Actívatexto: Advancing Smoking Cessation and Physical Activity Among Latinos

NCT ID: NCT06926608

Last Updated: 2025-07-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 408 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-17
• Study Completion Date: 2029-05-31

Brief 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. 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Actívatexto

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 Type: EXPERIMENTAL

Actívatexto

Intervention Type: BEHAVIORAL

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.

Decídetexto

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.

Group Type: ACTIVE_COMPARATOR

Decídetexto

Intervention Type: BEHAVIORAL

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.

Interventions

Actívatexto

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.

Intervention Type: BEHAVIORAL

Decídetexto

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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
• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

Hackensack Meridian Health

OTHER

Sponsor Role: collaborator

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Francisco Cartujano, MD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Rochester Medical Center

Rochester, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Francisco Cartujano, MD

Role: CONTACT

francisco_cartujano@urmc.rochester.edu

(585) 273-1646

Facility Contacts

Francisco Cartujano, MD

Role: primary

francisco_cartujano@urmc.rochester.edu

585-353-0035

Other Identifiers

R01MD019748

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00009837

Identifier Type: -

Identifier Source: org_study_id