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Metro Atlanta Heart Disease Study - II (MAHDS II)

This study has been completed.
Sponsor:
Information provided by:
Morehouse School of Medicine
ClinicalTrials.gov Identifier:
NCT01235702
First received: November 4, 2010
Last updated: NA
Last verified: March 2003
History: No changes posted
  Purpose

A 12-week treatment/control trial was implemented to assess the effects of a multi component lifestyle program on improvements in body mass index, weight, perceived stress and blood pressure in African American men and women who were at increased risk for cardiovascular disease. It was hypothesized that treatment group would experience significant improvements when compared to the control group.


Condition Intervention Phase
African Americans With Hypertension.
 Behavioral: 12-week lifestyle modification
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Multiple CVD Risk Reduction in Adult African-Americans: A Pilot Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Morehouse School of Medicine:

Primary Outcome Measures:
  • blood pressure [ Time Frame: 10/2002 - 11/2003 ] [ Designated as safety issue: No ]
    a 12-week behavior modification program was implemented to assess the effects of nutrition counseling, stress reduction education, and directed physical activity on African Americans at increased risk for cardiovascular disease.


Secondary Outcome Measures:
  • body weight [ Time Frame: 10/2002 - 11/2003 ] [ Designated as safety issue: No ]

Enrollment: 210
Study Start Date: September 2002
Study Completion Date: October 2003
Primary Completion Date: October 2003 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: African American men and women aged >21 with elevated blood pressure and excess body weight who resided in metro Atlanta, GA.

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Exclusion Criteria: Individuals with normal blood pressure and body weight, as well as those residing outside of metro Atlanta, GA. Individuals with psychological conditions were also excluded.

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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01235702

Locations
United States, Georgia
Morehouse School of Medicine
Atlanta, Georgia, United States, 30310
Sponsors and Collaborators
Morehouse School of Medicine
Investigators
Principal Investigator: Sharon K Davis, PhD Morehouse School of Medicine
  More Information

No publications provided

Responsible Party: Sharon K Davis, PhD Director- Social Epidemiology Research Center, Morehouse School of Medicine
ClinicalTrials.gov Identifier: NCT01235702     History of Changes
Other Study ID Numbers: TS-0724
Study First Received: November 4, 2010
Last Updated: November 4, 2010
Health Authority: United States: Federal Government

Keywords provided by Morehouse School of Medicine:
high blood pressure, hypertension, African Americans, perceived stress

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013