West Philadelphia Consortium Randomized Control Trial

Not Applicable

Completed

• Conditions: Cancer; Cardiovascular Disease (CVD)
• Interventions: Other: Integrated vs Non-integrated Risk Education

• Registration Number: NCT01299883
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2011-02-01
• Study First Submitted QC: 2011-02-17
• Study First Posted: 2011-02-18
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-10
• Last Update Posted: 2017-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 543

Inclusion Criteria

• African American
• Age 18-75
• Resident of Philadelphia

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Exclusion Criteria

• Previous or current cancer diagnosis
• Previous or current diagnosis of a CVD
• Cognitive disorder

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CVD Education	Integrated vs Non-integrated Risk Education	Participants receive education about CVD risk factors and their relationship to dietary and physical activity health behaviors.
Cancer and CVD Education	Integrated vs Non-integrated Risk Education	Participants receive education about both cancer and CVD risk factors and their relationship to dietary and physical activity health behaviors.

Primary Outcome Measures

Name	Time	Method
Dietary and physical activity behaviors	12 months

Secondary Outcome Measures

Name	Time	Method
Exposure to program in terms of attendance	4 wks.

Trial Locations

Locations (1)

University of Pennsylvania Center for Community Based Research and Health Disparities; 🇺🇸 Philadelphia, Pennsylvania, United States