Back to resultsRemote Dietary Counseling to Promote Healthy Diet and Blood Pressure
Primary Purpose
Blood Pressure, High Blood Pressure, Dietary Modification
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Self-Guided Approach
Dietitian-led Approach
Sponsored by
About this trial
This is an interventional treatment trial for Blood Pressure focused on measuring lifestyle modification, DASH diet, weight loss, exercise
Eligibility Criteria
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)
Sites / Locations
- Geisinger Medical Center
- Geisinger Wyoming Valley
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Self-Guided Approach
Dietitian-led Approach
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change in 24-hour Systolic Blood Pressure
Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak)
Secondary Outcome Measures
Change in 24-hour diastolic blood pressure
Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak)
Change in Daytime Systolic Blood Pressure
Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak)
Change in Nighttime Systolic Blood Pressure
Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak)
Change in Daytime Diastolic Blood Pressure
Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak)
Change in Nighttime Diastolic Blood Pressure
Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak)
Change in Total Healthy Eating Index - 2015 score
Assessed by Viocare Food Frequency Questionnaire (score 0-100, 100=best possible score)
Change in Weight
Weight measured at baseline and 12-week visits without shoes
Change in Waist Circumference
Measured using a tape measure
Change in Physical Activity (metabolic equivalent of task [MET]-minute per week
Measured by International Physical Activity Questionnaire (IPAQ) Short Form
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03700710
Brief Title
Remote Dietary Counseling to Promote Healthy Diet and Blood Pressure
Official Title
Remote Dietary Counseling Using Web-based Tools to Promote Healthy Diet and Blood Pressure (Healthy BP)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
January 16, 2019 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Geisinger Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Pressure, High Blood Pressure, Dietary Modification, Overweight and Obesity
Keywords
lifestyle modification, DASH diet, weight loss, exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
187 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Self-Guided Approach
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Dietitian-led Approach
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Self-Guided Approach
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Dietitian-led Approach
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in 24-hour Systolic Blood Pressure
Description
Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak)
Time Frame
Baseline to 12-week follow-up
Secondary Outcome Measure Information:
Title
Change in 24-hour diastolic blood pressure
Description
Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak)
Time Frame
Baseline to 12-week follow-up
Title
Change in Daytime Systolic Blood Pressure
Description
Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak)
Time Frame
Baseline to 12-week follow-up
Title
Change in Nighttime Systolic Blood Pressure
Description
Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak)
Time Frame
Baseline to 12-week follow-up
Title
Change in Daytime Diastolic Blood Pressure
Description
Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak)
Time Frame
Baseline to 12-week follow-up
Title
Change in Nighttime Diastolic Blood Pressure
Description
Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak)
Time Frame
Baseline to 12-week follow-up
Title
Change in Total Healthy Eating Index - 2015 score
Description
Assessed by Viocare Food Frequency Questionnaire (score 0-100, 100=best possible score)
Time Frame
Baseline to 12-week follow-up
Title
Change in Weight
Description
Weight measured at baseline and 12-week visits without shoes
Time Frame
Baseline to 12-week follow-up
Title
Change in Waist Circumference
Description
Measured using a tape measure
Time Frame
Baseline to 12-week follow-up
Title
Change in Physical Activity (metabolic equivalent of task [MET]-minute per week
Description
Measured by International Physical Activity Questionnaire (IPAQ) Short Form
Time Frame
Baseline to 12-week follow-up
Other Pre-specified Outcome Measures:
Title
Change in individual components of Healthy Eating Index score
Description
Each individual component of the Healthy Eating Index score will be examined
Time Frame
Baseline to 12-week follow-up
Title
Satisfaction with the Healthy BP Research Study
Description
5-point Likert score
Time Frame
12-week follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Chang, MD
Organizational Affiliation
Geisinger Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Facility Name
Geisinger Wyoming Valley
City
Wilkes-Barre
State/Province
Pennsylvania
ZIP/Postal Code
18711
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
36172955
Citation
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.
Results Reference
derived
PubMed Identifier
33658261
Citation
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.
Results Reference
derived
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Remote Dietary Counseling to Promote Healthy Diet and Blood Pressure
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