Clinical trial NCT03700710: Remote Dietary Counseling to Promote Healthy Diet and Blood Pressure
Official title: Remote Dietary Counseling Using Web-based Tools to Promote Healthy Diet and Blood Pressure (Healthy BP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
High Blood Pressure
Dietary Modification
Overweight and Obesity
Keywords: lifestyle modification
DASH diet
weight loss
exercise
Lead sponsor: Geisinger Clinic
Sponsor class: OTHER
First posted: 2018-10-09
Enrollment: 187
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: Change in 24-hour Systolic Blood Pressure
timeFrame: Baseline to 12-week follow-up
Secondary outcomes:
measure: Change in 24-hour diastolic blood pressure
timeFrame: Baseline to 12-week follow-up
measure: Change in Daytime Systolic Blood Pressure
timeFrame: Baseline to 12-week follow-up
measure: Change in Nighttime Systolic Blood Pressure
timeFrame: Baseline to 12-week follow-up
measure: Change in Daytime Diastolic Blood Pressure
timeFrame: Baseline to 12-week follow-up
measure: Change in Nighttime Diastolic Blood Pressure
timeFrame: Baseline to 12-week follow-up
measure: Change in Total Healthy Eating Index - 2015 score
timeFrame: Baseline to 12-week follow-up
measure: Change in Weight
timeFrame: Baseline to 12-week follow-up
measure: Change in Waist Circumference
timeFrame: Baseline to 12-week follow-up
measure: Change in Physical Activity (metabolic equivalent of task [MET]-minute per week
timeFrame: Baseline to 12-week follow-up
Other outcomes:
measure: Change in individual components of Healthy Eating Index score
timeFrame: Baseline to 12-week follow-up
measure: Satisfaction with the Healthy BP Research Study
timeFrame: 12-week follow-up
Locations:
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Wilkes-Barre
country: United States
facility: Geisinger Wyoming Valley
state: Pennsylvania
Study officials:
affiliation: Geisinger Clinic
name: Alexander Chang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.