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A Smoking Cessation Intervention for Yale Dining Employees

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ClinicalTrials.gov Identifier: NCT02562521
Recruitment Status : Completed
First Posted : September 29, 2015
Results First Posted : April 9, 2018
Last Update Posted : April 9, 2018
Sponsor:
Information provided by (Responsible Party):
Yale University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Smoking Cessation
Interventions Behavioral: Contingency management
Drug: Nicotine replacement therapy
Drug: Varenicline
Behavioral: Additional behavioral support
Enrollment 25
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Test Site Participants Control Site Participants
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 18 7
Completed 18 7
Not Completed 0 0
Arm/Group Title Test Site Participants Control Site Participants Total
Hide Arm/Group Description 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 18 7 25
Hide Baseline Analysis Population Description
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.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants 7 participants 25 participants
44.2  (13.3) 43.2  (11.6) 44.0  (12.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 7 participants 25 participants
Female
10
  55.6%
6
  85.7%
16
  64.0%
Male
8
  44.4%
1
  14.3%
9
  36.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 7 participants 25 participants
Hispanic or Latino
1
   5.6%
0
   0.0%
1
   4.0%
Not Hispanic or Latino
14
  77.8%
7
 100.0%
21
  84.0%
Unknown or Not Reported
3
  16.7%
0
   0.0%
3
  12.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 7 participants 25 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
12
  66.7%
4
  57.1%
16
  64.0%
White
2
  11.1%
2
  28.6%
4
  16.0%
More than one race
2
  11.1%
0
   0.0%
2
   8.0%
Unknown or Not Reported
2
  11.1%
1
  14.3%
3
  12.0%
1.Primary Outcome
Title Number of Participants With a Smoking Quit Attempt in the Prior Six Weeks
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
These analyses are conducted for the subset of dining hall employees who reported being smokers.
Arm/Group Title Smoking Cessation Treatment Delayed Treatment Control
Hide Arm/Group Description:

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.

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.

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

Additional behavioral support: Based on interest,

Participants in this arm will be offered the Smoking Cessation Treatment 6 weeks later
Overall Number of Participants Analyzed 15 8
Measure Type: Count of Participants
Unit of Measure: Participants
10
  66.7%
1
  12.5%
2.Primary Outcome
Title Number of Participants Who Quit Smoking for at Least 24 Hours in the Prior Six Weeks
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
These analyses are conducted for the subset of dining hall employees who reported being smokers.
Arm/Group Title Smoking Cessation Treatment Delayed Treatment Control
Hide Arm/Group Description:

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.

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.

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

Additional behavioral support: Based on interest,

Participants in this arm will be offered the Smoking Cessation Treatment 6 weeks later
Overall Number of Participants Analyzed 15 8
Measure Type: Count of Participants
Unit of Measure: Participants
8
  53.3%
1
  12.5%
3.Secondary Outcome
Title Number of Participants Who Quit Smoking at 2 Months
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title All Participants Enrolled in Treatment
Hide Arm/Group Description:
All participants who enrolled in treatment in either the intervention condition or delayed treatment control were followed after treatment to determine smoking cessation outcomes.
Overall Number of Participants Analyzed 25
Measure Type: Count of Participants
Unit of Measure: Participants
2
   8.0%
4.Secondary Outcome
Title Number of Participants Who Quit Smoking at 3 Months
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title All Participants Enrolled in Treatment
Hide Arm/Group Description:
All participants who enrolled in treatment in either the intervention condition or delayed treatment control were followed after treatment to determine smoking cessation outcomes.
Overall Number of Participants Analyzed 25
Measure Type: Count of Participants
Unit of Measure: Participants
1
   4.0%
5.Secondary Outcome
Title Number of People Who Quit Smoking at 4 Months
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title All Participants Enrolled in Treatment
Hide Arm/Group Description:
All participants who enrolled in treatment in either the intervention condition or delayed treatment control were followed after treatment to determine smoking cessation outcomes.
Overall Number of Participants Analyzed 25
Measure Type: Count of Participants
Unit of Measure: Participants
4
  16.0%
6.Secondary Outcome
Title Number of People Who Quit Smoking at 5 Months
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title All Participants Enrolled in Treatment
Hide Arm/Group Description:
All participants who enrolled in treatment in either the intervention condition or delayed treatment control were followed after treatment to determine smoking cessation outcomes.
Overall Number of Participants Analyzed 25
Measure Type: Count of Participants
Unit of Measure: Participants
2
   8.0%
7.Secondary Outcome
Title Number of People Who Quit Smoking at 6 Months
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title All Participants Enrolled in Treatment
Hide Arm/Group Description:
All participants who enrolled in treatment in either the intervention condition or delayed treatment control were followed after treatment to determine smoking cessation outcomes.
Overall Number of Participants Analyzed 25
Measure Type: Count of Participants
Unit of Measure: Participants
1
   4.0%
8.Secondary Outcome
Title Wisconsin Predicting Patient’s Relapse Questionnaire
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title All Participants Enrolled in Treatment
Hide Arm/Group Description:
All participants who enrolled in treatment in either the intervention condition or delayed treatment control were followed after treatment to determine smoking cessation outcomes.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.64  (1.96)
9.Secondary Outcome
Title Wisconsin Predicting Patient’s Relapse Questionnaire
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title All Participants Enrolled in Treatment
Hide Arm/Group Description:
All participants who enrolled in treatment in either the intervention condition or delayed treatment control were followed after treatment to determine smoking cessation outcomes.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.80  (1.74)
Time Frame Adverse event data were collected for the treatment period through 6 month follow-up.
Adverse Event Reporting Description 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.
 
Arm/Group Title All Participants Who Enrolled in Treatment
Hide Arm/Group Description 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.
All-Cause Mortality
All Participants Who Enrolled in Treatment
Affected / at Risk (%)
Total   0/25 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
All Participants Who Enrolled in Treatment
Affected / at Risk (%)
Total   0/25 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
All Participants Who Enrolled in Treatment
Affected / at Risk (%)
Total   0/25 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Krysten Bold
Organization: Yale University School of Medicine
Phone: 2039747603
EMail: krysten.bold@yale.edu
Layout table for additonal information
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02562521     History of Changes
Other Study ID Numbers: 1411014980
First Submitted: September 25, 2015
First Posted: September 29, 2015
Results First Submitted: January 11, 2018
Results First Posted: April 9, 2018
Last Update Posted: April 9, 2018