Skip to main content
OpenTrials
Completed

NCT Number: NCT02562521

A Smoking Cessation Intervention for Yale Dining Employees

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Yale University

New Haven, Connecticut, 06511, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

Other names: telephone quit lines and mobile applications

Primary outcomes

  1. Number of Participants With a Smoking Quit Attempt in the Prior Six Weeks

    Time frame: 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.

  2. Number of Participants Who Quit Smoking for at Least 24 Hours in the Prior Six Weeks

    Time frame: 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 outcomes

  1. Number of Participants Who Quit Smoking at 2 Months

    Time frame: 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).

  2. Number of Participants Who Quit Smoking at 3 Months

    Time frame: 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).

  3. Number of People Who Quit Smoking at 4 Months

    Time frame: 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).

  4. Number of People Who Quit Smoking at 5 Months

    Time frame: 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).

  5. Number of People Who Quit Smoking at 6 Months

    Time frame: 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).

  6. Wisconsin Predicting Patient's Relapse Questionnaire

    Time frame: 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.

  7. Wisconsin Predicting Patient's Relapse Questionnaire

    Time frame: Month 6

    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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 29, 2015
Registry last updated
Apr 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.