Physical Inactivity, Smoking, Smoking Cessation
Conditions
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.
Interventions
BEHAVIORALActívatexto
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.
BEHAVIORALDecídetexto
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.
Sponsors
University of Rochester
National Institute on Minority Health and Health Disparities (NIMHD)
Hackensack Meridian Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of participants with cotinine verified 7-day point prevalence abstinence | Month 6 | Cotinine levels ≤15 ng/mL in saliva |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of participants with self-reported 7-day point prevalence abstinence | Month 6 | No cigarettes, "not even a puff", in the past 7 days |
Countries
United States
Contacts
CONTACTFrancisco Cartujano, MD
Outcome results
None listed