Community-based Approaches to Treating Hypertension and Colon Cancer Prevention (MISTER-B)
|ClinicalTrials.gov Identifier: NCT01092078|
Recruitment Status : Completed
First Posted : March 24, 2010
Last Update Posted : April 22, 2015
|Condition or disease||Intervention/treatment|
|Hypertension Colon Cancer||Behavioral: MINT Behavioral: Patient Navigation|
|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|
|Primary Completion Date :||May 2014|
|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.
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|