Smoking Cessation CounsellingNCT07102290
Pragmatic Trial of Text Messages to Recruit Unassisted Tobacco Users Into Quitline Service
A study testing Free Help, Free Nicotine message and Spanish: Free help message in people with Smoking Cessation Counselling, run by University of California, Davis at 1 site in United States.
Trial summary
The goal of this pragmatic trial is to compare the effects of text messages on quitline enrollment by patients identified in electronic health records as unassisted tobacco users. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation Counselling
- What is being tested?
- Free Help, Free Nicotine message and Spanish: Free help message
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4,171 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2022to 31 Aug 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient of Los Angeles County Department of Health Services with clinical encounter in past 12 months
- 18 years or older
- English or Spanish language
- Had cell phone
- Permission to text
- Patient identified as tobacco user with no documented assistance (e.g., smoking cessation medication, quitline referral, brief counseling by provider) in the prior 24 months
Who cannot join
- Languages other than English or Spanish
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Texting to Recruit Unassisted Tobacco Users at a Large Safety Net Health System Into Quitline Service for a Medicaid Value-based Care Program: Pragmatic Randomized Controlled Trial
The goal of this pragmatic trial is to compare the effects of text messages on quitline enrollment by patients identified in electronic health records as unassisted tobacco users. The main question it aims to answer is:
Do messages offering free counseling or free nicotine patches by text increase quitline enrollment?
Researchers will compare if people receiving texts about free nicotine patches will have higher quitline enrollment than texts about free counseling.
Participants will receive a text message stratified by quitline language and click on the toll-free number to access quitline services.
Read the detailed description
Participants were patients of Los Angeles County Department of Health Services (LADHS). Through the LADHS population health team, eligible patients were identified through data extraction from the electronic health record for quality metric reporting.
Participants were stratified by language (English, Spanish) by LADHS, then randomly assigned to one of two groups. The randomization assignment was generated by a statistician from Kick It California, and text messages were assigned to groups and delivered by LADHS.
Group 1 received a text message offering free quitline coaching. Group 2 received a text message offering free nicotine patches. The texts were sent April-May 2022 and were in English or Spanish according to patient preference. All messages contained a toll-free number to access services, which could be called directly from the text message link, but for tracking purposes different numbers were used.
The quitline, Kick It California, offered coaching to all enrolled participants. The quitline also mailed a 2-week supply of nicotine patches to all enrolled participants unless contraindicated, regardless of which text offer they received. To ensure equitable access, a second text was sent to all participants in June 2022 offering free NRT.
- Conditions
- Smoking Cessation Counselling
- Being tested
- Free Help, Free Nicotine message, Spanish: Free help message, Spanish: Free nicotine message
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free HelpBehavioural
Text message offering free quitline coaching. FREE HELP: Hello #first name#, Kick It California works with your provider to help you quit smoking at no cost. A Quit Coach can double your chances of quitting. For more info call 1-844-XXXXXXX.
Free Nicotine messageBehavioural
Text message for free nicotine patches with free quitline counseling. FREE NRT: Hello #first name#, Kick It California works with your provider to help you quit smoking at no cost. You may be able to get nicotine patches mailed to your home at no cost. For more info call 1-844-XXXXXXX.
Spanish: Free help messageBehavioural
(Spanish translation available as only English text can be published online in clincialtrials.gov): Text message offering free quitline coaching. FREE HELP: Hello #first name#, Kick It California works with your provider to help you quit smoking at no cost. A Quit Coach can double your chances of quitting. For more info call 1-844-XXXXXXX.
Spanish: Free nicotine messageBehavioural
(Spanish translation available as only English text can be published online in clinicaltrials.gov): Text message for free nicotine patches with free quitline counseling. FREE NRT: Hello #first name#, Kick It California works with your provider to help you quit smoking at no cost. You may be able to get nicotine patches mailed to your home at no cost. For more info call 1-844-XXXXXXX.
| Study group | Role | What they receive |
|---|---|---|
| Free counseling text message | Placebo comparator | Usual care of free quitline counseling Receives: Behavioral: Free Help |
| Free nicotine patch text message | Active comparator | Medication incentive offer with free quitline counseling Receives: Behavioral: Free Nicotine message |
| Spanish Arm: Free counseling text message | Placebo comparator | Usual care of free quitline counseling Receives: Behavioral: Spanish: Free help message |
| Spanish Arm: Free nicotine patch message | Active comparator | Medication incentive offer with free quitline counseling Receives: Behavioral: Spanish: Free nicotine message |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calls to the quitline
Proportion of patients (identified as a tobacco user who has not received cessation assistance) calling the quitline from the link in the text message
Measured: 1 month
Secondary outcomes (1)
Receipt of quitline treatment
Proportion of patients (identified as tobacco user who has not received cessation assistance) who called the quitline from a text message and received evidence-based cessation treatments (e.g., quitline coaching, nicotine replacement therapy medication, or both)
Measured: 1-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start1 Apr 2022
- Primary completion1 May 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking Cessation CounsellingStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 4,171 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Kick It California, Los Angeles County Department of Public Health, Tobacco Related Disease Research Program, California Smokers' Helpline
- Responsible party
- Principal investigator, Elisa Tong, MD, University of California, Davis
- Investigators
- Elisa Tong, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07102290
- Sponsor's protocol ID
- 1301241
- Status last verified
- Dec 2025
- First submitted
- 28 Jul 2025
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data about people who engaged with quitline services may be shared if permitted by the quitline protocol, please contact Kick It California
Publications
Valencia CV, Dove MS, Kim K, Giboney P, Yee HF Jr, Kirby CA, Anderson CM, Zhu SH, Tong EK. Texting to Recruit Unassisted Tobacco Users at a Large Safety Net Health System Into Quitline Service for a Medicaid Value-Based Care Program: Pragmatic Randomized Controlled Trial. JMIR Public Health Surveill. 2026 Feb 27;12:e83269. doi: 10.2196/83269.
