Actívatexto: Advancing Smoking Cessation and Physical Activity Among Latinos
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Actívatexto, Decídetexto.
- Who it may be relevant to
- Registry conditions: Smoking, Smoking Cessation, Physical Inactivity. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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 wearabl - 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.
Primary outcome measures
- Percent of participants with cotinine verified 7-day point prevalence abstinence [Time frame: Month 6]
Secondary outcome measures (1)
- Percent of participants with self-reported 7-day point prevalence abstinence [Time frame: Month 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Rochester Medical Center — Rochester
Identifiers
NCT: NCT06926608 · STUDY00009837 · R01MD019748