Worksite Phone Counseling for Smoking Cessation

NCT ID: NCT02730260

Last Updated: 2016-12-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 518 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-02-28
• Study Completion Date: 2008-09-30

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.

Detailed Description

BACKGROUND Given the association of smoking with low socioeconomic status, the potential of telephone counseling for smoking cessation to reach diverse audiences needs evaluation. In addition, different approaches to counseling have not been systematically examined, and may differentially affect reach, retention, and success.

PURPOSE To describe employee participation and outcomes in a trial of two counseling styles for telephone-based smoking cessation support.

APPROACH Employees and spouses of two large organizations are invited to participate in a trial of a telephone quitline. Participants are randomized to one of two coaching styles. A protocol-driven (Directive) coaching approach follows a script for each of seven calls over 9 weeks. A participant-centered (Nondirective) coaching approach allowed smokers to select topics of interest, with prompting by the coach as needed. A computer assisted telephone interview program and database provide topics in correct sequence for directive coaching, allow coaches to indicate topics during nondirective coaching, and track time spent on topics in both conditions.

PREDICTOR VARIABLES Demographics, smoking history and conventional self-reported measures of nicotine dependence, smoking urges, preference for patient-centric care, and depression are collected at baseline.

OUTCOMES The primary outcome measure is self-reported abstinence from smoking for 7 days at the time of last follow up, 6 or 12 months after baseline assessment.

ANALYSES Interactions of Race and Income with coaching approach are analyzed. Based on results with asthma patients, a positive interaction of low income with nondirective coaching is tested.

Conditions

Smoking Cessation

Keywords

Directive coaching; Nondirective coaching; smoking cessation quitline; social support

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Directive

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

Group Type: ACTIVE_COMPARATOR

Directive smoking cessation coaching

Intervention Type: BEHAVIORAL

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

Nondirective

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

Group Type: EXPERIMENTAL

Nondirective smoking cessation coaching

Intervention Type: BEHAVIORAL

Quitline coach allows participant to set agenda for each call.

Interventions

Nondirective smoking cessation coaching

Quitline coach allows participant to set agenda for each call.

Intervention Type: BEHAVIORAL

Directive smoking cessation coaching

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Smoker in precontemplation stage of change

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Walton Sumner, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 39868569 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27400966 (View on PubMed)

Other Identifiers

04-1335

Identifier Type: -

Identifier Source: org_study_id