39868569DERIVED

  • Sumner W 2nd, Walker MS, Highstein GR, Fischer I, Yan Y, McQueen A, Fisher EB. A randomized controlled trial of directive and nondirective smoking cessation coaching through an employee quitline. BMC Public Health. 2016 Jul 11;16:550. doi: 10.1186/s12889-016-3202-y.

    PMID: 27400966DERIVED

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Results Point of Contact

Title
Dr. Walton Sumner
Organization
Washington University School of Medicine
wsumner@dom.wustl.edu
314-454-8164

Study Officials

  • Walton Sumner, MD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2016

First Posted

April 6, 2016

Study Start

February 1, 2005

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

December 23, 2016

Results First Posted

December 23, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will share

Researchers interested in using individual participant data may contact the PI. Only de-identified baseline, 6 month, and 12 month data will be available.

Locations

US(1)