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NCT Number: NCT01092078

Community-based Approaches to Treating Hypertension and Colon Cancer Prevention

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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Key information

Conditions

Hypertension Cardiovascular Diseases Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Gastrointestinal Diseases Gastrointestinal Neoplasms Genetic Diseases, Inborn Intestinal Diseases Intestinal Neoplasms Multiple Endocrine Neoplasia Multiple Endocrine Neoplasia Type 1 Neoplasms Neoplasms by Site Neoplasms, Multiple Primary Neoplastic Syndromes, Hereditary Vascular Diseases

Age range

50 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

NYU School of Medicine

New York, 10010, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

MINT

Behavioral

Motivational interviewing for lifestyle changes associated with treating hypertension

Patient Navigation

Behavioral

Patient navigation for colonoscopy.

Primary outcomes

  1. 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.

  2. 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 outcomes

  1. Medication Adherence

    Time frame: 6-month follow-up

    Medication adherence will be assessed using the 4-item Morisky Medication Adherence scale.

  2. Physical Activity

    Time frame: 6-month follow-up

    Physical activity will be measured using the International Physical Activity Questionnaire (IPAQ).

  3. Intrinsic Motivation to Exercise

    Time frame: 6-month Follow-up

    Intrinsic motivation will be assessed using a 17-item questionnaire.

  4. Self-Efficacy (Exercise)

    Time frame: 6-month follow-up

    Self-efficacy related to exercise will be measured using a 12-iten questionnaire.

  5. Dietary Intake

    Time frame: 6-month follow-up

    Dietary intake will be assessed using the Food Frequency Questionnaire.

  6. Intrinsic Motivation (Diet)

    Time frame: 6-month follow-up

    Intrinsic motivation relating to diet will be assessed using a 17-item scale.

  7. Self-efficacy (Diet)

    Time frame: 6-month follow-up

    Self-efficacy relating to diet will be assessed using a 10-item scale.

  8. 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.

  9. 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.

  10. 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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • Cornell University
  • Wayne State University

Registry information

Acronym: MISTER-B

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Mar 24, 2010
Registry last updated
Apr 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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