Actívatexto: Advancing Smoking Cessation and Physical Activity Among Latinos

Not Applicable

Not yet recruiting

• Conditions: Smoking; Smoking Cessation; Physical Inactivity

• Registration Number: NCT06926608
• Lead Sponsor: University of Rochester

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.

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-10
• Study First Submitted QC: 2025-04-10
• Last Update Submitted: 2025-04-10
• Study First Posted: 2025-04-13
• Last Update Posted: 2025-04-13
• Study Start: 2025-06-02
• Primary Completion: 2029-05-31
• Study Completion: 2029-05-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 408

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States