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The Effect of a Complementary Multi Disciplinary Program on Blood Pressure in Hypertensive Patients

This study has been completed.
Sponsor:
Information provided by:
Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT00409149
First received: December 7, 2006
Last updated: January 16, 2011
Last verified: April 2007
History of Changes
  Purpose

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.


Condition Intervention Phase
Hypertension
 Behavioral: CALM Approache
Behavioral: DASH approach
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Comprehensive Approach to Lower Measured Blood Pressure (CALM-BP) - Results From a Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assaf-Harofeh Medical Center:

Primary Outcome Measures:
  • Change in blood pressure

Enrollment: 113
Study Start Date: December 2006
Study Completion Date: November 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CALM BP
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.
 Behavioral: CALM Approache
Active Comparator: DASH
standard dietary DASH approach in hypertensive patients
 Behavioral: DASH approach
standard dietary DASH approach in hypertensive patients

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 7.5.
  • Inflammatory bowl disorders
  • Acute malignancy with life expectancy of less than 5 years.
  • Pregnancy or lactation
  • A body mass index of more than 35.
  • More than 20 alcoholic beverages per weak.
  • Change in anti hypertensive medications within the last 3 months.
  • Planning to change smoking habits
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00409149

Locations
Israel
Research & Development Unit, Assaf-Harofeh Medical Center,
Zerifin, Israel, 70300
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Investigators
Principal Investigator: Shai Efrati, MD Assaf-Harofeh Medical Center
Study Chair: Amos Ziv, M.Sc. Assaf-Harofeh Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00409149     History of Changes
Other Study ID Numbers: 140/06
Study First Received: December 7, 2006
Last Updated: January 16, 2011
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Assaf-Harofeh Medical Center:
Hypertension
Diet
physical exercise
 naturopathic
group therapy
Qi Gong

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013