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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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