Randomized Trial of the Impact of Body Scanning and Intensive Behavioral Intervention on Behavioral Change and Health Outcomes
- Conditions
- Behavior and Behavior MechanismsHypercholesterolemiaCoronary DiseaseHypertension
- Interventions
- Behavioral: Physician Body Scan Consultation with Behavioral Intervention
- Registration Number
- NCT03392350
- Lead Sponsor
- Reengineering Healthcare Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 267
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) -
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Group Physician Body Scan Consultation with Behavioral Intervention No Intervention Behavioral Intervention arm Physician Body Scan Consultation with Behavioral Intervention 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
- Primary Outcome Measures
Name Time Method Progression of Coronary Artery Calcium 2 years 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
Name Time Method Epicardial and Thoracic fat volume (in cm3) 2 years 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