Telehealth versus Self-Directed Lifestyle Intervention to Promote Healthy Blood Pressure: A Protocol for a Randomized Controlled Trial
Authors: Taher Mohamed , Yule Christina , Bonaparte Heather , Kwiecien Sara , Collins Charlotte , Naylor Allison , Juraschek Stephen P , Bailey-Davis Lisa , Chang Alex R 
Published: September 2020

AbstractIntroductionWeight 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 analysisThis 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 disseminationThe study has been approved by the Geisinger Institutional Review Board. Results will be disseminated through peer-reviewed publications and conference presentations.Trial registration numberClinicalTrials.gov Identifier NCT03700710WHO Trial Registration Data SetPrimary registry and trial identifying number: ClinicalTrials.gov Identifier NCT03700710Date of registration in Primary Registry: 10/9/2018Secondary identifying numbers: N/ASource of Monetary or Material Support: Geisinger Health PlanPrimary Sponsor: Geisinger ClinicSecondary Sponsors: NoneContact for Public Queries: Christina Yule; 570-214-5233; cmyule@geisinger.eduContact for Scientific Queries: Alex R. Chang, MD, MS; Kidney Health Research Institute; Geisinger; 100 N Academy Ave, Danville, PA; 570-271-8026; achang@geisinger.eduPublic title: Remote Dietary Counseling to Promote Healthy Diet and Blood PressureScientific title: Remote Dietary Counseling to Promote Healthy Diet and Blood PressureCountries of recruitment: USAHealth conditions studied: high blood pressureInterventions:Active Comparator: Self-Guided ApproachIn 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 ApproachIn 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 CriteriaInclusion 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 periodExclusion 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 – 1/16/19Sample size – 200Recruitment status – recruitingPrimary outcome - Change in 24-hour Systolic Blood Pressure [Time Frame: Baseline to 12-week follow-up] Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak)Key secondary outcomesChange in 24-hour diastolic blood pressure [Time Frame: Baseline to 12-week follow-up] Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak)Change in Daytime Systolic Blood Pressure [Time Frame: Baseline to 12-week follow-up] Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak)Change in Nighttime Systolic Blood Pressure [Time Frame: Baseline to 12-week follow-up] Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak)Change in Daytime Diastolic Blood Pressure [Time Frame: Baseline to 12-week follow-up] Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak)Change in Nighttime Diastolic Blood Pressure [Time Frame: Baseline to 12-week follow-up] Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak)Change in Total Healthy Eating Index - 2015 score [Time Frame: Baseline to 12-week follow-up] Assessed by Viocare Food Frequency Questionnaire (score 0-100, 100=best possible score) Change in Weight [Time Frame: Baseline to 12-week follow-up] Weight measured at baseline and 12-week visits using a calibrated scale without shoesChange in Waist Circumference [Time Frame: Baseline to 12-week follow-up] Measured using Gulick II tape measureChange in Physical Activity (metabolic equivalent of task [MET]-minute per week[Time Frame: Baseline to 12-week follow-up] Measured by International Physical Activity Questionnaire (IPAQ) Short FormChange in Clinic systolic blood pressure (SBP) [Time Frame: Baseline to 12-week follow-up]Measured by average of 3 readings using Omron HEM 907XLChange in Clinic diastolic blood pressure (DBP) [Time Frame: Baseline to 12-week follow-up] Measured by average of 3 readings using Omron HEM 907XLEthics review – status approved, date of approval 10/2/2018Completion date – ongoingSummary results – N/AIPD sharing statement – Deidentified data may be shared upon reasonable request.Article summaryStrengths and limitations of this studyThis randomized controlled trial will compare the efficacy of a telehealth vs. self-directed lifestyle intervention in lowering blood pressure through lifestyle modification in patients with elevated blood pressure and overweight/obesityThe proposed interventions under investigation are low-cost and potentially scalablePrimary endpoint data will be collected using 24-hour ambulatory blood pressure monitoring at baseline and at 3 monthsAdditional secondary endpoint data will be collected including Healthy Eating Index-2015 score assessed by food frequency questionnaire, weight, waist circumference, and physical activity, assessed by questionnaireWhile participants and some of the study staff are unable to be blinded, researchers assessing study outcomes and conducting analyses will be blinded to the arms.