Actívatexto: Advancing Smoking Cessation and Physical Activity Among Latinos

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.

Study Overview

• Status: Recruiting
• Conditions: Smoking; Smoking Cessation; Physical Inactivity
• Intervention / Treatment: Behavioral: Actívatexto; Behavioral: Decídetexto

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.

• Study Type: Interventional
• Enrollment (Estimated): 408
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Francisco Cartujano, MD; Phone Number: (585) 273-1646; Email: francisco_cartujano@urmc.rochester.edu

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • Recruiting
      • University of Rochester Medical Center
      • Contact: Francisco Cartujano, MD; Phone Number: 585-353-0035; Email: francisco_cartujano@urmc.rochester.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of participants with cotinine verified 7-day point prevalence abstinence	Cotinine levels ≤15 ng/mL in saliva	Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of participants with self-reported 7-day point prevalence abstinence	No cigarettes, "not even a puff", in the past 7 days	Month 6

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD); Hackensack Meridian Health

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2025
• Primary Completion (Estimated): May 31, 2029
• Study Completion (Estimated): May 31, 2029

Study Registration Dates

• First Submitted: April 10, 2025
• First Submitted That Met QC Criteria: April 10, 2025
• First Posted (Actual): April 13, 2025

Study Record Updates

• Last Update Posted (Estimated): July 8, 2025
• Last Update Submitted That Met QC Criteria: July 3, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00009837; R01MD019748 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No