Actívatexto: Advancing Smoking Cessation and Physical Activity Among Latinos

University of Rochester

Status: Begins enrollment this month

Conditions: Physical Inactivity; Smoking; Smoking Cessation

Treatments: Behavioral: Decídetexto; Behavioral: Actívatexto

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06926608

R01MD019748 (U.S. NIH Grant/Contract)

STUDY00009837

Details and patient eligibility

About

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.

Full 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.

Enrollment: 408 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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408 participants in 2 patient groups

Actívatexto

Experimental group

Description:

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.

Treatment:

Behavioral: Actívatexto

Decídetexto

Active Comparator group

Description:

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.

Treatment:

Behavioral: Decídetexto