West Philadelphia Consortium Randomized Control Trial

• Sponsor: University of Pennsylvania (Other)
• Overall Status: Completed
• CT.gov ID: NCT01299883
• Collaborator: (none)
• Enrollment: 543
• Location: 1
• Arms: 2
• Duration (Months): 104
• Patients Per Site Per Month: 5.2

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• 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: Aug 1, 2008
• Actual Primary Completion Date: Apr 1, 2017
• Actual Study Completion Date: Apr 1, 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Dietary and physical activity behaviors [12 months]

Secondary Outcome Measures

1. Exposure to program in terms of attendance [4 wks.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT01299883
• Other Study ID Numbers: 5R24MDOO1594-06
• First Posted: Feb 18, 2011
• Last Update Posted: Oct 11, 2017
• Last Verified: Oct 1, 2017

• 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

Study Results

No Results Posted as of Oct 11, 2017