Community-based Approaches to Treating Hypertension and Colon Cancer Prevention (MISTER-B)

April 20, 2015 updated by: Joseph E. Ravenell, MD, MS, NYU Langone Health
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

740

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
    • New York
      • New York, New York, United States, 10010
        • NYU School of Medicine

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

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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).

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

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: MINT
Motivational interviewing for lifestyle changes associated with treating hypertension
Experimental: Patient Navigation
Participants in the patient navigation arm will receive patient navigation for colonoscopy.
Behavioral: Patient Navigation
Patient navigation for colonoscopy.
Experimental: PLUS
Both patient navigation for colorectal cancer screening and motivational interviewing for blood pressure control
Behavioral: MINT
Motivational interviewing for lifestyle changes associated with treating hypertension
Behavioral: Patient Navigation
Patient navigation for colonoscopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Outcome is measured at 6-month follow-up
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.
The outcome will be measured at 6-month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medication Adherence
Time Frame: 6-month follow-up
Medication adherence will be assessed using the 4-item Morisky Medication Adherence scale.
6-month follow-up
Physical Activity
Time Frame: 6-month follow-up
Physical activity will be measured using the International Physical Activity Questionnaire (IPAQ).
6-month follow-up
Intrinsic Motivation to Exercise
Time Frame: 6-month Follow-up
Intrinsic motivation will be assessed using a 17-item questionnaire.
6-month Follow-up
Self-Efficacy (Exercise)
Time Frame: 6-month follow-up
Self-efficacy related to exercise will be measured using a 12-iten questionnaire.
6-month follow-up
Dietary Intake
Time Frame: 6-month follow-up
Dietary intake will be assessed using the Food Frequency Questionnaire.
6-month follow-up
Intrinsic Motivation (Diet)
Time Frame: 6-month follow-up
Intrinsic motivation relating to diet will be assessed using a 17-item scale.
6-month follow-up
Self-efficacy (Diet)
Time Frame: 6-month follow-up
Self-efficacy relating to diet will be assessed using a 10-item scale.
6-month follow-up
Facilitators and Barriers to obtaining a colonoscopy
Time Frame: 6-month follow-up
Facilitators and barriers to obtaining a colonoscopy will be assessed using a self-reported scale.
6-month follow-up
Behavioral Intention relating to colon cancer screening
Time Frame: 6-month follow-up
Behavioral intention to screen for colon cancer will be assessed using a self-reported scale.
6-month follow-up
Social Influence relating to colon cancer screening
Time Frame: 6-month follow-up
Social influence relating to colon cancer screening will be assessed using a self-reported questionnaire.
6-month follow-up

Collaborators and Investigators

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

Sponsor

NYU Langone Health

Collaborators

Wayne State University
Cornell University

Investigators

  • Principal Investigator: Joseph Ravenell, MD, MS, NYU School of Medicine

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

May 1, 2010

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

March 18, 2010

First Submitted That Met QC Criteria

March 23, 2010

First Posted (Estimate)

March 24, 2010

Study Record Updates

Last Update Posted (Estimate)

April 22, 2015

Last Update Submitted That Met QC Criteria

April 20, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-0151

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.

Subscribe