Telehealth versus self-directed lifestyle intervention to promote healthy blood pressure: a protocol for a randomised 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/m 2 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 WHO Trial Registration Data Set Primary registry and trial identifying number: ClinicalTrials.gov Identifier NCT03700710 Date of registration in Primary Registry: 10/9/2018 Secondary identifying numbers: N/A Source of Monetary or Material Support: Geisinger Health Plan Primary Sponsor: Geisinger Clinic Secondary Sponsors: None Contact for Public Queries: Christina Yule; 570-214-5233; cmyule@geisinger.edu Contact for Scientific Queries: Alex R. Chang, MD, MS; Kidney Health Research Institute; Geisinger; 100 N Academy Ave, Danville, PA; 570-271-8026; achang@geisinger.edu Public title: Remote Dietary Counseling to Promote Healthy Diet and Blood Pressure Scientific title: Remote Dietary Counseling to Promote Healthy Diet and Blood Pressure Countries of recruitment: USA Health conditions studied: high blood pressure Interventions: Active Comparator: Self-Guided Approach In the self-guided arm, participants will receive access to web-based tools to help achieve healthy lifestyle changes to lower their blood pressure. The web-based tools include: 1) a web-based food frequency questionnaire (Viocare FFQ), which will provide a snapshot of participants’ dietary habits in the past 6 months as well as personalized recommendations for areas to improve; 2) access to BMIQ ( www.bmiq.com ), an evidence-based program developed by Dr. Louis Aronne at Columbia University, which includes program materials for weight loss and leading a healthy lifestyle; 3) LoseIt ( www.loseit.com ), a meal-logging app that integrates seamlessly with the BMIQ website. Experimental: Dietitian-led Approach In the dietitian-led arm, dietitian will use motivational interviewing in 15-30 minute telephone calls with participants. The BMIQ website will be used to share participant dietary data (LoseIt) and weight data with dietitians. Participants will receive access to web-based tools to help achieve healthy lifestyle changes to lower their blood pressure. The web-based tools include: 1) a web-based food frequency questionnaire (Viocare FFQ), which will provide a snapshot of participants’ dietary habits in the past 6 months as well as personalized recommendations for areas to improve; 2) access to BMIQ; 3) LoseIt ( www.loseit.com ), a meal-logging app that integrates seamlessly with the BMIQ website. Key Inclusion and Exclusion Criteria Inclusion Criteria: 24-hour ambulatory SBP 120-160 mmHg, BMI ≥ 25 kg/m2, access to a telephone, access to a computer or smartphone with internet access, complete dietary data entry using LoseIt for at least 5 out of 7 days during run-in period, enter weight into the BMIQ portal during run-in period Exclusion Criteria: inability to understand English, myocardial infarction, stroke, or atherosclerotic cardiovascular disease procedure within last 6 months, current treatment for malignancy, planned or previous bariatric surgery, pregnant, breast-feeding, or planned pregnancy prior to the end of participation, self-reported average consumption of > 21 alcoholic beverages per week or binge drinking, psychiatric hospitalization in past year, current symptoms of angina, planning to leave the area prior to end of the study, current participation in another clinical trial, principal investigator discretion (i.e. concerns about safety, compliance) Study type: randomized, parallel-arm, interventional study; study staff assessing outcomes and statistical analysis are masked. Purpose is to compare the efficacy of a self-guided vs. a telehealth dietitian-led approach to lower blood pressure through lifestyle modification. Date of first enrollment – 1/16/19 Sample size – 200 Recruitment status – recruiting