West Philadelphia Consortium Randomized Control Trial

Cancer Clinical Trial

Official title:

West Philadelphia Consortium to Address Disparities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01299883
• Other study ID #: 5R24MDOO1594-06
• Status: Completed
• Phase: N/A
• First received: February 1, 2011
• Last updated: October 10, 2017
• Start date: August 2008
• Est. completion date: April 2017

Study information

• Verified date: October 2017
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 543
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Cardiovascular Disease (CVD)
• Cardiovascular Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	University of Pennsylvania Center for Community Based Research and Health Disparities	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. 2 — View Citation

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: 1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dietary and physical activity behaviors		12 months
Secondary	Exposure to program in terms of attendance		4 wks.