Remote Dietary Counseling to Promote Healthy Diet and Blood Pressure

Overweight and Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03700710
• Other study ID #: 2018-0433
• Status: Completed
• Phase: N/A
• Start date: January 16, 2019
• Est. completion date: June 30, 2021

Study information

• Verified date: July 2021
• Source: Geisinger Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 187
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Blood Pressure
• Dietary Modification
• High Blood Pressure
• Hypertension
• Overweight
• Overweight and Obesity

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Geisinger Wyoming Valley	Wilkes-Barre	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Geisinger Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Satisfaction with the Healthy BP Research Study	5-point Likert score	12-week follow-up
Primary	Change in 24-hour Systolic Blood Pressure	Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak)	Baseline to 12-week follow-up
Secondary	Change in 24-hour diastolic blood pressure	Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak)	Baseline to 12-week follow-up
Secondary	Change in Daytime Systolic Blood Pressure	Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak)	Baseline to 12-week follow-up
Secondary	Change in Nighttime Systolic Blood Pressure	Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak)	Baseline to 12-week follow-up
Secondary	Change in Daytime Diastolic Blood Pressure	Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak)	Baseline to 12-week follow-up
Secondary	Change in Nighttime Diastolic Blood Pressure	Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak)	Baseline to 12-week follow-up
Secondary	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
Secondary	Change in Weight	Weight measured at baseline and 12-week visits without shoes	Baseline to 12-week follow-up
Secondary	Change in Waist Circumference	Measured using a tape measure	Baseline to 12-week follow-up
Secondary	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