Remote Dietary Counseling to Promote Healthy Diet and Blood Pressure

Geisinger Health

Status: Completed

Conditions: High Blood Pressure; Overweight and Obesity; Dietary Modification; Blood Pressure

Treatments: Behavioral: Dietitian-led Approach; Behavioral: Self-Guided Approach

Study type: Interventional

Funder types: Other

Identifiers

NCT03700710

2018-0433

Details and patient eligibility

About

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.

Full 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.

Enrollment: 187 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

187 participants in 2 patient groups

Self-Guided Approach

Active Comparator group

Description:

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.

Treatment:

Behavioral: Self-Guided Approach

Dietitian-led Approach

Experimental group

Description:

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.

Treatment:

Behavioral: Dietitian-led Approach