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West Philadelphia Consortium Randomized Control Trial

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by University of Pennsylvania.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01299883
First received: February 1, 2011
Last updated: February 17, 2011
Last verified: February 2011
History of Changes
  Purpose

The investigators will evaluate the effects of an integrated risk counseling program on behavioral and psychological outcomes in African American men and women in a randomized trial that is implemented and evaluated collaboratively through the West Philadelphia Consortium to Address Disparities. The specific aims of this research are as follows:

  1. To evaluate the effects of integrated versus disease specific counseling on risk exposure behaviors. The investigators predict that compared to individuals who receive disease specific counseling, those who receive integrated counseling will report greater intake of fruits and vegetables and increased rates of physical activity.
  2. To evaluate effects of integrated versus disease specific counseling on psychological outcomes. The investigators predict that compared to individuals who receive disease specific counseling, those who receive integrated counseling will report greater risk comprehension related to cancer and cardiovascular disease and will be more motivated to make behavioral changes.
  3. To identify the mechanisms through which integrated risk counseling leads to behavioral change. The investigators predict that changes in risk exposure behaviors (e.g., diet and physical activity) will be mediated by increased risk comprehension and self-efficacy for diet and physical activity.

Condition Intervention
Cancer
Cardiovascular Diseases
 Other: Integrated vs Non-integrated Risk Education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Official Title: West Philadelphia Consortium to Address Disparities

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Dietary and physical activity behaviors [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Exposure to program in terms of attendance [ Time Frame: 4 wks. ] [ Designated as safety issue: No ]

Estimated Enrollment: 850
Study Start Date: August 2008
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cancer and CVD Education
Participants receive education about both cancer and CVD risk factors and their relationship to dietary and physical activity health behaviors.
 Other: Integrated vs Non-integrated Risk Education
Integrated group receives education about risk factors for both cancer and CVD whereas the non-integrated group receives information about CVD only to assess differences in health behavior outcomes.
Active Comparator: CVD Education
Participants receive education about CVD risk factors and their relationship to dietary and physical activity health behaviors.
 Other: Integrated vs Non-integrated Risk Education
Integrated group receives education about risk factors for both cancer and CVD whereas the non-integrated group receives information about CVD only to assess differences in health behavior outcomes.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • African American
  • Age 18-75
  • Resident of Philadelphia

Exclusion Criteria:

  • Previous or current cancer diagnosis
  • Previous or current diagnosis of a CVD
  • Cognitive disorder
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01299883

Contacts
Contact: Benita L Weathers, MPH 215-746-7166 weathers@mail.med.upenn.edu
Contact: Stacey Brown, MS 215-746-7435 sdjbrown@mail.med.upenn.edu

Locations
United States, Pennsylvania
University of Pennsylvania Center for Community Based Research and Health Disparities Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Benita L Weathers, MPH     215-746-7166     weathers@mail.med.upenn.edu    
Contact: Stacey D Brown, MS     215-746-7435     sdjbrown@mail.med.upenn.edu    
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Chanita H Halbert, PhD University of Pennsylvania
  More Information

Publications:

Responsible Party: Chanita Hughes Halbert, PhD/Associate Professor, Psychiatry, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01299883     History of Changes
Other Study ID Numbers: 5R24MDOO1594-06
Study First Received: February 1, 2011
Last Updated: February 17, 2011
Health Authority: United States: Federal Government

Keywords provided by University of Pennsylvania:
Cancer
CVD
African American
 Health Education Intervention
Intervention RCT
Study focus is to examine the influence of health education regarding either CVD or CVD and cancer on health behaviors.

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013