West Philadelphia Consortium Randomized Control Trial

Study Overview
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Brief Summary
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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: 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. 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. 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.

Official Title
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West Philadelphia Consortium to Address Disparities

Conditions
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Cancer, Cardiovascular Disease (CVD)

Intervention / Treatment
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* Other: Integrated vs Non-integrated Risk Education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cancer and CVD Education<br>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<br>* 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.<br>|
| Active Comparator: CVD Education<br>Participants receive education about CVD risk factors and their relationship to dietary and physical activity health behaviors. | Other: Integrated vs Non-integrated Risk Education<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dietary and physical activity behaviors |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exposure to program in terms of attendance |  | 4 wks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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.