Remote Dietary Counseling to Promote Healthy Diet and Blood Pressure

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

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.

Study Overview

• Status: Completed
• Conditions: Blood Pressure; Overweight and Obesity; Dietary Modification; High Blood Pressure
• Intervention / Treatment: Behavioral: Self-Guided Approach; Behavioral: Dietitian-led Approach

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 Type: Interventional
• Enrollment (Actual): 187
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Medical Center
    • Wilkes-Barre, Pennsylvania, United States, 18711
      • Geisinger Wyoming Valley

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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.	Behavioral: Self-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.
EXPERIMENTAL: 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.	Behavioral: Dietitian-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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in individual components of Healthy Eating Index score	Each individual component of the Healthy Eating Index score will be examined	Baseline to 12-week follow-up
Satisfaction with the Healthy BP Research Study	5-point Likert score	12-week follow-up

Collaborators and Investigators

• Sponsor: Geisinger Clinic
• Investigators: Principal Investigator: Alexander Chang, MD, Geisinger Clinic

Publications and helpful links

General Publications

• Chang AR, Gummo L, Yule C, Bonaparte H, Collins C, Naylor A, Appel LJ, Juraschek SP, Bailey-Davis L. Effects of a Dietitian-Led, Telehealth Lifestyle Intervention on Blood Pressure: Results of a Randomized, Controlled Trial. J Am Heart Assoc. 2022 Oct 4;11(19):e027213. doi: 10.1161/JAHA.122.027213. Epub 2022 Sep 29.
• Taher M, Yule C, Bonaparte H, Kwiecien S, Collins C, Naylor A, Juraschek SP, Bailey-Davis L, Chang AR. Telehealth versus self-directed lifestyle intervention to promote healthy blood pressure: a protocol for a randomised controlled trial. BMJ Open. 2021 Mar 3;11(3):e044292. doi: 10.1136/bmjopen-2020-044292.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 16, 2019
• Primary Completion (ACTUAL): June 30, 2021
• Study Completion (ACTUAL): June 30, 2021

Study Registration Dates

• First Submitted: October 5, 2018
• First Submitted That Met QC Criteria: October 8, 2018
• First Posted (ACTUAL): October 9, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 28, 2021
• Last Update Submitted That Met QC Criteria: July 27, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: exercise; weight loss; lifestyle modification; DASH diet
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Body Weight; Hypertension; Overweight
• Other Study ID Numbers: 2018-0433

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The study protocol, statistical analysis plan, informed consent form, analytic code, and clinical study report will be shared at the time of publication of the main trial results; these data will be deidentified. These data will be publicly available indefinitely.
• IPD Sharing Time Frame: Data will become available at the time of publication of the main trial results and will be publicly available indefinitely.
• IPD Sharing Access Criteria: The deidentified IPD will be publicly available without restrictions.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No