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Remote Dietary Counseling to Promote Healthy Diet and Blood Pressure

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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

Tracking Information
First Submitted Date  ICMJE October 5, 2018
First Posted Date  ICMJE October 9, 2018
Last Update Posted Date July 28, 2021
Actual Study Start Date  ICMJE January 16, 2019
Actual Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2018)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: October 8, 2018)
  • 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)
  • Change in Weight [ Time Frame: Baseline to 12-week follow-up ]
    Change in Weight
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2021)
  • 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)
  • Change in Daytime Systolic Blood Pressure [ Time Frame: Baseline to 12-week follow-up ]
    Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak)
  • Change in Nighttime Systolic Blood Pressure [ Time Frame: Baseline to 12-week follow-up ]
    Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak)
  • Change in Daytime Diastolic Blood Pressure [ Time Frame: Baseline to 12-week follow-up ]
    Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak)
  • Change in Nighttime Diastolic Blood Pressure [ Time Frame: Baseline to 12-week follow-up ]
    Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak)
  • 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)
  • Change in Weight [ Time Frame: Baseline to 12-week follow-up ]
    Weight measured at baseline and 12-week visits without shoes
  • Change in Waist Circumference [ Time Frame: Baseline to 12-week follow-up ]
    Measured using a tape measure
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: October 8, 2018)
  • Change in Healthy Eating Index [ Time Frame: Baseline to 12-week follow-up ]
    Assessed by Viocare Food Frequency Questionnaire
  • Change in Waist Circumference [ Time Frame: Baseline to 12-week follow-up ]
    Measured using Gulick II tape measure
  • 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)
  • Change in Clinic SBP [ Time Frame: Baseline to 12-week follow-up ]
    Measured by average of 3 readings using Omron HEM 907XL
  • Change in Clinic DBP [ Time Frame: Baseline to 12-week follow-up ]
    Measured by average of 3 readings using Omron HEM 907XL
  • Change in Physical Activity [ Time Frame: Baseline to 12-week follow-up ]
    Measured by International Physical Activity Questionnaire (IPAQ) Short Form
  • Patient Satisfaction: Questionnaire [ Time Frame: 12-week follow-up ]
    Questionnaire
Current Other Pre-specified Outcome Measures
 (submitted: October 4, 2019)
  • 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
  • Satisfaction with the Healthy BP Research Study [ Time Frame: 12-week follow-up ]
    5-point Likert score
Original Other Pre-specified Outcome Measures
 (submitted: October 8, 2018)
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
 
Descriptive Information
Brief Title  ICMJE Remote Dietary Counseling to Promote Healthy Diet and Blood Pressure
Official Title  ICMJE Remote Dietary Counseling Using Web-based Tools to Promote Healthy Diet and Blood Pressure (Healthy BP)
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Blood Pressure
  • High Blood Pressure
  • Dietary Modification
  • Overweight and Obesity
Intervention  ICMJE
  • 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.

  • 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.

Study Arms  ICMJE
  • 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.

    Intervention: Behavioral: Self-Guided Approach
  • 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.

    Intervention: Behavioral: Dietitian-led Approach
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 2, 2021)
187
Original Estimated Enrollment  ICMJE
 (submitted: October 8, 2018)
160
Actual Study Completion Date  ICMJE June 30, 2021
Actual Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03700710
Other Study ID Numbers  ICMJE 2018-0433
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: 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.
Current Responsible Party Geisinger Clinic
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Geisinger Clinic
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alexander Chang, MD Geisinger Clinic
PRS Account Geisinger Clinic
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP