Remote Dietary Counseling to Promote Healthy Diet and Blood Pressure

Not Applicable

Completed

• Conditions: Overweight and Obesity; Blood Pressure; High Blood Pressure; Dietary Modification
• Interventions: Behavioral: Self-Guided Approach; Behavioral: Dietitian-led Approach

• Registration Number: NCT03700710
• Lead Sponsor: Geisinger Clinic

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 Timeline

• Study First Submitted: 2018-10-05
• Study First Submitted QC: 2018-10-08
• Study First Posted: 2018-10-09
• Study Start: 2019-01-16
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-27
• Last Update Posted: 2021-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 187

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self-Guided Approach	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 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.
Dietitian-led Approach	Dietitian-led Approach	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.

Primary Outcome Measures

Name	Time	Method
Change in 24-hour Systolic Blood Pressure	Baseline to 12-week follow-up	Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak)

Secondary Outcome Measures

Name	Time	Method
Change in Nighttime Diastolic Blood Pressure	Baseline to 12-week follow-up	Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak)
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 Waist Circumference	Baseline to 12-week follow-up	Measured using a tape measure
Change in Daytime Systolic Blood Pressure	Baseline to 12-week follow-up	Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak)
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 24-hour diastolic 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 Weight	Baseline to 12-week follow-up	Weight measured at baseline and 12-week visits without shoes

Trial Locations

Locations (2)

Geisinger Wyoming Valley; 🇺🇸 Wilkes-Barre, Pennsylvania, United States

Geisinger Medical Center; 🇺🇸 Danville, Pennsylvania, United States