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Clinical Trials/NCT01092078
NCT01092078
Completed
Not Applicable

Community-based Approaches to Treating Hypertension and Colon Cancer Prevention

NYU Langone Health1 site in 1 country740 target enrollmentMay 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypertension
Sponsor
NYU Langone Health
Enrollment
740
Locations
1
Primary Endpoint
Colon Cancer Screening Behavior
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

Black men constitute the demographic group with the greatest burden of premature death and disability from hypertension (HTN) in the United States. But while the disproportionately high rate of hypertension-related morbidity and mortality is well documented, the epidemic of colorectal cancer (CRC) among black men is comparatively under-appreciated. For example, CRC is a leading cause of cancer death in black men with a death rate 50% higher than in white men. Low rates of screening for CRC in this population contribute significantly to this problem. The purpose of this randomized controlled trial (RCT) is to evaluate the effect of a lifestyle intervention delivered through telephone-based motivational interviewing (MINT) versus a patient navigation intervention on blood pressure reduction and CRC screening.

Registry
clinicaltrials.gov
Start Date
May 2010
End Date
May 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Joseph E. Ravenell, MD, MS

Assistant Professor

NYU Langone Health

Eligibility Criteria

Inclusion Criteria

  • Participants must be age 50 years or older,
  • Self-identify as a black or African American male,
  • Have uncontrolled hypertension as defined by systolic blood pressure (SBP) \> 135 mmHg or diastolic blood pressure (DBP) \> 85 mmHg and SBP \> 130 or DBP \> 80 mmHg (in those with diabetes at the screening).

Exclusion Criteria

  • Inability to comply with the study protocol (either self-selected or by indicating during screening that he could not complete all requested tasks).

Outcomes

Primary Outcomes

Colon Cancer Screening Behavior

Time Frame: The outcome will be measured at 6-month follow-up

Whether or not the participant was screened for colon cancer between baseline and 6-month follow-up will be assessed using self-report and patient medical records.

Blood Pressure

Time Frame: Outcome is measured at 6-month follow-up

Three blood pressure measures and the average of the three measures will be obtained at baseline and 6-month follow-up using a Welch Allyn Vital Signs automated blood pressure monitor.

Secondary Outcomes

  • Medication Adherence(6-month follow-up)
  • Physical Activity(6-month follow-up)
  • Facilitators and Barriers to obtaining a colonoscopy(6-month follow-up)
  • Intrinsic Motivation to Exercise(6-month Follow-up)
  • Dietary Intake(6-month follow-up)
  • Behavioral Intention relating to colon cancer screening(6-month follow-up)
  • Self-Efficacy (Exercise)(6-month follow-up)
  • Intrinsic Motivation (Diet)(6-month follow-up)
  • Self-efficacy (Diet)(6-month follow-up)
  • Social Influence relating to colon cancer screening(6-month follow-up)

Study Sites (1)

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