Actívatexto: Advancing Smoking Cessation and Physical Activity Among Latinos

NCT06926608 | Recruiting DMC

• 2 other identifiers: STUDY00009837R01MD019748
• Study Type: interventional
• Target: 408
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking; Smoking Cessation; Physical Inactivity

Outcome Measures

Primary Outcomes (1)

• Percent of participants with cotinine verified 7-day point prevalence abstinence

  Cotinine levels ≤15 ng/mL in saliva

  Month 6

Secondary Outcomes (1)

• Percent of participants with self-reported 7-day point prevalence abstinence

  Month 6

Study Arms (2)

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.

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.

Behavioral: Decídetexto

Interventions

Actívatexto 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.

Actívatexto

Decídetexto 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.

Decídetexto

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator
• Hackensack Meridian Health: collaborator

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

RECRUITING

MeSH Terms

Conditions

Smoking; Smoking Cessation; Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior; Health Behavior

Central Study Contacts

Francisco Cartujano, MD

CONTACT

(585) 273-1646; francisco_cartujano@urmc.rochester.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: April 13, 2025
• Study Start: June 17, 2025
• Primary Completion (Estimated): May 31, 2029
• Study Completion (Estimated): May 31, 2029
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)