Smoking Cessation
Conditions
Brief summary
The purpose of this study is to evaluate a smoking cessation program for employees at the Yale University dining hall. Two pilot dining halls and six paired dining halls (3 test and 3 control sites) will be offered a contingency management/pharmacotherapy smoking cessation intervention at the work site.
Detailed description
The primary aim of this study is to test the effect of a smoking cessation intervention provided to Yale University dining hall employees on smoking quit rates and quit attempts at the end of six weeks of treatment. It is hypothesized that participants from the test site will have higher rates of smoking cessation and quit attempts compared to participants from the control site. In addition, this study will examine the number of participants who enroll in the smoking cessation program who successfully quit smoking at 6 months. There will be 3 test sites and 3 control sites in this study (broken down into 3 pairs of test/control). Each test site will be matched to on a control site. Self-reported smoking status will be obtained for all participants in the test and control sites at 3 time points (baseline, 6 weeks and 6 months). The study start time for each pair will be delayed by 4-8 weeks for feasibility issues.
Interventions
BEHAVIORALContingency management
Participants in the intervention group will receive a tailored intervention that utilizes contingency management in which they receive monetary rewards for reducing or quitting smoking.
DRUGNicotine replacement therapy
Participants have the option of using nicotine patch in combination with nicotine gum or lozenge
DRUGVarenicline
Individuals who do not respond initially to Nicotine Replacement Therapy will be offered varenicline as an alternative
BEHAVIORALAdditional behavioral support
Based on interest, participants can be referred to a telephone quitline or receive access to mobile text messaging programs or app based smoking cessation support
Sponsors
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Current smoker * Interested in receiving treatment for quitting smoking. * Employed for more than 20 hours per week by one of the 7 residential college dining halls selected for inclusion in this study. * English speaker.
Exclusion criteria
* None specified, other than failure to meet all inclusion criteria listed above.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Smoking Quit Attempt in the Prior Six Weeks | 6 weeks | A survey of dining hall employees will be used to determine the proportion of the dining hall employees who made a quit attempt in the prior six weeks in the treatment and delayed treatment control groups. Values present the proportion of dining hall employees who smoke who reported making a quit attempt. |
| Number of Participants Who Quit Smoking for at Least 24 Hours in the Prior Six Weeks | 6 weeks | A survey of dining hall employees will be used to determine the proportion of the dining hall employees who quit smoking for at least 24 hours in the prior six weeks in the treatment and delayed treatment control groups. Values present the number of individuals who report quitting successfully for at least 24 hours among individuals who reported smoking. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of People Who Quit Smoking at 4 Months | Month 4 | Smoking cessation is operationally defined as successfully quitting smoking at 4 months measured with TLFB (a standardized, validated, and reliable experimenter-administered rating scale that will be used to obtain quantity and frequency estimates of smoking) and confirmed with expired breath carbon monoxide reading (CO less than or equal to 4 parts per million). |
| Number of People Who Quit Smoking at 5 Months | Month 5 | Smoking cessation is operationally defined as successfully quitting smoking at 5 months measured with TLFB (a standardized, validated, and reliable experimenter-administered rating scale that will be used to obtain quantity and frequency estimates of smoking) and confirmed with expired breath carbon monoxide reading (CO less than or equal to 4 parts per million). |
| Number of Participants Who Quit Smoking at 2 Months | Month 2 | Smoking cessation is operationally defined as successfully quitting smoking at 2 months measured with TLFB (a standardized, validated, and reliable experimenter-administered rating scale that will be used to obtain quantity and frequency estimates of smoking) and confirmed with expired breath carbon monoxide reading (CO less than or equal to 4 parts per million). |
| Wisconsin Predicting Patient's Relapse Questionnaire | Baseline | Items from the Wisconsin Predicting Patient's Relapse questionnaire (WI-PREPARE) will be administered. This is a brief scale comprised of 7 items that assesses proneness to smoking relapse. Items are summed to create a total score. Total range=1-13 with higher scores indicating greater likelihood of smoking relapse. |
