A Smoking Cessation Intervention for Yale Dining Employees

Smoking Cessation Clinical Trial

Official title:

A Smoking Cessation Intervention for Yale Dining Employees

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02562521
• Other study ID #: 1411014980
• Status: Completed
• Phase: Phase 4
• First received: September 25, 2015
• Last updated: March 9, 2018
• Start date: September 2015
• Est. completion date: December 2016

Study information

• Verified date: March 2018
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Behavioral:
• Contingency 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.

Drug:
• Nicotine replacement therapy
Participants have the option of using nicotine patch in combination with nicotine gum or lozenge
• Varenicline
Individuals who do not respond initially to Nicotine Replacement Therapy will be offered varenicline as an alternative

Behavioral:
• Additional 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

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	6 weeks
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.	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).	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).	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).	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).	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).	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.	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.	Month 6