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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Smoking Cessation Treatment | Experimental | The intervention will consist of Contingency management (CM) in conjunction with effective first line pharmacotherapy (dual nicotine replacement therapy [NRT] or varenicline) and brief counseling to rapidly induce cessation and to maintain abstinence long term. Pharmacotherapy will be flexible. Participants will also be given the option of receiving additional behavioral support by being referred to the CT Quitline and using text or mobile phone apps for quitting. |
|
| Delayed Treatment Control | No Intervention | Participants in this arm will be offered the Smoking Cessation Treatment 6 weeks later |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contingency management | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 weeks |
| 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. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephanie O'Malley, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | New Haven | Connecticut | 06511 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | 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. | These analyses are conducted for the subset of dining hall employees who reported being smokers. | Posted | Count of Participants | Participants | 6 weeks |
|
Adverse event data were collected for the treatment period through 6 month follow-up.
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 because both groups received the same treatment components so we did not differentiate outcomes or adverse events between arm/group.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants Who Enrolled in Treatment | All participants who enrolled in treatment in either the intervention condition or delayed treatment control were followed after treatment to determine smoking cessation and adverse event outcomes because all participants ultimately received the same treatment components. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Krysten Bold | Yale University School of Medicine | 2039747603 | krysten.bold@yale.edu |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000095488 | Nicotine Replacement Therapy |
| D000068580 | Varenicline |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Nicotine replacement therapy | Drug | Participants have the option of using nicotine patch in combination with nicotine gum or lozenge |
|
| Varenicline | Drug | Individuals who do not respond initially to Nicotine Replacement Therapy will be offered varenicline as an alternative |
|
| Additional behavioral support | Behavioral | 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 |
|
|
| Month 2 |
| 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). | Month 3 |
| 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). | Month 4 |
| 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). | Month 5 |
| 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). | Month 6 |
| 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. | Baseline |
| 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. | Month 6 |
| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Delayed Treatment Control | Participants in this arm will be offered the Smoking Cessation Treatment 6 weeks later |
|
|
| 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. | These analyses are conducted for the subset of dining hall employees who reported being smokers. | Posted | Count of Participants | Participants | 6 weeks |
|
|
|
| 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). | 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. | Posted | Count of Participants | Participants | Month 2 |
|
|
|
| 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). | 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. | Posted | Count of Participants | Participants | Month 3 |
|
|
|
| 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). | 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. | Posted | Count of Participants | Participants | Month 4 |
|
|
|
| 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). | 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. | Posted | Count of Participants | Participants | Month 5 |
|
|
|
| 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). | 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. | Posted | Count of Participants | Participants | Month 6 |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Month 6 |
|
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| 0 |
| 25 |
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| 25 |
| 0 |
| 25 |
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| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011810 | Quinoxalines |