Remote Dietary Counseling to Promote Healthy Diet and Blood Pressure

Study Overview
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Brief Summary
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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
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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.

Official Title
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Remote Dietary Counseling Using Web-based Tools to Promote Healthy Diet and Blood Pressure (Healthy BP)

Conditions
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Blood Pressure, High Blood Pressure, Dietary Modification, Overweight and Obesity

Intervention / Treatment
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* Behavioral: Self-Guided Approach
* Behavioral: Dietitian-led Approach


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Self-Guided Approach<br>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 an evidence-based program (Evolve, formerly BMIQ), which includes program materials for weight loss and leading a healthy lifestyle as well as the ability for capturing dietary data entry. | Behavioral: Self-Guided Approach<br>* 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.<br>|
| Experimental: Dietitian-led Approach<br>In the dietitian-led arm, dietitian will use motivational interviewing in 15-30 minute telephone calls with participants. 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 an evidence-based program (Evolve, formerly BMIQ), which includes program materials for weight loss and leading a healthy lifestyle as well as the ability for capturing dietary data entry. The web platform will be used to share participant dietary and weight data with dietitians. | Behavioral: Dietitian-led Approach<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 24-hour Systolic Blood Pressure | Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak) | Baseline to 12-week follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 24-hour diastolic blood pressure | Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak) | Baseline to 12-week follow-up | 
| Change in Daytime Systolic Blood Pressure | Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak) | Baseline to 12-week follow-up | 
| Change in Nighttime Systolic Blood Pressure | Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak) | Baseline to 12-week follow-up | 
| Change in Daytime Diastolic Blood Pressure | Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak) | Baseline to 12-week follow-up | 
| Change in Nighttime Diastolic Blood Pressure | Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak) | Baseline to 12-week follow-up | 
| Change in Total Healthy Eating Index - 2015 score | Assessed by Viocare Food Frequency Questionnaire (score 0-100, 100=best possible score) | Baseline to 12-week follow-up | 
| Change in Weight | Weight measured at baseline and 12-week visits without shoes | Baseline to 12-week follow-up | 
| Change in Waist Circumference | Measured using a tape measure | Baseline to 12-week follow-up | 
| Change in Physical Activity (metabolic equivalent of task [MET]-minute per week | Measured by International Physical Activity Questionnaire (IPAQ) Short Form | Baseline to 12-week follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lifestyle modification, DASH diet, weight loss, exercise