Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Directive | Active Comparator | Participants receive up to 7 directive smoking cessation coaching telephone calls from the quitline over 9 weeks. |
|
| Nondirective | Experimental | Participants receive up to 7 nondirective smoking cessation coaching telephone calls from the quitline over 9 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nondirective smoking cessation coaching | Behavioral | Quitline coach allows participant to set agenda for each call. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Walton Sumner, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39868569 | Derived | 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. | |
| 27400966 |
Not provided
Not provided
Researchers interested in using individual participant data may contact the PI. Only de-identified baseline, 6 month, and 12 month data will be available.
Not provided
Not provided
Not provided
Not provided
978 persons inquired about the program. 847 took steps to qualify for an employer health insurance discount Of these, 294 declined to enroll, e.g. for being in the precontemplative stage of change.
553 persons participated in coaching. Of these, 35 worked with coaches in training. 518 participants enrolled in the randomized trial.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Directive | Participants receive up to 7 directive smoking cessation coaching telephone calls from the quitline over 9 weeks. Directive smoking cessation coaching: Quitline coach follows a pre-specified agenda for each call, and does not allow participant to deviate from the agenda. |
| FG001 | Nondirective | Participants receive up to 7 nondirective smoking cessation coaching telephone calls from the quitline over 9 weeks. Nondirective smoking cessation coaching: Quitline coach allows participant to set agenda for each call. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Directive | Participants receive up to 7 directive smoking cessation coaching telephone calls from the quitline over 9 weeks. Directive smoking cessation coaching: Quitline coach follows a pre-specified agenda for each call, and does not allow participant to deviate from the agenda. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | These are participants who were successfully contacted at 6 or 12 months following enrollment. Other participants are counted as continuing smokers. | Posted | Number | participants | 6-12 months |
|
2 years, 5 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Directive | Participants receive up to 7 directive smoking cessation coaching telephone calls from the quitline over 9 weeks. Directive smoking cessation coaching: Quitline coach follows a pre-specified agenda for each call, and does not allow participant to deviate from the agenda. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Walton Sumner | Washington University School of Medicine | 314-454-8164 | wsumner@dom.wustl.edu |
Not provided
| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Directive smoking cessation coaching | Behavioral | Quitline coach follows a pre-specified agenda for each call, and does not allow participant to deviate from the agenda. |
|
| 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. |
| Nondirective |
Participants receive up to 7 nondirective smoking cessation coaching telephone calls from the quitline over 9 weeks. Nondirective smoking cessation coaching: Quitline coach allows participant to set agenda for each call. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Gender | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Income | Income levels are:
| Median | Inter-Quartile Range | units on a scale |
|
| Education | The education scale is:
| Median | Inter-Quartile Range | units on a scale |
|
| Fagerström Test for Nicotine Dependence (FTND) | Scores for 3 binary and 3 multiple choice items in the Fagerstrom Test for Nicotine Dependence are summed to yield a total score of 0-10. . Classification of dependence: 0-2 Very low; 3-4 Low; 5 Moderate; 6-7 High; 8-10 Very high. | Median | Inter-Quartile Range | units on a scale |
|
Participants receive up to 7 nondirective smoking cessation coaching telephone calls from the quitline over 9 weeks. Nondirective smoking cessation coaching: Quitline coach allows participant to set agenda for each call. |
|
|
|
| 0 |
| 258 |
| 0 |
| 258 |
| EG001 | Nondirective | Participants receive up to 7 nondirective smoking cessation coaching telephone calls from the quitline over 9 weeks. Nondirective smoking cessation coaching: Quitline coach allows participant to set agenda for each call. | 0 | 260 | 0 | 260 |
Not provided
Not provided