West Philadelphia Consortium Randomized Control Trial

University of Pennsylvania

Status: Completed

Conditions: Cardiovascular Disease (CVD); Cancer

Treatments: Other: Integrated vs Non-integrated Risk Education

Study type: Interventional

Funder types: Other

Identifiers

NCT01299883

5R24MDOO1594-06

Details and patient eligibility

About

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.

Enrollment: 543 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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543 participants in 2 patient groups

Cancer and CVD Education

Active Comparator group

Description:

Participants receive education about both cancer and CVD risk factors and their relationship to dietary and physical activity health behaviors.

Treatment:

Other: Integrated vs Non-integrated Risk Education

CVD Education

Active Comparator group

Description:

Participants receive education about CVD risk factors and their relationship to dietary and physical activity health behaviors.

Treatment:

Other: Integrated vs Non-integrated Risk Education