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

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ClinicalTrials.gov Identifier: NCT01092078
Recruitment Status : Completed
First Posted : March 24, 2010
Last Update Posted : April 22, 2015
Sponsor:
Collaborators:
Cornell University
Wayne State University
Information provided by (Responsible Party):
Joseph E. Ravenell, MD, MS, NYU Langone Health

Tracking Information
First Submitted Date  ICMJE March 18, 2010
First Posted Date  ICMJE March 24, 2010
Last Update Posted Date April 22, 2015
Study Start Date  ICMJE May 2010
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 20, 2011)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 23, 2010)
  • 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 MicroLife 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.
Change History Complete list of historical versions of study NCT01092078 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2010)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Community-based Approaches to Treating Hypertension and Colon Cancer Prevention
Official Title  ICMJE Community-based Approaches to Treating Hypertension and Colon Cancer Prevention
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE
  • Hypertension
  • Colon Cancer
Intervention  ICMJE
  • Behavioral: MINT
    Motivational interviewing for lifestyle changes associated with treating hypertension
  • Behavioral: Patient Navigation
    Patient navigation for colonoscopy.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: MINT
  • Experimental: Patient Navigation
    Participants in the patient navigation arm will receive patient navigation for colonoscopy.
    Intervention: Behavioral: Patient Navigation
  • Experimental: PLUS
    Both patient navigation for colorectal cancer screening and motivational interviewing for blood pressure control
    Interventions:
    • Behavioral: MINT
    • Behavioral: Patient Navigation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 20, 2015)
740
Original Estimated Enrollment  ICMJE
 (submitted: March 23, 2010)
400
Actual Study Completion Date  ICMJE May 2014
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).

Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01092078
Other Study ID Numbers  ICMJE 09-0151
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Joseph E. Ravenell, MD, MS, NYU Langone Health
Study Sponsor  ICMJE NYU Langone Health
Collaborators  ICMJE
  • Cornell University
  • Wayne State University
Investigators  ICMJE
Principal Investigator: Joseph Ravenell, MD, MS NYU School of Medicine
PRS Account NYU Langone Health
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP