NCT00409149

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
113

participants targeted

Target at below P25 for phase_3 hypertension

Timeline
Completed

Started Dec 2006

Longer than P75 for phase_3 hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

December 7, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 8, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

January 19, 2011

Status Verified

April 1, 2007

Enrollment Period

1.8 years

First QC Date

December 7, 2006

Last Update Submit

January 16, 2011

Conditions

Hypertension

Keywords

HypertensionDietphysical exercisenaturopathicgroup therapyQi Gong

Outcome Measures

Primary Outcomes (1)

  • Change in blood pressure

Study Arms (2)

CALM BP

EXPERIMENTAL

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

DASH

ACTIVE COMPARATOR

standard dietary DASH approach in hypertensive patients

Behavioral: DASH approach

Interventions

CALM ApproacheBEHAVIORAL
CALM BP
DASH approachBEHAVIORAL

standard dietary DASH approach in hypertensive patients

DASH

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research & Development Unit, Assaf-Harofeh Medical Center,

Ẕerifin, 70300, Israel

Location

MeSH Terms

Conditions

HypertensionMotor Activity

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesBehavior

Study Officials

  • Shai Efrati, MD

    Assaf-Harofeh Medical Center

    PRINCIPAL INVESTIGATOR

  • Amos Ziv, M.Sc.

    Assaf-Harofeh Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

December 7, 2006

First Posted

December 8, 2006

Study Start

December 1, 2006

Primary Completion

October 1, 2008

Study Completion

November 1, 2009

Last Updated

January 19, 2011

Record last verified: 2007-04

Locations

IL(1)