NCT01235702CompletedPhase 1
Multiple CVD Risk Reduction in Adult African-Americans: A Pilot Study
Morehouse School of Medicine1 site in 1 country210 target enrollmentStarted: September 1, 2002Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Morehouse School of Medicine
- Enrollment
- 210
- Locations
- 1
- Primary Endpoint
- blood pressure
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 21 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- body weight(10/2002 - 11/2003)
Investigators
Study Sites (1)
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