Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Remote Dietary Counseling to Promote Healthy Diet and Blood Pressure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03700710
Recruitment Status : Completed
First Posted : October 9, 2018
Last Update Posted : July 28, 2021
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Blood Pressure High Blood Pressure Dietary Modification Overweight and Obesity Behavioral: Self-Guided Approach Behavioral: Dietitian-led Approach Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 187 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Remote Dietary Counseling Using Web-based Tools to Promote Healthy Diet and Blood Pressure (Healthy BP)
Actual Study Start Date : January 16, 2019
Actual Primary Completion Date : June 30, 2021
Actual Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


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.





Primary Outcome Measures :
  1. Change in 24-hour Systolic Blood Pressure [ Time Frame: Baseline to 12-week follow-up ]
    Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak)


Secondary Outcome Measures :
  1. Change in 24-hour diastolic blood pressure [ Time Frame: Baseline to 12-week follow-up ]
    Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak)

  2. Change in Daytime Systolic Blood Pressure [ Time Frame: Baseline to 12-week follow-up ]
    Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak)

  3. Change in Nighttime Systolic Blood Pressure [ Time Frame: Baseline to 12-week follow-up ]
    Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak)

  4. Change in Daytime Diastolic Blood Pressure [ Time Frame: Baseline to 12-week follow-up ]
    Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak)

  5. Change in Nighttime Diastolic Blood Pressure [ Time Frame: Baseline to 12-week follow-up ]
    Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak)

  6. Change in Total Healthy Eating Index - 2015 score [ Time Frame: Baseline to 12-week follow-up ]
    Assessed by Viocare Food Frequency Questionnaire (score 0-100, 100=best possible score)

  7. Change in Weight [ Time Frame: Baseline to 12-week follow-up ]
    Weight measured at baseline and 12-week visits without shoes

  8. Change in Waist Circumference [ Time Frame: Baseline to 12-week follow-up ]
    Measured using a tape measure

  9. Change in Physical Activity (metabolic equivalent of task [MET]-minute per week [ Time Frame: Baseline to 12-week follow-up ]
    Measured by International Physical Activity Questionnaire (IPAQ) Short Form


Other Outcome Measures:
  1. Change in individual components of Healthy Eating Index score [ Time Frame: Baseline to 12-week follow-up ]
    Each individual component of the Healthy Eating Index score will be examined

  2. Satisfaction with the Healthy BP Research Study [ Time Frame: 12-week follow-up ]
    5-point Likert score



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03700710


Locations
Layout table for location information
United States, Pennsylvania
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Geisinger Wyoming Valley
Wilkes-Barre, Pennsylvania, United States, 18711
Sponsors and Collaborators
Geisinger Clinic
Investigators
Layout table for investigator information
Principal Investigator: Alexander Chang, MD Geisinger Clinic
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Geisinger Clinic
ClinicalTrials.gov Identifier: NCT03700710    
Other Study ID Numbers: 2018-0433
First Posted: October 9, 2018    Key Record Dates
Last Update Posted: July 28, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data will become available at the time of publication of the main trial results and will be publicly available indefinitely.
Access Criteria: The deidentified IPD will be publicly available without restrictions.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Geisinger Clinic:
lifestyle modification
DASH diet
weight loss
exercise
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension
Overweight
Body Weight
Vascular Diseases
Cardiovascular Diseases