NCT03392350

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 267 (actual)
• Sponsor: Reengineering Healthcare Inc. · Academic / Other
• Sex: All
• Age: 35 Years
• Healthy volunteers: Accepted

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.

Conditions

• Coronary Disease
• Behavior and Behavior Mechanisms
• Hypertension
• Hypercholesterolemia

Interventions

Type	Name	Description
BEHAVIORAL	Physician Body Scan Consultation with Behavioral Intervention	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.

Timeline

• Start date: 2012-06-15
• Primary completion: 2015-09-15
• Completion: 2015-11-20
• First posted: 2018-01-05
• Last updated: 2018-01-05