Remote Dietary Counseling Using Web-based Tools to Promote Healthy Diet and Blood Pressure (Healthy BP)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Geisinger Clinic
- Enrollment
- 187
- Locations
- 4
- Primary Endpoint
- Change in 24-hour Systolic Blood Pressure
Study Overview
Brief Summary
American College of Cardiology/American Heart Association (ACC/AHA) hypertension guidelines recommend lifestyle modification for patients with elevated blood pressure. While eating a Dietary Approaches to Stop Hypertension (DASH)-type diet, increasing physical activity, and weight loss have been shown to reduce blood pressure, limited resources are available in the primary care setting to help patients make these changes.
In this study, the investigators will compare the efficacy of a self-guided vs. dietitian-led approach using web-based lifestyle modification tools to reduce weight, improve dietary quality, and lower blood pressure in overweight/obese adults with elevated blood pressure.
Detailed Description
Goals that all participants will be instructed to target include: 1) weight loss >=3% at 3 months; 2) consume a healthier dietary pattern (high in fruits, vegetables, whole grains, low-fat dairy, vegetable/fish/poultry sources of protein, healthier sources of fat, and avoid sugar and salt); 3) reduce sodium intake to <2300 mg/d; 4) at least 180 min/wk of moderate-intensity physical activity.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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 for at least 5 out of 7 days during run-in period
- •Enter weight into the platform 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)
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- Change in Nighttime Diastolic Blood Pressure(Baseline to 12-week follow-up)
- Change in Total Healthy Eating Index - 2015 score(Baseline to 12-week follow-up)
- Change in Waist Circumference(Baseline to 12-week follow-up)
- Change in Physical Activity (metabolic equivalent of task [MET]-minute per week(Baseline to 12-week follow-up)
- Change in Daytime Systolic Blood Pressure(Baseline to 12-week follow-up)
- Change in 24-hour diastolic blood pressure(Baseline to 12-week follow-up)
- Change in Nighttime Systolic Blood Pressure(Baseline to 12-week follow-up)
- Change in Daytime Diastolic Blood Pressure(Baseline to 12-week follow-up)
- Change in Weight(Baseline to 12-week follow-up)