Actívatexto for Smoking Cessation

Overseen By Francisco Cartujano, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Rochester

Must be taking: Nicotine replacement

Disqualifiers: Pregnancy, Other tobacco use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 6 months

408 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new mobile intervention called Actívatexto, designed to help Latino adults quit smoking and become more active. Participants will receive supportive text messages, wear devices that track physical activity, and use nicotine replacement therapies. The trial compares this comprehensive program to another that focuses solely on quitting smoking. Ideal candidates are Latino adults who smoke at least three days a week, wish to quit in the next month, and are open to increasing physical activity. Participants need a cellphone for text messaging and must be willing to wear a fitness tracker daily. As an unphased trial, this study provides a unique opportunity to explore innovative ways to improve health and wellness.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, since the trial includes nicotine replacement therapies, it's best to discuss your current medications with the research team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Actívatexto is generally safe and well-received. In one study, 70% of participants successfully quit smoking after three months, indicating effective use of the program without major problems. The program includes text messages, devices to track physical activity, and nicotine replacement therapies (NRT). The FDA has already approved NRT to help people quit smoking, confirming its safety. Participants reported frequent use of NRT and increased physical activity, which are positive signs of involvement without serious side effects. Overall, the components of Actívatexto, including the well-known NRT, have demonstrated promising safety results for those who have tried them. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for smoking cessation focus solely on helping people quit smoking, often using nicotine replacement therapies like patches or gum. Actívatexto is unique because it combines smoking cessation support with a boost in physical activity through a mobile intervention. This approach includes a text messaging program that encourages both quitting smoking and being active, wearable fitness trackers, and an online dashboard for tracking progress. Researchers are excited about Actívatexto because integrating physical activity might enhance overall health while supporting smoking cessation, offering a more holistic approach than traditional methods.

What evidence suggests that this trial's treatments could be effective for smoking cessation?

Research has shown that Actívatexto, one of the treatments in this trial, may help people quit smoking. In one study, 70% of participants stopped smoking after three months. Another study found that 40% of users quit by the end of 12 weeks, with a 50% overall reduction in smoking. Actívatexto combines text messages, wearable devices, and nicotine replacement therapies to aid smoking cessation and encourage physical activity. These promising results suggest Actívatexto could be effective for those wanting to quit smoking and improve their physical activity. Meanwhile, Decídetexto, another treatment option in this trial, focuses solely on smoking cessation through text messages and nicotine replacement therapies. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for Latino adults who smoke and are looking to quit, while also aiming to increase their physical activity. Participants should be comfortable using mobile interventions like text messaging programs and wearable devices.

Inclusion Criteria

Smoke cigarettes at least 3 days per week

I can read and speak English or Spanish.

I want to quit smoking within the next month.

Exclusion Criteria

Use of tobacco products other than cigarettes in the past 30 days (including e-cigarettes)

I cannot increase my physical activity or undergo a fitness evaluation.

Being pregnant or breastfeeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete a baseline assessment at enrollment

1 week

1 visit (in-person or virtual)

Treatment

Participants receive the Actívatexto or Decídetexto mobile intervention, nicotine replacement therapies, and a Fitbit Versa 4 device

6 months

Monthly virtual check-ins

Follow-up

Participants are monitored for smoking cessation and physical activity outcomes

6 months

Follow-up assessments at Months 3 and 6

What Are the Treatments Tested in This Trial?

Interventions

• Actívatexto
• Decídetexto

Trial Overview The study tests Actívatexto, a program combining text messages promoting smoking cessation and exercise, with wearable tech for tracking activity, nicotine replacement therapies (NRT), and an online dashboard for data management by researchers.

How Is the Trial Designed?

Group I: Actívatexto Experimental Treatment 1 Intervention

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.

Group II: Decídetexto Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Hackensack Meridian Health

Collaborator

Trials

141

Recruited

42,900+

Published Research Related to This Trial

Smoking is the leading cause of premature death in Western countries, highlighting the urgent need for effective cessation methods to help smokers quit early.

Current and emerging therapies, including novel medications and vaccines, show promise in improving the efficacy and safety of smoking cessation treatments, with many in advanced stages of development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking cessation: present status and future perspectives. Caponnetto, P., Russo, C., Polosa, R.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11000686/

Actívatexto: Feasibility and Acceptability of a Mobile ... The 70% smoking cessation rate seen at month 3 is extremely promising. A previous feasibility study of a mobile intervention that solely promote ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06926608

Study Details | NCT06926608 | Actívatexto: Advancing ... 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) ...

3. researchgate.net researchgate.net/publication/379680895_Activatexto_Feasibility_and_Acceptability_of_a_Mobile_Intervention_That_Promotes_Smoking_Cessation_and_Physical_Activity_among_Latinos

(PDF) Actívatexto: Feasibility and Acceptability of a Mobile ... Results Sixteen (40%) participants quit by the end of 12 weeks. For the whole sample, we observed an overall, sustained 50% reduction in smoking ...

4. withpower.com withpower.com/trial/actvatexto-for-smoking-cessation-6b888

Actívatexto for Smoking Cessation 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) ...

5. reporter.nih.gov reporter.nih.gov/project-details/11196069

Actívatexto: Advancing smoking cessation and ... - NIH RePORTER Pilot tested among Latinos who smoke and do not meet the recommended levels of physical activity (n=20), Actívatexto generated high satisfaction, increased ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38592449/

Feasibility and Acceptability of a Mobile Intervention That ... Actívatexto resulted in a noteworthy cessation rate at month 3 (70%), increased mean weekly minutes of MVPA, produced high use of NRT, ...