Clinical trial NCT01299883: West Philadelphia Consortium Randomized Control Trial
Official title: West Philadelphia Consortium to Address Disparities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Cardiovascular Disease (CVD)
Keywords: 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.
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2011-02-18
Enrollment: 543
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility 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

Primary outcomes:
measure: Dietary and physical activity behaviors
timeFrame: 12 months
Secondary outcomes:
measure: Exposure to program in terms of attendance
timeFrame: 4 wks.
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania Center for Community Based Research and Health Disparities
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Chanita H Halbert, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. 2010 Feb;25(1):6-13. doi: 10.1093/her/cyp057. Epub 2009 Oct 29.
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: 10.2105/AJPH.2010.191775. Epub 2011 Feb 17.
citation: Halbert CH, Bellamy S, Briggs V, Delmoor E, Purnell J, Rogers R, Weathers B, Johnson JC. A comparative effectiveness education trial for lifestyle health behavior change in African Americans. Health Educ Res. 2017 Jun 1;32(3):207-218. doi: 10.1093/her/cyx039.