PubMed 41773565
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Texting to Recruit Unassisted Tobacco Users at a Large Safety Net Health System Into Quitline Service for a Medicaid Value-based Care Program: Pragmatic Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07102290
- Acronym / sponsor ID
- 1301241
- Conditions
- Smoking Cessation Counselling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,171 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Kick It California, Los Angeles County Department of Public Health, Tobacco Related Disease Research Program, California Smokers' Helpline
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 3 Aug 2025 (actual)
- 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.
The goal of this pragmatic trial is to compare the effects of text messages on quitline enrollment by patients identified in electronic health records as unassisted tobacco users. The main question it aims to answer is:
Do messages offering free counseling or free nicotine patches by text increase quitline enrollment?
Researchers will compare if people receiving texts about free nicotine patches will have higher quitline enrollment than texts about free counseling.
Participants will receive a text message stratified by quitline language and click on the toll-free number to access quitline services.
Detailed description
Participants were patients of Los Angeles County Department of Health Services (LADHS). Through the LADHS population health team, eligible patients were identified through data extraction from the electronic health record for quality metric reporting.
Participants were stratified by language (English, Spanish) by LADHS, then randomly assigned to one of two groups. The randomization assignment was generated by a statistician from Kick It California, and text messages were assigned to groups and delivered by LADHS.
Group 1 received a text message offering free quitline coaching. Group 2 received a text message offering free nicotine patches. The texts were sent April-May 2022 and were in English or Spanish according to patient preference. All messages contained a toll-free number to access services, which could be called directly from the text message link, but for tracking purposes different numbers were used.
The quitline, Kick It California, offered coaching to all enrolled participants. The quitline also mailed a 2-week supply of nicotine patches to all enrolled participants unless contraindicated, regardless of which text offer they received. To ensure equitable access, a second text was sent to all participants in June 2022 offering free NRT.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Free counseling text message | Placebo comparator | Behavioral: Free HelpUsual care of free quitline counseling |
| Free nicotine patch text message | Active comparator | Behavioral: Free Nicotine messageMedication incentive offer with free quitline counseling |
| Spanish Arm: Free counseling text message | Placebo comparator | Behavioral: Spanish: Free help messageUsual care of free quitline counseling |
| Spanish Arm: Free nicotine patch message | Active comparator | Behavioral: Spanish: Free nicotine messageMedication incentive offer with free quitline counseling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient of Los Angeles County Department of Health Services with clinical encounter in past 12 months
- 18 years or older
- English or Spanish language
- Had cell phone
- Permission to text
Key exclusion criteria (1 listed)
- Languages other than English or Spanish
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 |
|---|---|---|
| Free HelpText message offering free quitline coaching. FREE HELP: Hello #first name#, Kick It California works with your provider to help you quit smoking at no cost. A Quit Coach can double your chances of quitting. For more info call 1-844-XXXXXXX. | Behavioural | Free counseling text message |
| Free Nicotine messageText message for free nicotine patches with free quitline counseling. FREE NRT: Hello #first name#, Kick It California works with your provider to help you quit smoking at no cost. You may be able to get nicotine patches mailed to your home at no cost. For more info call 1-844-XXXXXXX. | Behavioural | Free nicotine patch text message |
| Spanish: Free help message(Spanish translation available as only English text can be published online in clincialtrials.gov): Text message offering free quitline coaching. FREE HELP: Hello #first name#, Kick It California works with your provider to help you quit smoking at no cost. A Quit Coach can double your chances of quitting. For more info call 1-844-XXXXXXX. | Behavioural | Spanish Arm: Free counseling text message |
| Spanish: Free nicotine message(Spanish translation available as only English text can be published online in clinicaltrials.gov): Text message for free nicotine patches with free quitline counseling. FREE NRT: Hello #first name#, Kick It California works with your provider to help you quit smoking at no cost. You may be able to get nicotine patches mailed to your home at no cost. For more info call 1-844-XXXXXXX. | Behavioural | Spanish Arm: Free nicotine patch message |
Primary outcome
Calls to the quitline
Time frame: 1 month
Proportion of patients (identified as a tobacco user who has not received cessation assistance) calling the quitline from the link in the text message
1 secondary outcome
Receipt of quitline treatment
Time frame: 1-3 months
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 15 Dec 2025.
- Derived from this study: PubMed 41773565Valencia CV, Dove MS, Kim K, Giboney P, Yee HF Jr, Kirby CA, Anderson CM, Zhu SH, Tong EK. Texting to Recruit Unassisted Tobacco Users at a Large Safety Net Health System Into Quitline Service for a Medicaid Value-Based Care Program: Pragmatic Randomized Controlled Trial. JMIR Public Health Surveill. 2026 Feb 27;12:e83269. doi: 10.2196/83269.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data about people who engaged with quitline services may be shared if permitted by the quitline protocol, please contact Kick It California
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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.
Elisa Tong, MD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Free Help, Free Nicotine message and Spanish: Free help message in people with Smoking Cessation Counselling, run by University of California, Davis 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 6 inclusion and 1 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 15 Dec 2025. 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. Some participants in this study may receive a placebo. 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?
Calls to the quitline (time frame: 1 month). 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 NCT07102290, which also lists 1 linked publication.
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 15 Dec 2025.