An interventional study of Self-Guided Approach and Dietitian-led Approach in Blood Pressure, High Blood Pressure and Dietary Modification, sponsored by Geisinger Clinic. Completed at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-28.
Sponsored by Geisinger Clinic · Not applicable, Interventional, and Treatment
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.
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.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's enrollment of 187 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.
Browse Hypertension studies →Geisinger Clinic is the lead sponsor of 125 studies on the registry; 21 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 7 (78%) have results posted.
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Exclusion Criteria:
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
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.
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.
Change in 24-hour Systolic Blood Pressure
Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak)
Time frame: Baseline to 12-week follow-up
Change in 24-hour diastolic blood pressure
Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak)
Time frame: Baseline to 12-week follow-up
Change in Daytime Systolic Blood Pressure
Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak)
Time frame: Baseline to 12-week follow-up
Change in Nighttime Systolic Blood Pressure
Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak)
Time frame: Baseline to 12-week follow-up
Change in Daytime Diastolic Blood Pressure
Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak)
Time frame: Baseline to 12-week follow-up
Change in Nighttime Diastolic Blood Pressure
Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak)
Time frame: Baseline to 12-week follow-up
Change in Total Healthy Eating Index - 2015 score
Assessed by Viocare Food Frequency Questionnaire (score 0-100, 100=best possible score)
Time frame: Baseline to 12-week follow-up
Change in Weight
Weight measured at baseline and 12-week visits without shoes
Time frame: Baseline to 12-week follow-up
Change in Waist Circumference
Measured using a tape measure
Time frame: Baseline to 12-week follow-up
Change in Physical Activity (metabolic equivalent of task [MET]-minute per week
Measured by International Physical Activity Questionnaire (IPAQ) Short Form
Time frame: Baseline to 12-week follow-up
Change in individual components of Healthy Eating Index score
Each individual component of the Healthy Eating Index score will be examined
Time frame: Baseline to 12-week follow-up
Satisfaction with the Healthy BP Research Study
5-point Likert score
Time frame: 12-week follow-up
Plan to share: Yes — 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 information: Study protocol, Sap, Icf, Csr, Analytic code
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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