NCT01299883

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:

  1. 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. 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
543

participants targeted

Target at P75+ for not_applicable cancer

Timeline
Completed

Started Aug 2008

Longer than P75 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

February 1, 2011

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 18, 2011

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

October 11, 2017

Status Verified

October 1, 2017

Enrollment Period

8.7 years

First QC Date

February 1, 2011

Last Update Submit

October 10, 2017

Conditions

Keywords

CancerCVDAfrican AmericanHealth Education InterventionIntervention RCTStudy focus is to examine the influence of health education regarding either CVD or CVD and cancer on health behaviors.

Outcome Measures

Primary Outcomes (1)

  • Dietary and physical activity behaviors

    12 months

Secondary Outcomes (1)

  • Exposure to program in terms of attendance

    4 wks.

Study Arms (2)

Cancer and CVD Education

ACTIVE COMPARATOR

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

CVD Education

ACTIVE COMPARATOR

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

Other: Integrated vs Non-integrated Risk Education

Interventions

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 EducationCancer and CVD Education

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • African American
  • Age 18-75
  • Resident of Philadelphia

You may not qualify if:

  • Previous or current cancer diagnosis
  • Previous or current diagnosis of a CVD
  • Cognitive disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania Center for Community Based Research and Health Disparities

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (4)

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

NeoplasmsCardiovascular Diseases

Study Officials

  • Chanita H Halbert, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2011

First Posted

February 18, 2011

Study Start

August 1, 2008

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

October 11, 2017

Record last verified: 2017-10

Locations