Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self-Guided Approach | Active Comparator | 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. |
|
| Dietitian-led Approach | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 24-hour Systolic Blood Pressure | Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak) | Baseline to 12-week follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 24-hour diastolic blood pressure | Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak) | Baseline to 12-week follow-up |
| Change in Daytime Systolic Blood Pressure |
| Measure | Description | Time Frame |
|---|---|---|
| Change in individual components of Healthy Eating Index score | Each individual component of the Healthy Eating Index score will be examined | Baseline to 12-week follow-up |
| Satisfaction with the Healthy BP Research Study |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alexander Chang, MD | Geisinger Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | United States | ||
| Geisinger Wyoming Valley |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36172955 | Derived | 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. | |
| 33658261 | Derived |
Not provided
Not provided
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.
Data will become available at the time of publication of the main trial results and will be publicly available indefinitely.
The deidentified IPD will be publicly available without restrictions.
Not provided
Not provided
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D050177 | Overweight |
| D009765 | Obesity |
| D015431 | Weight Loss |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak)
| Baseline to 12-week follow-up |
| Change in Nighttime Systolic Blood Pressure | Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak) | Baseline to 12-week follow-up |
| Change in Daytime Diastolic Blood Pressure | Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak) | Baseline to 12-week follow-up |
| Change in Nighttime Diastolic Blood Pressure | Measured by 24-hour ambulatory blood pressure monitoring (SpaceLabs Ontrak) | 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) | Baseline to 12-week follow-up |
| Change in Weight | Weight measured at baseline and 12-week visits without shoes | Baseline to 12-week follow-up |
| Change in Waist Circumference | Measured using a tape measure | 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 | Baseline to 12-week follow-up |
5-point Likert score
| 12-week follow-up |
| Wilkes-Barre |
| Pennsylvania |
| 18711 |
| United States |
| 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. |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D001519 | Behavior |