Trial Outcomes & Findings for A Smoking Cessation Intervention for Yale Dining Employees (NCT NCT02562521)

NCT ID: NCT02562521

Last Updated: 2018-04-09

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 25 participants
• Primary outcome timeframe: 6 weeks
• Results posted on: 2018-04-09

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	18	7
Overall Study COMPLETED	18	7
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Smoking Cessation Intervention for Yale Dining Employees

Baseline characteristics by cohort

Measure	Test Site Participants n=18 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.	Control Site Participants n=7 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.	Total n=25 Participants Total of all reporting groups
Age, Continuous	44.2 years STANDARD_DEVIATION 13.3 • n=5 Participants	43.2 years STANDARD_DEVIATION 11.6 • n=7 Participants	44.0 years STANDARD_DEVIATION 12.6 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	6 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	1 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=5 Participants	7 Participants n=7 Participants	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	12 Participants n=5 Participants	4 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: These analyses are conducted for the subset of dining hall employees who reported being smokers.

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.

Outcome measures

Measure	Smoking Cessation Treatment n=15 Participants 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,	Delayed Treatment Control n=8 Participants Participants in this arm will be offered the Smoking Cessation Treatment 6 weeks later
Number of Participants With a Smoking Quit Attempt in the Prior Six Weeks	10 Participants	1 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: These analyses are conducted for the subset of dining hall employees who reported being smokers.

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.

Outcome measures

Measure	Smoking Cessation Treatment n=15 Participants 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,	Delayed Treatment Control n=8 Participants Participants in this arm will be offered the Smoking Cessation Treatment 6 weeks later
Number of Participants Who Quit Smoking for at Least 24 Hours in the Prior Six Weeks	8 Participants	1 Participants

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Measure	Smoking Cessation Treatment n=25 Participants 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,	Delayed Treatment Control Participants in this arm will be offered the Smoking Cessation Treatment 6 weeks later
Number of Participants Who Quit Smoking at 2 Months	2 Participants	—

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Measure	Smoking Cessation Treatment n=25 Participants 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,	Delayed Treatment Control Participants in this arm will be offered the Smoking Cessation Treatment 6 weeks later
Number of Participants Who Quit Smoking at 3 Months	1 Participants	—

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Measure	Smoking Cessation Treatment n=25 Participants 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,	Delayed Treatment Control Participants in this arm will be offered the Smoking Cessation Treatment 6 weeks later
Number of People Who Quit Smoking at 4 Months	4 Participants	—

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Measure	Smoking Cessation Treatment n=25 Participants 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,	Delayed Treatment Control Participants in this arm will be offered the Smoking Cessation Treatment 6 weeks later
Number of People Who Quit Smoking at 5 Months	2 Participants	—

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Measure	Smoking Cessation Treatment n=25 Participants 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,	Delayed Treatment Control Participants in this arm will be offered the Smoking Cessation Treatment 6 weeks later
Number of People Who Quit Smoking at 6 Months	1 Participants	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Smoking Cessation Treatment n=25 Participants 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,	Delayed Treatment Control Participants in this arm will be offered the Smoking Cessation Treatment 6 weeks later
Wisconsin Predicting Patient's Relapse Questionnaire	5.64 units on a scale Standard Deviation 1.96	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Smoking Cessation Treatment n=25 Participants 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,	Delayed Treatment Control Participants in this arm will be offered the Smoking Cessation Treatment 6 weeks later
Wisconsin Predicting Patient's Relapse Questionnaire	4.80 units on a scale Standard Deviation 1.74	—

Adverse Events

All Participants Who Enrolled in Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Krysten Bold

Yale University School of Medicine

Phone: 2039747603

Email: krysten.bold@yale.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place