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West Philadelphia Consortium Randomized Control Trial

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ClinicalTrials.gov Identifier: NCT01299883
Recruitment Status : Completed
First Posted : February 18, 2011
Last Update Posted : October 11, 2017
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:

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 or disease Intervention/treatment Phase
Cancer Cardiovascular Disease (CVD) Other: Integrated vs Non-integrated Risk Education Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 543 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: West Philadelphia Consortium to Address Disparities
Study Start Date : August 2008
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Dietary and physical activity behaviors [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Exposure to program in terms of attendance [ Time Frame: 4 wks. ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01299883


Locations
United States, Pennsylvania
University of Pennsylvania Center for Community Based Research and Health Disparities
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Chanita H Halbert, PhD University of Pennsylvania