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
|Condition or disease||Intervention/treatment||Phase|
|Hypertension Colon Cancer||Behavioral: MINT Behavioral: Patient Navigation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||740 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Community-based Approaches to Treating Hypertension and Colon Cancer Prevention|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||May 2014|
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.
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.
Both patient navigation for colorectal cancer screening and motivational interviewing for blood pressure control
Motivational interviewing for lifestyle changes associated with treating hypertensionBehavioral: Patient Navigation
Patient navigation for colonoscopy.
- 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.
- 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.
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
|United States, New York|
|NYU School of Medicine|
|New York, New York, United States, 10010|
|Principal Investigator:||Joseph Ravenell, MD, MS||NYU School of Medicine|