Tobacco Status Project: Social Media Intervention for Young Adult Smokers (TSP)

Social Media Intervention for Young Adult Smokers

This randomized clinical trial will test the efficacy of a Facebook intervention based on the Transtheoretical Model (Prochaska and DiClemente) and US Public Health Service Clinical Practice Guidelines with young adults who smoke cigarettes who are age 18 to 25 (N=480).

Study Overview

Status

Completed

Conditions

Detailed Description

Participants will be randomized to one of two conditions: (1) a Facebook-delivered intervention tailored to readiness to quit smoking; or (2) the control condition (referral to the Smokefree.gov website). The intervention will include 12 weeks of Facebook-based messages and activities tailored to participants' stage of change.

Assessments will occur at baseline, 3, 6, and 12 months follow-up. Assessments will include measures on smoking patterns and thoughts about abstinence. All participants who report no past 7-day smoking will be asked to give biochemical verification of smoking status with saliva cotinine test kits that will be mailed to participants.

Study Type

Interventional

Enrollment (Actual)

501

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • San Francisco, California, United States, 94143
        • University of California San Francisco Department of Psychiatry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 25 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ages 18-25 years old
  • english literate
  • have access to Smartphone or computer with camera
  • indicate they go on Facebook "most" (≥ 4) days per week
  • have smoked ≥100 cigarettes in their lives and currently smoke at least 1 cigarette per day on 3 or more days of the week

Exclusion Criteria:

  • do not read English
  • younger than 18 or older than 25 years of age
  • do not have access to a Smartphone or computer with a camera
  • only go on Facebook 3 or fewer days a week
  • have smoked less than 100 cigarettes in their lifetime or do not currently smoke at least 1 cigarette per day on 3 or more days of the week

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Facebook intervention
Assignment to private group on Facebook with 3 months of content delivered to the group.
90 days of Facebook messaging, weekly Ask the Doctor sessions
Active Comparator: Referral
Referral to smokefree.gov website
referral to the NCI Smokefree.gov website

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
7-day point prevalence abstinence at 3 months
Time Frame: 3 months post baseline
Reports of no smoking in the 7 days prior to the 3 month assessment. Biochemical verification of abstinence will also be recorded.
3 months post baseline
7-day point prevalence abstinence at 6 months
Time Frame: 6 months post baseline
Reports of no smoking in the 7 days prior to the 6 month assessment. Biochemical verification of abstinence will also be recorded.
6 months post baseline
7-day point prevalence abstinence at 12 months
Time Frame: 12 months post baseline
Reports of no smoking in the 7 days prior to the 12 month assessment. Biochemical verification of abstinence will also be recorded.
12 months post baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in cigarettes smoked by at least 50% between Baseline and each follow-up timepoint
Time Frame: 3, 6, and 12 months post baseline
Reduction will be assessed at 3, 6, and 12 month follow-ups.
3, 6, and 12 months post baseline
Quit attempts
Time Frame: 3, 6, and 12 month post-baseline
Quit attempt during the follow-up period at 3, 6, and 12 months post-baseline.
3, 6, and 12 month post-baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health risk behaviors
Time Frame: 3, 6, and 12 months post baseline
We will assess prevalence rates of health risk behaviors other than smoking including recent alcohol and illicit drug use, poor sleep quality, sedentary behavior, poor diet, depression, and high risk sexual behavior.
3, 6, and 12 months post baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Danielle A Ramo, PhD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

May 13, 2014

First Submitted That Met QC Criteria

July 30, 2014

First Posted (Estimate)

August 1, 2014

Study Record Updates

Last Update Posted (Actual)

May 8, 2017

Last Update Submitted That Met QC Criteria

May 5, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • A119678
  • 5K23DA032578 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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