NCT03002883

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
113

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 26, 2016

Completed
Last Updated

March 30, 2017

Status Verified

March 1, 2017

Enrollment Period

1.8 years

First QC Date

December 19, 2016

Last Update Submit

March 29, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Biochemically validated smoking cessation

    Point prevalence abstinence validated by saliva cotinine level

    6 months

Secondary Outcomes (3)

  • Self-reported smoking cessation

    6 months

  • Self-reported smoking cessation

    3 months

  • Self-reported smoking cessation

    1 month

Study Arms (3)

Usual Care

PLACEBO COMPARATOR

Students referred to student health for tobacco cessation resources including campus "Quit Kits"

Behavioral: Usual Care

Brief Motivational Interviewing

ACTIVE COMPARATOR

Students received brief motivational interviewing by a student peer educator about tobacco cessation

Behavioral: Usual CareBehavioral: Brief Motivational Interviewing

Direct referral to quitline

ACTIVE COMPARATOR

Students were directly referred to the state quitline for follow-up counseling

Behavioral: Usual CareBehavioral: Direct referral to quitline

Interventions

Usual CareBEHAVIORAL

Participant provided "Quit Kit" water bottle with small cessation aids (eg. sunflower seeds) and educated about student health as a cessation resource

Brief Motivational InterviewingDirect referral to quitlineUsual Care

Peer educator conducts brief motivational interviewing about smoking cessation and participant goals

Brief Motivational Interviewing

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

Direct referral to quitline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Elisa Tong, MD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2016

First Posted

December 26, 2016

Study Start

September 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

March 30, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share