West Philadelphia Consortium Randomized Control Trial

Overview

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.

Full Title of Study: “West Philadelphia Consortium to Address Disparities”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: April 2017

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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.
  • Active Comparator: CVD Education
    • Participants receive education about CVD risk factors and their relationship to dietary and physical activity health behaviors.

Clinical Trial Outcome Measures

Primary Measures

  • Dietary and physical activity behaviors
    • Time Frame: 12 months

Secondary Measures

  • Exposure to program in terms of attendance
    • Time Frame: 4 wks.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Pennsylvania
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Chanita H Halbert, PhD, Principal Investigator, University of Pennsylvania

Citations Reporting on Results

Halbert CH, Bellamy S, Bowman M, Briggs V, Delmoor E, Purnell J, Rogers R, Weathers B, Kumanyika S. Effects of integrated risk counseling for cancer and cardiovascular disease in African Americans. J Natl Med Assoc. 2010 May;102(5):396-402. doi: 10.1016/s0027-9684(15)30574-5.

Halbert CH, Kumanyika S, Bowman M, Bellamy SL, Briggs V, Brown S, Bryant B, Delmoor E, Johnson JC, Purnell J, Rogers R, Weathers B. Participation rates and representativeness of African Americans recruited to a health promotion program. Health Educ Res. 2010 Feb;25(1):6-13. doi: 10.1093/her/cyp057. Epub 2009 Oct 29.

Weathers B, Barg FK, Bowman M, Briggs V, Delmoor E, Kumanyika S, Johnson JC, Purnell J, Rogers R, Halbert CH. Using a mixed-methods approach to identify health concerns in an African American community. Am J Public Health. 2011 Nov;101(11):2087-92. doi: 10.2105/AJPH.2010.191775. Epub 2011 Feb 17.

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