Blood Pressure, Dietary Modification, High Blood Pressure, Overweight and Obesity
Conditions
Keywords
lifestyle modification, DASH diet, weight loss, exercise
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.
Interventions
BEHAVIORALSelf-Guided Approach
For a 12-week period, patients will be asked to access the web platform (Evolve, formerly BMIQ), review educational materials, and enter dietary information. From January 2019 to February 2021, participants used an earlier version of the platform, which was used in tandem with LoseIt (www.loseit.com), a meal-logging app that integrated with the platform. In February 2021, a platform update occurred (Evolve) where the core tenets of the program remained the same and included the dietary data entry directly on the platform.
BEHAVIORALDietitian-led Approach
For a 12-week period, patients will be asked to access the web platform (Evolve, formerly BMIQ), review educational materials, and enter dietary information. From January 2019 to February 2021, participants used an earlier version of the platform, which was used in tandem with LoseIt (www.loseit.com), a meal-logging app that integrated with the platform. In February 2021, a platform update occurred (Evolve) where the core tenets of the program remained the same and included the dietary data entry directly on the platform. Dietitians will access the web platform and provided personalized motivational interview phone calls on a weekly basis.
Sponsors
Geisinger Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in 24-hour Systolic Blood Pressure | Baseline to 12-week follow-up | Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in 24-hour diastolic blood pressure | Baseline to 12-week follow-up | Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak) |
| Change in Daytime Systolic Blood Pressure | Baseline to 12-week follow-up | Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak) |
| Change in Nighttime Systolic Blood Pressure | Baseline to 12-week follow-up | Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak) |
| Change in Daytime Diastolic Blood Pressure | Baseline to 12-week follow-up | Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak) |
| Change in Nighttime Diastolic Blood Pressure | Baseline to 12-week follow-up | Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak) |
| Change in Waist Circumference | Baseline to 12-week follow-up | Measured using a tape measure |
| Change in Physical Activity (metabolic equivalent of task [MET]-minute per week | Baseline to 12-week follow-up | Measured by International Physical Activity Questionnaire (IPAQ) Short Form |
| Change in Total Healthy Eating Index - 2015 score | Baseline to 12-week follow-up | Assessed by Viocare Food Frequency Questionnaire (score 0-100, 100=best possible score) |
| Change in Weight | Baseline to 12-week follow-up | Weight measured at baseline and 12-week visits without shoes |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in individual components of Healthy Eating Index score | Baseline to 12-week follow-up | Each individual component of the Healthy Eating Index score will be examined |
| Satisfaction with the Healthy BP Research Study | 12-week follow-up | 5-point Likert score |
Countries
United States
Outcome results
None listed