Telehealth versus Self-Directed Lifestyle Intervention to Promote Healthy Blood Pressure: A Protocol for a Randomized Controlled Trial

Introduction: Weight loss, consumption of a Dietary Approaches to Stop Hypertension (DASH) dietary pattern, reduced sodium intake, and increased physical activity have been shown to lower blood pressure. Use of web-based tools and telehealth to deliver lifestyle counseling could be potentially scalable solutions to improve blood pressure through behavioral modification though limited data exists to support these approaches in clinical practice. Methods and analysis: This randomized controlled trial will compare the efficacy of a telehealth versus self-directed lifestyle intervention in lowering 24-hour systolic blood pressure in patients with body mass index [≥] 25 kg/m2 and 24-hour SBP 120-160 mmHg. All participants receive personalized recommendations to improve dietary quality based on a web-based food frequency questionnaire, access to an online comprehensive weight management program, and a smartphone dietary app. The telehealth arm additionally includes weekly calls with registered dietitian nutritionists who use motivational interviewing. The primary outcome is change from baseline to 3-months in 24-hour systolic blood pressure. Secondary outcomes include changes from baseline in Healthy Eating Index-2015 score, weight, waist circumference, and physical activity. Ethics and dissemination: The study has been approved by the Geisinger Institutional Review Board. Results will be disseminated through peer-reviewed publications and conference presentations. Trial registration number: ClinicalTrials.gov Identifier NCT03700710