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

NCT00409149 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 113

Last updated 2011-01-19

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

CALM Approache

BEHAVIORAL

DASH approach

standard dietary DASH approach in hypertensive patients

Sponsors & Collaborators

  • Assaf-Harofeh Medical Center

    lead OTHER_GOV

Principal Investigators

  • Shai Efrati, MD · Assaf-Harofeh Medical Center

  • Amos Ziv, M.Sc. · Assaf-Harofeh Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2008-10-31
Completion
2009-11-30

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00409149 on ClinicalTrials.gov