Smoking CessationNCT02730260
Worksite Phone Counseling for Smoking Cessation
A study testing Nondirective smoking cessation coaching and Directive smoking cessation coaching in people with Smoking Cessation, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Nondirective smoking cessation coaching and Directive smoking cessation coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 518 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2005to Sep 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Smoking employee or spouse in contemplation, action, or recently entering maintenance stage of change
- English speaking
Who cannot join
- Smoker in precontemplation stage of change
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
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.
Read the 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
- Being tested
- Nondirective smoking cessation coaching, Directive smoking cessation coaching
- Keywords
- Directive coaching, Nondirective coaching, smoking cessation quitline, social support
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nondirective smoking cessation coachingBehavioural
Quitline coach allows participant to set agenda for each call.
Directive smoking cessation coachingBehavioural
Quitline coach follows a pre-specified agenda for each call, and does not allow participant to deviate from the agenda.
| Study group | Role | What they receive |
|---|---|---|
| Directive | Active comparator | Participants receive up to 7 directive smoking cessation coaching telephone calls from the quitline over 9 weeks. Receives: Behavioral: Directive smoking cessation coaching |
| Nondirective | Experimental | Participants receive up to 7 nondirective smoking cessation coaching telephone calls from the quitline over 9 weeks. Receives: Behavioral: Nondirective smoking cessation coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2016 (estimated)
- Study startFeb 2005
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 518 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Walton Sumner, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02730260
- Sponsor's protocol ID
- 04-1335
- Status last verified
- Oct 2016
- First submitted
- 31 Mar 2016
- Last updated
- 23 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Researchers interested in using individual participant data may contact the PI. Only de-identified baseline, 6 month, and 12 month data will be available.
Publications
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.
PubMed 39868569Sumner 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.
PubMed 27400966
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Worksite Phone Counseling for Smoking Cessation
- ClinicalTrials.gov ID
- NCT02730260
- Acronym / sponsor ID
- 04-1335
- Conditions
- Smoking Cessation
- Keywords
- Directive coaching, Nondirective coaching, smoking cessation quitline, social support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 518 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Feb 2005
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 6 Apr 2016 (estimated)
- Results
- Posted 23 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Directive | Active comparator | Behavioral: Directive smoking cessation coachingParticipants receive up to 7 directive smoking cessation coaching telephone calls from the quitline over 9 weeks. |
| Nondirective | Experimental | Behavioral: Nondirective smoking cessation coachingParticipants receive up to 7 nondirective smoking cessation coaching telephone calls from the quitline over 9 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Smoking employee or spouse in contemplation, action, or recently entering maintenance stage of change
- English speaking
Key exclusion criteria (1 listed)
- Smoker in precontemplation stage of change
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nondirective smoking cessation coachingQuitline coach allows participant to set agenda for each call. | Behavioural | Nondirective |
| Directive smoking cessation coachingQuitline coach follows a pre-specified agenda for each call, and does not allow participant to deviate from the agenda. | Behavioural | Directive |
Primary outcome
Smoking Abstinence for 7 Days at Last Contact
Time frame: 6-12 months
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39868569Theodoulou 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.
- Derived from this study: PubMed 27400966Sumner 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.
- Individual participant dataSharing planned: Yes. Researchers interested in using individual participant data may contact the PI. Only de-identified baseline, 6 month, and 12 month data will be available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Walton Sumner, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nondirective smoking cessation coaching and Directive smoking cessation coaching in people with Smoking Cessation, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking Abstinence for 7 Days at Last Contact (time frame: 6-12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02730260, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2016.