Metro Atlanta Heart Disease Study - II (MAHDS II)

November 4, 2010 updated by: Morehouse School of Medicine

Multiple CVD Risk Reduction in Adult African-Americans: A Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

210

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30310
        • Morehouse School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

-

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.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood pressure
Time Frame: 10/2002 - 11/2003
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.
10/2002 - 11/2003

Secondary Outcome Measures

Outcome Measure
Time Frame
body weight
Time Frame: 10/2002 - 11/2003
10/2002 - 11/2003

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Morehouse School of Medicine

Investigators

  • Principal Investigator: Sharon K Davis, PhD, Morehouse School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Primary Completion (Actual)

October 1, 2003

Study Completion (Actual)

October 1, 2003

Study Registration Dates

First Submitted

November 4, 2010

First Submitted That Met QC Criteria

November 4, 2010

First Posted (Estimate)

November 5, 2010

Study Record Updates

Last Update Posted (Estimate)

November 5, 2010

Last Update Submitted That Met QC Criteria

November 4, 2010

Last Verified

March 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TS-0724

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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