The Hombres Saludables Physical Activity Web-Based and Mobile Phone Intervention: Pilot Randomized Controlled Trial With Latino Men.

BACKGROUND: Owing to structural-level, interpersonal-level, and individual-level barriers, Latino men have disproportionately high rates of physical inactivity and experience related chronic diseases. Despite these disparities, few physical activity (PA) interventions are culturally targeted for Latino men. OBJECTIVE: This study reported the feasibility and acceptability of Hombres Saludables PA intervention for Latino men. We also reported the preliminary efficacy of the intervention on PA change and provided the results of the exploratory moderator and mediator analysis. METHODS: We completed a 6-month, single-blind, pilot randomized controlled trial of Hombres Saludables with Latino men aged between 18 and 65 years. Men were randomized to either (1) a theory-driven, individually tailored, internet-based and SMS text message-based, Spanish-language PA intervention arm or (2) a nutrition and wellness attention contact control arm that was also delivered via the web and SMS text message. We assessed the primary study outcomes of feasibility using participant retention and acceptability using postintervention survey and open-ended interview questions. We measured the preliminary efficacy via change in minutes of moderate to vigorous PA per week using ActiGraph wGT3X-BT accelerometry (primary measure) and self-reported minutes per week using 7-day Physical Activity Recall. Participants completed the assessments at study enrollment and after 6 months. RESULTS: The 38 participants were predominantly Dominican (n=8, 21%) or Guatemalan (n=5, 13%), and the mean age was 38.6 (SD 12.43) years. Retention rates were 91% (21/23) for the PA intervention arm and 100% (15/15) for the control arm. Overall, 95% (19/20) of the intervention arm participants reported that the Hombres study was somewhat to very helpful in getting them to be more physically active. Accelerometry results indicated that participants in the intervention group increased their PA from a median of 13 minutes per week at study enrollment to 34 minutes per week at 6 months, whereas the control group participants showed no increases. On the basis of self-reports, the intervention group was more likely to meet the US PA guidelines of 150 minutes per week of moderate to vigorous PA at 6-month follow-up, with 42% (8/19) of the intervention participants meeting the PA guidelines versus 27% (4/15) of the control participants (odds ratio 3.22, 95% CI 0.95-13.69). Exploratory analyses suggested conditional effects on PA outcomes based on baseline stage of motivational readiness, employment, and neighborhood safety. CONCLUSIONS: The PA intervention demonstrated feasibility and acceptability. Results of this pilot study indicate that the Hombres Saludables intervention is promising for increasing PA in Latino men and suggest that a fully powered trial is warranted. Our technology-based PA intervention provides a potentially scalable approach that can improve health in a population that is disproportionately affected by low PA and related chronic disease. TRIAL REGISTRATION: ClinicalTrials.gov NCT03196570; https://classic.clinicaltrials.gov/ct2/show/NCT03196570. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/23690.

A Tailored Web- and Text-Based Intervention to Increase Physical Activity for Latino Men: Protocol for a Randomized Controlled Feasibility Trial.

BACKGROUND: Latino men in the United States report low physical activity (PA) levels and related health conditions (eg, diabetes and obesity). Engaging in regular PA can reduce the risk of chronic diseases and yield many health benefits; however, there is a paucity of interventions developed exclusively for Latino men. OBJECTIVE: To address the need for culturally relevant PA interventions, this study aims to develop and evaluate Hombres Saludables, a 6-month theory-based, tailored web- and text message-based PA intervention in Spanish for Latino men. This protocol paper describes the study design, intervention, and evaluation methods for Hombres Saludables. METHODS: Latino men aged 18-65 years were randomized to either the individually tailored PA internet intervention arm or the nutrition and wellness internet control arm. The PA intervention included 2 check-in phone calls; automated SMS text messages; a pedometer; a 6-month gym membership; access to a private Facebook group; and an interactive website with PA tracking, goal setting, and individually tailored PA content. The primary outcomes were feasibility, acceptability, and efficacy (minutes per week of total moderate-to-vigorous PA assessed via the ActiGraph GT3X+ accelerometer worn at the waist and 7-day physical activity recall at baseline and 6 months). Secondary outcomes examined potential moderators (eg, demographics, acculturation, and environmental variables) and mediators (eg, self-efficacy and cognitive and behavioral processes of change) of treatment effects at 6 months post randomization. RESULTS: This study was funded in September 2016. Initial institutional review board approval was received in February 2017, and focus groups and intervention development were conducted from April 2017 to January 2018. Recruitment for the clinical trial was carried out from February 2018 to July 2019. Baseline data collection was carried out from February 2018 to October 2019, with a total of 43 participants randomized. Follow-up data were collected through April 2020. Data cleaning and analysis are ongoing. CONCLUSIONS: We developed and tested protocols for a highly accessible, culturally and linguistically relevant, theory-driven PA intervention for Latino men. Hombres Saludables used an innovative, interactive, web- and text message-based intervention for improving PA among Latino men, an underserved population at risk of low PA and related chronic disease. If the intervention demonstrates feasibility, acceptability, and preliminary efficacy, we will refine and evaluate it in a larger randomized control trial. TRIAL REGISTRATION: Clinicaltrials.gov: NCT03196570; https://clinicaltrials.gov/ct2/show/NCT03196570. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/23690.