| Number of People Who Quit Smoking at 6 Months | Month 6 | Smoking cessation is operationally defined as successfully quitting smoking at 6 months measured with TLFB (a standardized, validated, and reliable experimenter-administered rating scale that will be used to obtain quantity and frequency estimates of smoking) and confirmed with expired breath carbon monoxide reading (CO less than or equal to 4 parts per million). |
| Number of Participants Who Quit Smoking at 3 Months | Month 3 | Smoking cessation is operationally defined as successfully quitting smoking at 3 months measured with TLFB (a standardized, validated, and reliable experimenter-administered rating scale that will be used to obtain quantity and frequency estimates of smoking) and confirmed with expired breath carbon monoxide reading (CO less than or equal to 4 parts per million). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Test Site Participants Dining hall employees who were current smokers were invited to participate in a treatment research study. Participants in the test and control sites received the same treatment components with a time delay where the control site started treatment 6 weeks after the test site. | 18 |
| Control Site Participants Dining hall employees who were current smokers were invited to participate in a treatment research study. Participants in the test and control sites received the same treatment components with a time delay where the control site started treatment 6 weeks after the test site. | 7 |
| Total | 25 |
Baseline characteristics
| Characteristic | Test Site Participants | Total | Control Site Participants |
|---|---|---|---|
| Age, Continuous | 44.2 years STANDARD_DEVIATION 13.3 | 44.0 years STANDARD_DEVIATION 12.6 | 43.2 years STANDARD_DEVIATION 11.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 21 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants | 16 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) White | 2 Participants | 4 Participants | 2 Participants |
| Sex: Female, Male Female | 10 Participants | 16 Participants | 6 Participants |
| Sex: Female, Male Male | 8 Participants | 9 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
Primary
Number of Participants Who Quit Smoking for at Least 24 Hours in the Prior Six Weeks
A survey of dining hall employees will be used to determine the proportion of the dining hall employees who quit smoking for at least 24 hours in the prior six weeks in the treatment and delayed treatment control groups. Values present the number of individuals who report quitting successfully for at least 24 hours among individuals who reported smoking.
Time frame: 6 weeks
Population: These analyses are conducted for the subset of dining hall employees who reported being smokers.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Smoking Cessation Treatment | Number of Participants Who Quit Smoking for at Least 24 Hours in the Prior Six Weeks | 8 Participants |
| Delayed Treatment Control | Number of Participants Who Quit Smoking for at Least 24 Hours in the Prior Six Weeks | 1 Participants |
Primary
Number of Participants With a Smoking Quit Attempt in the Prior Six Weeks
A survey of dining hall employees will be used to determine the proportion of the dining hall employees who made a quit attempt in the prior six weeks in the treatment and delayed treatment control groups. Values present the proportion of dining hall employees who smoke who reported making a quit attempt.
Time frame: 6 weeks
Population: These analyses are conducted for the subset of dining hall employees who reported being smokers.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Smoking Cessation Treatment | Number of Participants With a Smoking Quit Attempt in the Prior Six Weeks | 10 Participants |
| Delayed Treatment Control | Number of Participants With a Smoking Quit Attempt in the Prior Six Weeks | 1 Participants |
Secondary
Number of Participants Who Quit Smoking at 2 Months
Smoking cessation is operationally defined as successfully quitting smoking at 2 months measured with TLFB (a standardized, validated, and reliable experimenter-administered rating scale that will be used to obtain quantity and frequency estimates of smoking) and confirmed with expired breath carbon monoxide reading (CO less than or equal to 4 parts per million).
Time frame: Month 2
Population: These analyses are conducted for the subset of dining hall employees who enrolled in the treatment program. Results are combined across the treatment and delayed control groups during the follow-up period because both groups received the same treatment components so we did not differentiate outcomes between arm/group during the follow-up period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Smoking Cessation Treatment | Number of Participants Who Quit Smoking at 2 Months | 2 Participants |
Secondary
Number of Participants Who Quit Smoking at 3 Months
Smoking cessation is operationally defined as successfully quitting smoking at 3 months measured with TLFB (a standardized, validated, and reliable experimenter-administered rating scale that will be used to obtain quantity and frequency estimates of smoking) and confirmed with expired breath carbon monoxide reading (CO less than or equal to 4 parts per million).
