SmokingNCT06926608
Actívatexto: Advancing Smoking Cessation and Physical Activity Among Latinos
A study testing Actívatexto and Decídetexto in people with Smoking and Smoking Cessation, run by University of Rochester at 1 site in United States.
Trial summary
The purpose of this randomized controlled trial is to assess the efficacy of Actívatexto (Aim 1) and the mediators of the presumed treatment effect (Aim 2) among Latino adults who smoke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking, Smoking Cessation, Physical Inactivity
- What is being tested?
- Actívatexto and Decídetexto
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 408 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jun 2025to 31 May 2029
- Phase
- Interventional
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
- Self-identify as Hispanic and/or Latino
- Know how to read and speak English and/or Spanish
- Be ≥ 18 years of age
- Not meet the recommended levels of physical activity (150 minutes of moderate to vigorous physical activity)
- Smoke cigarettes at least 3 days per week
- Be interested in quitting smoking in the next 30 days
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- Have a cellphone with text messaging capability
- Know how to utilize text messages
- Be willing to wear a wearable device daily to monitor physical activity
- Be willing to complete all study visits
Who cannot join
- Use of tobacco products other than cigarettes in the past 30 days (including e-cigarettes)
- Being pregnant or breastfeeding
- Plan to move from their current residence in the next six months
- Another household member enrolled in the study
- Unable to become more physically active or engage in a fitness appraisal
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Rochester Medical Center
Rochester, New York, 14642
Francisco Cartujano, MD, 585-353-0035, francisco_cartujano@urmc.rochester.edu
About this study
The purpose of this randomized controlled trial is to assess the efficacy of Actívatexto (Aim 1) and the mediators of the presumed treatment effect (Aim 2) among Latino adults who smoke. Actívatexto is a mobile intervention that integrates four components: 1) a text messaging program that promotes both smoking cessation and physical activity, 2) wearable devices to monitor physical activity, 3) smoking cessation pharmacotherapy [i.e., nicotine replacement therapies (NRT)], and 4) an online dashboard where the research team manages participants' incoming and outgoing data from both the text messaging program and wearable devices.
Read the detailed description
We will conduct a two-arm randomized controlled trial among Latinos who smoke and do not meet the recommended levels of physical activity (N=408). Participants will be recruited via community-based efforts and randomly assigned in a 1:1 ratio to Actívatexto (a mobile intervention that promotes both smoking cessation and physical activity) or Decídetexto (a mobile intervention that solely promotes smoking cessation). All participants will be provided with nicotine replacement therapies and a Fitbit Versa 4 device. Participants in both groups will complete a baseline assessment at enrollment and follow-up assessments at Months 3 and 6.
- Conditions
- Smoking, Smoking Cessation, Physical Inactivity
- Being tested
- Actívatexto, Decídetexto
- Medical subject headings
- Smoking, Smoking Cessation, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActívatextoBehavioural
Actívatexto is a mobile intervention that promotes both smoking cessation and physical activity. Actívatexto integrates four components: 1) a text messaging program that promotes both smoking cessation and physical activity, 2) wearable devices to monitor physical activity, 3) smoking cessation pharmacotherapy (i.e., nicotine replacement therapies), and 4) an online dashboard where the research team manages participants' incoming and outgoing data from both the text messaging program and wearable devices.
DecídetextoBehavioural
Decídetexto is a mobile intervention that solely promotes smoking cessation. Decídetexto integrates three components: 1) a text messaging program that solely promotes smoking cessation, 2) smoking cessation pharmacotherapy (i.e., nicotine replacement therapies), and 3) an online dashboard where the research team manages participants' incoming and outgoing data from the text messaging program.
| Study group | Role | What they receive |
|---|---|---|
| Actívatexto | Experimental | Actívatexto is a mobile intervention that promotes both smoking cessation and physical activity. Actívatexto integrates four components: 1) a text messaging program that promotes both smoking cessation and physical activity, 2) wearable devices to monitor physical activity, 3) smoking cessation pharmacotherapy (i.e., nicotine replacement therapies), and 4) an online dashboard where the research team manages participants' incoming and outgoing data from both the text messaging program and wearable devices. Receives: Behavioral: Actívatexto |
| Decídetexto | Active comparator | Decídetexto is a mobile intervention that solely promotes smoking cessation. Decídetexto integrates three components: 1) a text messaging program that solely promotes smoking cessation, 2) smoking cessation pharmacotherapy (i.e., nicotine replacement therapies), and 3) an online dashboard where the research team manages participants' incoming and outgoing data from the text messaging program. Receives: Behavioral: Decídetexto |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of participants with cotinine verified 7-day point prevalence abstinence
Cotinine levels ≤15 ng/mL in saliva
Measured: Month 6
Secondary outcomes (1)
Percent of participants with self-reported 7-day point prevalence abstinence
No cigarettes, "not even a puff", in the past 7 days
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2025
- Study start17 Jun 2025
- Primary completion31 May 2029 (estimated)
- Study completion31 May 2029 (estimated)
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 SmokingStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 408 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), Hackensack Meridian Health
- Responsible party
- Principal investigator, Francisco Cartujano, MD, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06926608
- Sponsor's protocol ID
- STUDY00009837
- Other IDs
- R01MD019748
- Status last verified
- Sep 2026
- First submitted
- 10 Apr 2025
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ramos Santiago JW, Orfin RH, Lara D, Uceda V, Hurtado-de-Mendoza A, Chavez-Iniguez A, Fuller D, Bermudez D, Marquez DX, Ossip DJ, Li D, DeJesus E, Vasquez E, Carter-Bawa L, Yousefi-Nooraie R, McIntosh S, Cupertino AP, Cartujano-Barrera F. Activatexto: Advancing smoking cessation and physical activity among Latino adults. Study protocol for a randomized clinical trial. Contemp Clin Trials. 2026 Oct 5;170:108491. doi: 10.1016/j.cct.2026.108491. Online ahead of print.
PubMed 42833471