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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01092078
First Posted: March 24, 2010
Last Update Posted: April 22, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Cornell University
Wayne State University
Information provided by (Responsible Party):
Joseph E. Ravenell, MD, MS, New York University School of Medicine
  Purpose
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.

Condition Intervention
Hypertension Colon Cancer Behavioral: MINT Behavioral: Patient Navigation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Community-based Approaches to Treating Hypertension and Colon Cancer Prevention

Further study details as provided by Joseph E. Ravenell, MD, MS, New York University School of Medicine:

Primary Outcome Measures:
  • 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.

  • 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.


Secondary Outcome Measures:
  • Medication Adherence [ Time Frame: 6-month follow-up ]
    Medication adherence will be assessed using the 4-item Morisky Medication Adherence scale.

  • Physical Activity [ Time Frame: 6-month follow-up ]
    Physical activity will be measured using the International Physical Activity Questionnaire (IPAQ).

  • Intrinsic Motivation to Exercise [ Time Frame: 6-month Follow-up ]
    Intrinsic motivation will be assessed using a 17-item questionnaire.

  • Self-Efficacy (Exercise) [ Time Frame: 6-month follow-up ]
    Self-efficacy related to exercise will be measured using a 12-iten questionnaire.

  • Dietary Intake [ Time Frame: 6-month follow-up ]
    Dietary intake will be assessed using the Food Frequency Questionnaire.

  • Intrinsic Motivation (Diet) [ Time Frame: 6-month follow-up ]
    Intrinsic motivation relating to diet will be assessed using a 17-item scale.

  • Self-efficacy (Diet) [ Time Frame: 6-month follow-up ]
    Self-efficacy relating to diet will be assessed using a 10-item scale.

  • 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.

  • 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.

  • 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.


Enrollment: 740
Study Start Date: May 2010
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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).

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01092078


Locations
United States, New York
NYU School of Medicine
New York, New York, United States, 10010
Sponsors and Collaborators
New York University School of Medicine
Cornell University
Wayne State University
Investigators
Principal Investigator: Joseph Ravenell, MD, MS NYU School of Medicine
  More Information

Publications:
Responsible Party: Joseph E. Ravenell, MD, MS, Assistant Professor, New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01092078     History of Changes
Other Study ID Numbers: 09-0151
First Submitted: March 18, 2010
First Posted: March 24, 2010
Last Update Posted: April 22, 2015
Last Verified: April 2015

Keywords provided by Joseph E. Ravenell, MD, MS, New York University School of Medicine:
hypertension
colon cancer screening
african american
men
motivational interviewing
patient navigation

Additional relevant MeSH terms:
Hypertension
Colonic Neoplasms
Vascular Diseases
Cardiovascular Diseases
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases