Clinical trial NCT06926608: Actívatexto: Advancing Smoking Cessation and Physical Activity Among Latinos
Official title: Actívatexto: Advancing Smoking Cessation and Physical Activity Among Latinos
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Smoking
Smoking Cessation
Physical Inactivity
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
name: Hackensack Meridian Health
First posted: 2025-04-13
Enrollment: 408
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percent of participants with cotinine verified 7-day point prevalence abstinence
timeFrame: Month 6
Secondary outcomes:
measure: Percent of participants with self-reported 7-day point prevalence abstinence
timeFrame: Month 6
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
References: