Rationale: Swipe out Stroke (SOS) examines the use of a smartphone-based mobile application to reduce obesity in high-risk minority stroke patients. At record-high levels in the United States, obesity disproportionately affects minorities and is highly correlated with cerebrovascular disease. Unfortunately, structured weight loss programs are expensive, and compliance significantly decreases upon program completion. Mobile health (mHealth) technology is an innovative, cost-effective way to bridge this gap. Minorities spend over 4.5 billion dollars annually on consumer electronics, making studies that utilize mHealth applications ideal for health promotion and disease prevention.
Aims and design: SOS is a prospective, randomized-controlled trial with open blinded endpoint comparing an mHealth based dietary intervention to usual care to facilitate weight reduction. Ischemic and hemorrhagic stroke survivors and their carers are recruited from the acute care service of a Houston-based comprehensive stroke center. A neurorehabilitation physician or vascular neurologist meets with participants during the index hospitalization, a baseline clinic visit, followed by visits at 1, 3, and 6 month intervals. The SOS Team focuses on feasible modifications to the Southern dietary pattern (fried foods, fatty foods, added fats, eggs, processed meats, such as bacon and ham, organ meats (e.g., liver), and sweetened drinks) and caloric restriction to facilitate a 5% reduction in total body weight. Practical barriers to adherence are addressed, such as access to transportation, financial limitations, and depression.
Study outcomes: The primary dependent measure is a reduction of total body weight. Secondary outcomes include systolic blood pressure, hemoglobin A1c, low-density lipoprotein, triglycerides, and Factor VIII.
Conclusion: SOS will determine whether a Phase III effectiveness trial of a smartphone-based mobile application to address obesity-related health disparities is warranted throughout the Southeastern United States (Stroke Belt).
Keywords: Clinical trials; healthcare disparities; mobile health technology; obesity; patient adherence; patient compliance; smartphone applications; stroke prevention.
© 2016 World Stroke Organization.