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Completed

NCT Number: NCT03700710

Remote Dietary Counseling to Promote Healthy Diet and Blood Pressure

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.

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Key information

Conditions

Blood Pressure Behavior Body Weight Body Weight Changes Cardiovascular Diseases Dietary Modification High Blood Pressure Hypertension Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Overweight and Obesity Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases Weight Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Geisinger Medical Center, Danville, Pennsylvania, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Self-Guided Approach

Behavioral

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

Behavioral

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 outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Geisinger Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 9, 2018
Registry last updated
Jul 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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