NCT01639079

Brief Summary

The primary goal of this project is to carry out a randomized controlled trial (RCT) comparing quit rates of a Spanish/English stop smoking Web site to those of a no-intervention or "quit on your own" control. The investigators have not included a no-intervention condition in previous Web studies and although 20% of participants quit smoking at one year are 20%, obtaining evidence that the investigators interventions yield higher abstinence rates than a no-intervention control is the next logical step. Furthermore, although the investigators Web site was designed in English and Spanish, the investigators success in attracting the U.S. Hispanic/Latino (HL) population in either language has been limited, so this project only will only conduct intensive telephone follow-up of HL smokers and add new recruitment methods to do so.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
146

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

June 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 10, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 12, 2012

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

November 15, 2018

Status Verified

November 1, 2018

Enrollment Period

3.8 years

First QC Date

July 10, 2012

Last Update Submit

November 13, 2018

Conditions

Cigarette SmokingNicotine Dependence

Keywords

cigarette smoking behaviorsmoking cessationLatino smoking cessation

Outcome Measures

Primary Outcomes (1)

  • smoking abstinence

    no cigarettes smoked in the week and/or month prior to completion of the follow-up survey

    6 months

Secondary Outcomes (1)

  • Smoking fewer cigarettes

    6 months

Study Arms (2)

Usual Care for Smoking

NO INTERVENTION

Usual care for smoking cessation with access to the web site after 6 months

Internet Smoking Cessation Web Site

EXPERIMENTAL

Internet Stop Smoking site (TC5) offers a menu of several intervention elements from which the participants may choose as many as they wish. The links (URLs) to register for the study are: English: www.stopsmoking.ucsf.edu Spanish: https://www.stopsmoking.ucsf.edu/es/intro/home.aspx

Behavioral: Internet Smoking Cessation Web Site

Interventions

Internet Smoking Cessation Web SiteBEHAVIORAL

Internet Stop Smoking site (TC5) with several intervention elements from which the participants may choose as many as they wish. The links (URLs) to register for the study are: English: www.stopsmoking.ucsf.edu Spanish: https://www.stopsmoking.ucsf.edu/es/intro/home.aspx

Also known as: Tomando Control, UCSF Stop Smoking Web Site
Internet Smoking Cessation Web Site

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 18 or older
  • daily (smoking one or more cigarettes per day) or non-daily (smoke some days) smoker
  • planning to quit within the next month
  • have a valid e-mail address so to send a password required to consent online.
  • speak English or Spanish
  • consent to participate

You may not qualify if:

  • does not speak English or Spanish
  • age younger than 18 years
  • non-smoker
  • no valid email address
  • Note - You do not need to contact anyone to begin this study. Please access the following URLs to participate: English: www.stopsmoking.ucsf.edu Spanish: https://www.stopsmoking.ucsf.edu/es/intro/home.aspx

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143-0320, United States

Location

MeSH Terms

Conditions

Cigarette SmokingTobacco Use DisorderSmoking Cessation

Condition Hierarchy (Ancestors)

Tobacco SmokingSmokingBehaviorTobacco UseSubstance-Related DisordersChemically-Induced DisordersMental DisordersHealth Behavior

Study Officials

  • Ricardo F. Muñoz, PhD

    University of California, San Francisco

    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

July 10, 2012

First Posted

July 12, 2012

Study Start

June 1, 2012

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

November 15, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)