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Randomized Trial of the Impact of Body Scanning and Intensive Behavioral Intervention on Behavioral Change and Health Outcomes

Primary Purpose

Coronary Disease, Behavior and Behavior Mechanisms, Hypertension

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Physician Body Scan Consultation with Behavioral Intervention
Sponsored by
Reengineering Healthcare Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Disease

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Men or women aged 35 and over who provide informed consent to participate including the baseline, interim, and follow-up clinic visits, as well as willingness to participate in the on-line intervention (if selected to be in that group) -

Exclusion Criteria:

Known cardiovascular disease, cancer, or any life-threatening or debilitating illness, including psychiatric illnesses, or significant difficulty with the English language that would preclude successful participation in the program

-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Behavioral Intervention arm

    Control Group

    Arm Description

    A behavioral intervention consisting of a physician body scan consultation with a radiologist which included viewing self imagery followed by an 18 month behavioral intervention which included educational modules covering: Responding to Stress More Effectively Enhancing the effects of Relaxation Nourishing your immune system Energizing your Body Welcoming Others and Strengthening Relationships

    No Intervention

    Outcomes

    Primary Outcome Measures

    Progression of Coronary Artery Calcium
    Coronary artery calcium (CAC) was assessed by a trained technologist with the Agatston score measured and volume score calculated, summed among the four major coronary arteries using conventional methods.

    Secondary Outcome Measures

    Epicardial and Thoracic fat volume (in cm3)
    The QFAT™ software was utilized to provide measures of epicardial and thoracic fat volume (in cm3) as described previously (20) in a subset of participants who had the required Dicom-archived CT scan data both pre and post intervention

    Full Information

    First Posted
    December 29, 2017
    Last Updated
    December 29, 2017
    Sponsor
    Reengineering Healthcare Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03392350
    Brief Title
    Randomized Trial of the Impact of Body Scanning and Intensive Behavioral Intervention on Behavioral Change and Health Outcomes
    Official Title
    Randomized Trial of the Impact of Body Scanning and Intensive Behavioral Intervention on Behavioral Change and Health Outcomes
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    June 15, 2012 (Actual)
    Primary Completion Date
    September 15, 2015 (Actual)
    Study Completion Date
    November 20, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Reengineering Healthcare Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    We evaluated the effectiveness of a combination of a comprehensive health assessment consisting of the combination of a screening full body scan employing graphic patient education and motivational techniques followed by intensive, individualized behavioral training and management program on improved adherence to beneficial lifestyle behaviors, as well as possibly reduced risk of disease.
    Detailed Description
    We initially enrolled 267 volunteer asymptomatic adults consisting of firefighters/police workers (n= 173), active military personnel (n= 57) and community college staff (n= 37). Subjects were randomized either to an intervention group or to usual care. The intervention group received The RENEW™ Program (www.therenewprogram.net) of lifestyle intervention as described below. A whole body CT scan was performed using a multidetector CT scan on all participants at baseline with the results discussed by a physician only in the intervention group, and after 2 years of follow-up a repeat scan was performed with a detailed evaluation of the results discussed by a physician with all participants (in part as a motivation to complete thestudy). This study was carried out in accordance with the recommendations of the Western Institutional Review Board with written informed consent from all subjects. All subjects gavewritten informed consent in accordance with the Declaration of Helsinki. The protocol wasapproved by the Western Institutional Review Board.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Coronary Disease, Behavior and Behavior Mechanisms, Hypertension, Hypercholesterolemia

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    One Control group one Intervention arm. The intervention group are the only subjects receiving a body scan consultation and behavioral intervention.
    Masking
    Investigator
    Masking Description
    The staff doing the end point assessment were blinded as to treatment assignment.
    Allocation
    Randomized
    Enrollment
    267 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Behavioral Intervention arm
    Arm Type
    Active Comparator
    Arm Description
    A behavioral intervention consisting of a physician body scan consultation with a radiologist which included viewing self imagery followed by an 18 month behavioral intervention which included educational modules covering: Responding to Stress More Effectively Enhancing the effects of Relaxation Nourishing your immune system Energizing your Body Welcoming Others and Strengthening Relationships
    Arm Title
    Control Group
    Arm Type
    Active Comparator
    Arm Description
    No Intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    Physician Body Scan Consultation with Behavioral Intervention
    Intervention Description
    The RENEW™ program consisted of 7 bi-monthly face-to-face web sessions over 16-18 weeks followed by an average of 15 monthly check-in sessions (maintenance) over 80 weeks.This included modules on responding to stress, enhancing effects of relaxation, nourishing theimmune system, physical activity, and social support.
    Primary Outcome Measure Information:
    Title
    Progression of Coronary Artery Calcium
    Description
    Coronary artery calcium (CAC) was assessed by a trained technologist with the Agatston score measured and volume score calculated, summed among the four major coronary arteries using conventional methods.
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    Epicardial and Thoracic fat volume (in cm3)
    Description
    The QFAT™ software was utilized to provide measures of epicardial and thoracic fat volume (in cm3) as described previously (20) in a subset of participants who had the required Dicom-archived CT scan data both pre and post intervention
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Men or women aged 35 and over who provide informed consent to participate including the baseline, interim, and follow-up clinic visits, as well as willingness to participate in the on-line intervention (if selected to be in that group) - Exclusion Criteria: Known cardiovascular disease, cancer, or any life-threatening or debilitating illness, including psychiatric illnesses, or significant difficulty with the English language that would preclude successful participation in the program -

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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