Pasos Hacia La Salud II: study protocol for a randomized controlled trial of a theory- and technology-enhanced physical activity intervention for Latina women, compared to the original intervention

Abstract

Background Latinas are at increased risk for many lifestyle-related chronic diseases and are one of the least physically active populations in the US Innovative strategies are needed to help Latinas achieve the health benefits associated with physical activity (PA). This manuscript describes the study protocol of the Pasos Hacia La Salud II Study, which builds upon our previous research to test an enhanced individually-tailored, text-message and website-delivered, Spanish-language intervention (enhanced intervention), in comparison to the original web-based Pasos Hacia La Salud Intervention (original intervention). Methods Sedentary Latinas between the ages of 18–65 will be recruited and will complete an orientation and baseline assessments. Participants will be subsequently randomized to the original intervention, or the Enhanced Intervention, which has greater targeting of theoretical constructs such as self-efficacy, enjoyment, and social support, and which uses text messages and more dynamic and refined website features to encourage increased website use. Using a linear mixed effects regression model, we will simultaneously estimate the intervention effects on mean accelerometer-measured hours/week of moderate-to-vigorous PA (MVPA) at 6, 12, 18, and 24 months, with a subject-specific intercept (intent-to-treat sample). Change in self-reported MVPA, measured via the 7-day Physical Activity Recall, will be assessed as a secondary outcome using a similar model. We will investigate potential mediators of the intervention effect using a multiple mediation approach, and potential moderators by evaluating potential interactions. As an exploratory outcome, we will study the differences (among both study arms) in cost, in US dollars, per minute increases in weekly mean MVPA. Discussion The original Pasos PA intervention showed efficacy in helping Latinas increase PA; we expect the Enhanced Intervention to help a larger proportion of participants to increase and maintain their PA long term. This web- and text-based enhanced intervention could have great reach and dissemination potential, which could be capitalized on in the future to help to advance health equity. Adaptations made in response to the COVID-19 pandemic are also described in this manuscript. Trial registration Clinical Trial Number: NCT03491592. First posted April 9, 2018.

Six-Month Outcomes of a Theory- and Technology-Enhanced Physical Activity Intervention for Latina Women (Pasos Hacia La Salud II): Randomized Controlled Trial

“…All study procedures were approved by the Brown University Institutional Review Board (IRB#: 00000556) and described in detail in a prior report [ 21 ]. All participants provided written informed consent.…”

“…Web-based tools to help participants increase their MVPA include (1) self-monitoring of behavior (eg, calendars to log weekly activity), (2) discrepancy between current behavior and goal (eg, calendars display weekly goals alongside weekly activity), (3) social support (eg, a discussion board where participants can interact), (4) instruction about how to be physically active (eg, information about local PA resources and places to be active), (5) problem solving (eg, tips for overcoming common PA barriers; neighborhood safety, and caregiving responsibilities), (6) motivational stage-matched PA manuals based on the TTM [ 17 , 22 ], and (7) individually tailored feedback based on their responses to online questionnaires assessing self-efficacy for PA, processes of change for PA, and social support. Further details about the tailored intervention content are described elsewhere [ 21 ]. Participants are encouraged by staff to regularly access the website, log their PA on the website, and receive a tip of the week.…”

“…All analyses were based on the intent to treat the sample, with all randomized participants included in the analysis. Details about power analyses conducted to determine the sample size are reported elsewhere [ 21 ]. Generalized linear models use a quasi-likelihood-based approach to estimation thus making use of all available data (intent-to-treat sample) without directly imputing missing values.…”

“…This study builds upon our previous intervention and formative research with Latina women to test the original individually tailored, Spanish-language, web-based Pasos Hacia La Salud Intervention (original intervention) to a text-message and theory-enhanced version (enhanced intervention) [ 14 , 19 ]. This paper aims to evaluate changes in moderate to vigorous physical activity (MVPA) in the original versus enhanced conditions from baseline to 6 months, as described in this study’s protocol paper [ 21 ]. A secondary aim of this paper is to explore differences in activity increases in individuals in the contemplation stage versus the action transtheoretical model (TTM) [ 22 ] stage of change at baseline; that is, to compare individuals who were doing no activity (0 min/wk) to those doing some amount of activity (>0 min/wk), to better understand who is best aided by the enhancements.…”