West Philadelphia Consortium Randomized Control Trial

NCT ID: NCT01299883

Last Updated: 2017-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

543 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2017-04-30

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:

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

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Conditions

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Cancer Cardiovascular Disease (CVD)

Keywords

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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.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Cancer and CVD Education

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

Group Type ACTIVE_COMPARATOR

Integrated vs Non-integrated Risk Education

Intervention Type OTHER

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.

CVD Education

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

Group Type ACTIVE_COMPARATOR

Integrated vs Non-integrated Risk Education

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chanita H Halbert, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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University of Pennsylvania Center for Community Based Research and Health Disparities

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 20533774 (View on PubMed)

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.

Reference Type RESULT
PMID: 19875730 (View on PubMed)

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.

Reference Type RESULT
PMID: 21330592 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28335038 (View on PubMed)

Other Identifiers

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5R24MDOO1594-06

Identifier Type: -

Identifier Source: org_study_id