SmokingTSPNCT02207036
Tobacco Status Project: Social Media Intervention for Young Adult Smokers
A study testing Facebook intervention and Smokefree.gov in people with Smoking, run by University of California, San Francisco at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- Facebook intervention and Smokefree.gov
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 501 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco Department of Psychiatry
San Francisco, California, 94143
About this study
Official title: 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).
Read the 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.
- Conditions
- Smoking
- Being tested
- Facebook intervention, Smokefree.gov
- Keywords
- Tobacco, cigarettes, cessation, intervention, young adults, Internet, social media, mobile health
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facebook interventionBehavioural
90 days of Facebook messaging, weekly Ask the Doctor sessions
Smokefree.govBehavioural
referral to the NCI Smokefree.gov website
| Study group | Role | What they receive |
|---|---|---|
| Facebook intervention | Experimental | Assignment to private group on Facebook with 3 months of content delivered to the group. Receives: Behavioral: Facebook intervention |
| Referral | Active comparator | Referral to smokefree.gov website Receives: Behavioral: Smokefree.gov |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-day point prevalence abstinence at 3 months
Reports of no smoking in the 7 days prior to the 3 month assessment. Biochemical verification of abstinence will also be recorded.
Measured: 3 months post baseline
7-day point prevalence abstinence at 6 months
Reports of no smoking in the 7 days prior to the 6 month assessment. Biochemical verification of abstinence will also be recorded.
Measured: 6 months post baseline
7-day point prevalence abstinence at 12 months
Reports of no smoking in the 7 days prior to the 12 month assessment. Biochemical verification of abstinence will also be recorded.
Measured: 12 months post baseline
Secondary outcomes (2)
Reduction in cigarettes smoked by at least 50% between Baseline and each follow-up timepoint
Reduction will be assessed at 3, 6, and 12 month follow-ups.
Measured: 3, 6, and 12 months post baseline
Quit attempts
Quit attempt during the follow-up period at 3, 6, and 12 months post-baseline.
Measured: 3, 6, and 12 month post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2014 (estimated)
- Study startOct 2014
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 501 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Danielle A Ramo, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02207036
- Sponsor's protocol ID
- A119678
- Other IDs
- 5K23DA032578
- Acronym
- TSP
- Status last verified
- May 2017
- First submitted
- 13 May 2014
- Last updated
- 8 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ramo DE, Liu H, Prochaska JJ. A mixed-methods study of young adults' receptivity to using Facebook for smoking cessation: if you build it, will they come? Am J Health Promot. 2015 Mar-Apr;29(4):e126-35. doi: 10.4278/ajhp.130326-QUAL-128. Epub 2014 Feb 27.
PubMed 24575728Ramo DE, Thrul J, Delucchi KL, Ling PM, Hall SM, Prochaska JJ. The Tobacco Status Project (TSP): Study protocol for a randomized controlled trial of a Facebook smoking cessation intervention for young adults. BMC Public Health. 2015 Sep 15;15:897. doi: 10.1186/s12889-015-2217-0.
PubMed 26374203Ramo DE, Thrul J, Chavez K, Delucchi KL, Prochaska JJ. Feasibility and Quit Rates of the Tobacco Status Project: A Facebook Smoking Cessation Intervention for Young Adults. J Med Internet Res. 2015 Dec 31;17(12):e291. doi: 10.2196/jmir.5209.
PubMed 26721211Ramo DE, Rodriguez TM, Chavez K, Sommer MJ, Prochaska JJ. Facebook Recruitment of Young Adult Smokers for a Cessation Trial: Methods, Metrics, and Lessons Learned. Internet Interv. 2014 Apr;1(2):58-64. doi: 10.1016/j.invent.2014.05.001.
PubMed 25045624Ramo DE, Thrul J, Vogel EA, Delucchi K, Prochaska JJ. Multiple Health Risk Behaviors in Young Adult Smokers: Stages of Change and Stability over Time. Ann Behav Med. 2020 Jan 24;54(2):75-86. doi: 10.1093/abm/kaz025.
PubMed 31157881McKelvey K, Ramo D. Conversation Within a Facebook Smoking Cessation Intervention Trial For Young Adults (Tobacco Status Project): Qualitative Analysis. JMIR Form Res. 2018 Sep 4;2(2):e11138. doi: 10.2196/11138.
PubMed 30684432
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Media Intervention for Young Adult Smokers
- ClinicalTrials.gov ID
- NCT02207036
- Acronym / sponsor ID
- TSP / A119678
- Conditions
- Smoking
- Keywords
- Tobacco, cigarettes, cessation, intervention, young adults, Internet, social media, mobile health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 501 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Oct 2014
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 1 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Facebook intervention | Experimental | Behavioral: Facebook interventionAssignment to private group on Facebook with 3 months of content delivered to the group. |
| Referral | Active comparator | Behavioral: Smokefree.govReferral to smokefree.gov website |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Facebook intervention90 days of Facebook messaging, weekly Ask the Doctor sessions | Behavioural | Facebook intervention |
| Smokefree.govreferral to the NCI Smokefree.gov website | Behavioural | Referral |
Primary outcome
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.
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.
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.
2 secondary outcomes
Reduction in cigarettes smoked by at least 50% between Baseline and each follow-up timepoint
Time frame: 3, 6, and 12 months post baseline
Quit attempts
Time frame: 3, 6, and 12 month post-baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2017.
- Background: PubMed 24575728Ramo DE, Liu H, Prochaska JJ. A mixed-methods study of young adults' receptivity to using Facebook for smoking cessation: if you build it, will they come? Am J Health Promot. 2015 Mar-Apr;29(4):e126-35. doi: 10.4278/ajhp.130326-QUAL-128. Epub 2014 Feb 27.
- Background: PubMed 26374203Ramo DE, Thrul J, Delucchi KL, Ling PM, Hall SM, Prochaska JJ. The Tobacco Status Project (TSP): Study protocol for a randomized controlled trial of a Facebook smoking cessation intervention for young adults. BMC Public Health. 2015 Sep 15;15:897. doi: 10.1186/s12889-015-2217-0.
- Background: PubMed 26721211Ramo DE, Thrul J, Chavez K, Delucchi KL, Prochaska JJ. Feasibility and Quit Rates of the Tobacco Status Project: A Facebook Smoking Cessation Intervention for Young Adults. J Med Internet Res. 2015 Dec 31;17(12):e291. doi: 10.2196/jmir.5209.
- Results publication: PubMed 25045624Ramo DE, Rodriguez TM, Chavez K, Sommer MJ, Prochaska JJ. Facebook Recruitment of Young Adult Smokers for a Cessation Trial: Methods, Metrics, and Lessons Learned. Internet Interv. 2014 Apr;1(2):58-64. doi: 10.1016/j.invent.2014.05.001.
- Derived from this study: PubMed 31157881Ramo DE, Thrul J, Vogel EA, Delucchi K, Prochaska JJ. Multiple Health Risk Behaviors in Young Adult Smokers: Stages of Change and Stability over Time. Ann Behav Med. 2020 Jan 24;54(2):75-86. doi: 10.1093/abm/kaz025.
- Derived from this study: PubMed 30684432McKelvey K, Ramo D. Conversation Within a Facebook Smoking Cessation Intervention Trial For Young Adults (Tobacco Status Project): Qualitative Analysis. JMIR Form Res. 2018 Sep 4;2(2):e11138. doi: 10.2196/11138.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danielle A Ramo, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Facebook intervention and Smokefree.gov in people with Smoking, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7-day point prevalence abstinence at 3 months (time frame: 3 months post baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02207036, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2017.