STAND Community College Tobacco Cessation Trial

Sacramento Taking Action Against Nicotine Dependence (STAND) at Sacramento City College

Community colleges have 45% of the nation's undergraduates and have a higher smoking prevalence rate than 4-year colleges. California's community colleges comprise the nation's largest higher education system, and Sacramento has the second largest community college district. As more colleges are encouraged to become smoke and tobacco-free campuses, smokers enrolled at community college campuses need greater support. However, community colleges may lack the student health clinic resources that 4-year colleges have for students who live on campus. Little evidence to date demonstrates effective interventions for smokers on community college campuses.

This pilot study seeks to demonstrate the feasibility and promising outcomes of two cessation interventions, compared with usual care on a community college campus. The first intervention was based on a promising model of brief motivational interviewing delivered by peer educators, developed by the community lead Breathe California of Sacramento-Emigrant Trails (BCSET) through the Sacramento Taking Action Against Tobacco Dependence (STAND) project. The second intervention was based on direct enrollment into the California Smokers' Helpline, which has demonstrated utility for promoting smoking cessation among young adults with low socioeconomic status. Usual care consisted of students going to the student health center for smoking cessation assistance.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Behavioral: Usual Care; Behavioral: Brief Motivational Interviewing; Behavioral: Direct referral to quitline

• Study Type: Interventional
• Enrollment (Actual): 113
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• adult 18 years or older
• current smoker in the past 30 days
• smoker wants to quit
• smoker not currently participating in other smoking cessation activities, and
• smoker must be willing to accept randomization into any of the 3 study arms

Exclusion Criteria:

• students not proficient in communicating in English
• adults unable to consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Usual Care; Students referred to student health for tobacco cessation resources including campus "Quit Kits"	Behavioral: Usual Care; Participant provided "Quit Kit" water bottle with small cessation aids (eg. sunflower seeds) and educated about student health as a cessation resource
Active Comparator: Brief Motivational Interviewing; Students received brief motivational interviewing by a student peer educator about tobacco cessation	Behavioral: Usual Care; Participant provided "Quit Kit" water bottle with small cessation aids (eg. sunflower seeds) and educated about student health as a cessation resource; Behavioral: Brief Motivational Interviewing; Peer educator conducts brief motivational interviewing about smoking cessation and participant goals
Active Comparator: Direct referral to quitline; Students were directly referred to the state quitline for follow-up counseling	Behavioral: Usual Care; Participant provided "Quit Kit" water bottle with small cessation aids (eg. sunflower seeds) and educated about student health as a cessation resource; Behavioral: Direct referral to quitline; Peer educator educates about state quitline services and gets verbal consent to use quitline's direct referral web portal for quitline to contact participant in 1-2 business days about free counseling services to make a quit plan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biochemically validated smoking cessation	Point prevalence abstinence validated by saliva cotinine level	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported smoking cessation	Point prevalence abstinence by self-report on survey	6 months
Self-reported smoking cessation	Point prevalence abstinence by self-report on survey	3 months
Self-reported smoking cessation	Point prevalence abstinence by self-report on survey	1 month

Collaborators and Investigators

• Sponsor: University of California, Davis
• Collaborators: Tobacco Related Disease Research Program; Breathe California of Sacramento-Emigrant Trails; Sacramento City College
• Investigators: Principal Investigator: Elisa Tong, MD, University of California, Davis

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: December 19, 2016
• First Submitted That Met QC Criteria: December 21, 2016
• First Posted (Estimate): December 26, 2016

Study Record Updates

• Last Update Posted (Actual): March 30, 2017
• Last Update Submitted That Met QC Criteria: March 29, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 491744; 22BT-0057 (Other Identifier: Other)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO