West Philadelphia Consortium Randomized Control Trial

October 10, 2017 updated by: University of Pennsylvania

West Philadelphia Consortium to Address Disparities

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

543

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Center for Community Based Research and Health Disparities

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
ACTIVE_COMPARATOR: CVD Education
Participants receive education about CVD risk factors and their relationship to dietary and physical activity health behaviors.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dietary and physical activity behaviors
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Exposure to program in terms of attendance
Time Frame: 4 wks.
4 wks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (ACTUAL)

April 1, 2017

Study Completion (ACTUAL)

April 1, 2017

Study Registration Dates

First Submitted

February 1, 2011

First Submitted That Met QC Criteria

February 17, 2011

First Posted (ESTIMATE)

February 18, 2011

Study Record Updates

Last Update Posted (ACTUAL)

October 11, 2017

Last Update Submitted That Met QC Criteria

October 10, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5R24MDOO1594-06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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