Comprehensive Approach to Lower Measured Blood Pressure (CALM-BP) - Results From a Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Assaf-Harofeh Medical Center
- Enrollment
- 113
- Locations
- 2
- Primary Endpoint
- Change in blood pressure
Study Overview
Brief Summary
Intervention description:
Complementary Approaches to Lower Mean arterial pressure (CALM) is a multi dispensary program aimed to reduce blood pressure in hypertensive patients. The program utilizes a naturopathic dietary approach, education on cooking and food consumption choices, walking physical exercise, Qi Gong - a form of Chinese slow movement exercise combined with relaxation breathing and imagery and group therapy coaching in stress management techniques and mind-body balancing techniques.
Trial Objectives:
To compare the effect of CALM in reducing blood pressure to the standard dietary DASH approach in hypertensive patients.
Methodology:
120 Participants will be randomly assigned in to two groups:
- CALM program for reducing blood pressure as the treatment group.
- Standard DASH diet and lifestyle modification counseling as the control group. Inclusion Criteria
- Adult men and women over 18 years.
- Patients using anti hypertensive medications with mean systolic blood pressure measurements of 120-180 mm Hg and/or mean diastolic measurements of 70-100 mm Hg as determined by a 24 hour Holter test.
- Patients not using anti hypertensive medications with mean systolic blood pressure measurements of 130-180 mm Hg and or mean diastolic measurements of 80-100 mmHg.
- Signed informed consent (appears in IRB forms)
Assessment of Efficacy Primary end point efficacy will be assessed by comparing the mean BP measurements in the CALM group to the mean BP measurements in the DASH control group. Blood pressure measurements will be performed by 24 hours Holter BP monitoring in the beginning and at the end of the trial.
Secondary end points efficacy will be assed by comparing CALM to DASH programs with respect to effects use of BP medications and weight loss. Lab test and pulse wave analysis will also be assessed at the beginning and at the end of the study.
Detailed Description
Intervention description Complementary Approaches to Lower Mean arterial pressure (CALM) utilizes a naturopathic dietary approach, education on cooking and food consumption choices, walking physical exercise, Qi Gong - a form of Chinese slow movement exercise combined with relaxation breathing and imagery and group therapy coaching in stress management techniques and mind-body balancing techniques.
Trial Objectives
Primary objective To compare the effect of CALM in reducing blood pressure to the standard dietary DASH approach in hypertensive patients.
Secondary objectives To provide information on the efficacy of CALM in reducing weight and improving quality of life. and to examine it's potential to indicate a dose reduction in hypertensive medications. To evaluate CALM effects on cardiovascular disease risk factors.
Trial Design
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult men and women over 18 years.
- •Patients using anti hypertensive medications with mean systolic blood pressure measurements of 120-180 mm Hg and/or mean diastolic measurements of 70-100 mm Hg as determined by a 24 hour Holter test.
- •Patients not using anti hypertensive medications with mean systolic blood pressure measurements of 130-180 mm Hg and or mean diastolic measurements of 80-100 mmHg.
- •Signed informed consent
Exclusion Criteria
- •Cardiovascular event within the past 6 months
- •Inability to walk independently for 15 or less minutes.
- •Poorly controlled insulin dependant diabetes mellitus with Hg A1c measurements over 7.
- •Inflammatory bowl disorders
- •Acute malignancy with life expectancy of less than 5 years.
- •Pregnancy or lactation
- •A body mass index of more than
- •More than 20 alcoholic beverages per weak.
- •Change in anti hypertensive medications within the last 3 months.
- •Planning to change smoking habits
Outcomes
Primary Outcomes
Change in blood pressure
Secondary Outcomes
No secondary outcomes reported