West Philadelphia Consortium Randomized Control Trial

The recruitment status of this study is unknown because the information has not been verified recently.

Verified February 2011 by University of Pennsylvania.
Recruitment status was Recruiting

Sponsor:

Information provided by:

University of Pennsylvania

ClinicalTrials.gov Identifier:

NCT01299883

First received: February 1, 2011

Last updated: February 17, 2011

Last verified: February 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

February 1, 2011

Last Updated Date

February 17, 2011

Start Date ^ICMJE

August 2008

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Dietary and physical activity behaviors [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01299883 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Exposure to program in terms of attendance [ Time Frame: 4 wks. ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

West Philadelphia Consortium Randomized Control Trial

Official Title ^ICMJE

West Philadelphia Consortium to Address Disparities

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:

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Condition ^ICMJE

Cancer
Cardiovascular Diseases

Intervention ^ICMJE

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.

Study Arm (s)

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.

Intervention: Other: Integrated vs Non-integrated Risk Education
Active Comparator: CVD Education
Participants receive education about CVD risk factors and their relationship to dietary and physical activity health behaviors.

Intervention: Other: Integrated vs Non-integrated Risk Education

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

850

Estimated Completion Date

June 2013

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Benita L Weathers, MPH	215-746-7166	weathers@mail.med.upenn.edu
Contact: Stacey Brown, MS	215-746-7435	sdjbrown@mail.med.upenn.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01299883

Other Study ID Numbers ^ICMJE

5R24MDOO1594-06

Has Data Monitoring Committee

Responsible Party

Chanita Hughes Halbert, PhD/Associate Professor, Psychiatry, University of Pennsylvania

Study Sponsor ^ICMJE

University of Pennsylvania

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Chanita H Halbert, PhD

University of Pennsylvania

Information Provided By

University of Pennsylvania

Verification Date

February 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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