Community-based Approaches to Treating Hypertension and Colon Cancer Prevention

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

740 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2014-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypertension Colon Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Motivational Interviewing

Individuals in the motivational interviewing (MINT) arm of the study will receive telephone-based lifestyle interviewing for 6-months. Counseling will be aimed at modifying diet and/or physical activity behaviors associated with decreasing blood pressure.

Group Type EXPERIMENTAL

MINT

Intervention Type BEHAVIORAL

Motivational interviewing for lifestyle changes associated with treating hypertension

Patient Navigation

Participants in the patient navigation arm will receive patient navigation for colonoscopy.

Group Type EXPERIMENTAL

Patient Navigation

Intervention Type BEHAVIORAL

Patient navigation for colonoscopy.

PLUS

Both patient navigation for colorectal cancer screening and motivational interviewing for blood pressure control

Group Type EXPERIMENTAL

MINT

Intervention Type BEHAVIORAL

Motivational interviewing for lifestyle changes associated with treating hypertension

Patient Navigation

Intervention Type BEHAVIORAL

Patient navigation for colonoscopy.

Interventions

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MINT

Motivational interviewing for lifestyle changes associated with treating hypertension

Intervention Type BEHAVIORAL

Patient Navigation

Patient navigation for colonoscopy.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Participants must be age 50 years or older,
2. Self-identify as a black or African American male,
3. 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

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

Minimum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No