NCT00860444

Brief Summary

Cardiovascular disease (CVD) is a serious health problem among African American women. This study will evaluate a health care center-based program that aims to encourage African American women to eat a low fat diet and increase their physical activity levels to reduce the risk of developing CVD.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
266

participants targeted

Target at P25-P50 for phase_3 cardiovascular-diseases

Timeline
Completed

Started May 2005

Shorter than P25 for phase_3 cardiovascular-diseases

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 12, 2009

Completed
Last Updated

January 7, 2014

Status Verified

January 1, 2014

Enrollment Period

2.9 years

First QC Date

March 10, 2009

Last Update Submit

January 6, 2014

Conditions

Cardiovascular Diseases

Keywords

Primary CareDietPhysical Activity

Outcome Measures

Primary Outcomes (2)

  • Hours per week in moderate and vigorous intensity physical activities (MVPA), as measured by the Community Healthy Activities Model Program for Seniors (CHAMPS) Physical Activity Questionnaire

    Measured at baseline and Months 6 and 12

  • Weekly consumption frequency of dietary fat and cholesterol, as measured by the New Leaf Dietary Risk Assessment (DRA)

    Measured at baseline and Months 6 and 12

Secondary Outcomes (3)

  • Body mass index (weight [kg]/height [m2])

    Measured at baseline and Months 6 and 12

  • Central adiposity (i.e., waist circumference in inches)

    Measured at baseline and Months 6 and 12

  • Total cholesterol (mg/dL)

    Measured at baseline and Months 6 and 12

Study Arms (2)

1

ACTIVE COMPARATOR

Participants will take part in the basic educational and counseling program through their community health care center.

Behavioral: Basic Educational and Counseling Program

2

EXPERIMENTAL

Participants will take part in the comprehensive educational and counseling program through their community health care center.

Behavioral: Comprehensive Educational and Counseling Program

Interventions

Basic Educational and Counseling ProgramBEHAVIORAL

Participants will receive one session of brief patient-centered physician counseling, along with educational handouts and nurse-assisted guidance with goal-setting.

1
Comprehensive Educational and Counseling ProgramBEHAVIORAL

Participants will receive one session of brief patient-centered physician counseling, along with educational handouts and nurse-assisted guidance with goal-setting. They will also receive 12 months of telephone counseling and a monthly newsletter.

2

Eligibility Criteria

Age35 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • African American women
  • Able and willing to complete survey instruments and assessment procedures

You may not qualify if:

  • Physical disability or orthopedic problem that limits physical activity
  • Elevated blood pressure (i.e., greater than 160/95 mm Hg)
  • Insulin-dependent diabetes
  • Pregnant or planning to become pregnant during the study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Parra-Medina D, Wilcox S, Wilson DK, Addy CL, Felton G, Poston MB. Heart Healthy and Ethnically Relevant (HHER) Lifestyle trial for improving diet and physical activity in underserved African American women. Contemp Clin Trials. 2010 Jan;31(1):92-104. doi: 10.1016/j.cct.2009.09.006. Epub 2009 Sep 22.

    PMID: 19781665BACKGROUND

  • Parra-Medina D, Wilcox S, Salinas J, Addy C, Fore E, Poston M, Wilson DK. Results of the Heart Healthy and Ethnically Relevant Lifestyle trial: a cardiovascular risk reduction intervention for African American women attending community health centers. Am J Public Health. 2011 Oct;101(10):1914-21. doi: 10.2105/AJPH.2011.300151. Epub 2011 Aug 18.

    PMID: 21852629RESULT

  • Wilcox S, Parra-Medina D, Felton GM, Poston MB, McClain A. Adoption and implementation of physical activity and dietary counseling by community health center providers and nurses. J Phys Act Health. 2010 Sep;7(5):602-12. doi: 10.1123/jpah.7.5.602.

    PMID: 20864755RESULT

MeSH Terms

Conditions

Cardiovascular DiseasesMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Deborah Parra-Medina, PhD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Epidemiology and Biostatistics

Study Record Dates

First Submitted

March 10, 2009

First Posted

March 12, 2009

Study Start

May 1, 2005

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

January 7, 2014

Record last verified: 2014-01