Time frame: Month 3
Population: These analyses are conducted for the subset of dining hall employees who enrolled in the treatment program. Results are combined across the treatment and delayed control groups during the follow-up period because both groups received the same treatment components so we did not differentiate outcomes between arm/group during the follow-up period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Smoking Cessation Treatment | Number of Participants Who Quit Smoking at 3 Months | 1 Participants |
Secondary
Number of People Who Quit Smoking at 4 Months
Smoking cessation is operationally defined as successfully quitting smoking at 4 months measured with TLFB (a standardized, validated, and reliable experimenter-administered rating scale that will be used to obtain quantity and frequency estimates of smoking) and confirmed with expired breath carbon monoxide reading (CO less than or equal to 4 parts per million).
Time frame: Month 4
Population: These analyses are conducted for the subset of dining hall employees who enrolled in the treatment program. Results are combined across the treatment and delayed control groups during the follow-up period because both groups received the same treatment components so we did not differentiate outcomes between arm/group during the follow-up period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Smoking Cessation Treatment | Number of People Who Quit Smoking at 4 Months | 4 Participants |
Secondary
Number of People Who Quit Smoking at 5 Months
Smoking cessation is operationally defined as successfully quitting smoking at 5 months measured with TLFB (a standardized, validated, and reliable experimenter-administered rating scale that will be used to obtain quantity and frequency estimates of smoking) and confirmed with expired breath carbon monoxide reading (CO less than or equal to 4 parts per million).
Time frame: Month 5
Population: These analyses are conducted for the subset of dining hall employees who enrolled in the treatment program. Results are combined across the treatment and delayed control groups during the follow-up period because both groups received the same treatment components so we did not differentiate outcomes between arm/group during the follow-up period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Smoking Cessation Treatment | Number of People Who Quit Smoking at 5 Months | 2 Participants |
Secondary
Number of People Who Quit Smoking at 6 Months
Smoking cessation is operationally defined as successfully quitting smoking at 6 months measured with TLFB (a standardized, validated, and reliable experimenter-administered rating scale that will be used to obtain quantity and frequency estimates of smoking) and confirmed with expired breath carbon monoxide reading (CO less than or equal to 4 parts per million).
Time frame: Month 6
Population: These analyses are conducted for the subset of dining hall employees who enrolled in the treatment program. Results are combined across the treatment and delayed control groups during the follow-up period because both groups received the same treatment components so we did not differentiate outcomes between arm/group during the follow-up period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Smoking Cessation Treatment | Number of People Who Quit Smoking at 6 Months | 1 Participants |
Secondary
Wisconsin Predicting Patient's Relapse Questionnaire
Items from the Wisconsin Predicting Patient's Relapse questionnaire (WI-PREPARE) will be administered. This is a brief scale comprised of 7 items that assesses proneness to smoking relapse. Items are summed to create a total score. Total range=1-13 with higher scores indicating greater likelihood of smoking relapse.
Time frame: Baseline
Population: These analyses are conducted for the subset of dining hall employees who enrolled in the treatment program. Results are combined across the treatment and delayed control groups during the follow-up period because both groups received the same treatment components so we did not differentiate outcomes between arm/group during the follow-up period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Smoking Cessation Treatment | Wisconsin Predicting Patient's Relapse Questionnaire | 5.64 units on a scale | Standard Deviation 1.96 |
Secondary
Wisconsin Predicting Patient's Relapse Questionnaire
Items from the Wisconsin Predicting Patient's Relapse questionnaire (WI-PREPARE) will be administered. This is a brief scale comprised of 7 items that assesses proneness to smoking relapse. Items are summed to create a total score. Total range=1-13 with higher scores indicating greater likelihood of smoking relapse.
Time frame: Month 6
Population: These analyses are conducted for the subset of dining hall employees who enrolled in the treatment program. Results are combined across the treatment and delayed control groups during the follow-up period because both groups received the same treatment components so we did not differentiate outcomes between arm/group during the follow-up period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Smoking Cessation Treatment | Wisconsin Predicting Patient's Relapse Questionnaire | 4.80 units on a scale | Standard Deviation 1.74 |