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

Reengineering Healthcare

Status: Completed

Conditions: Hypertension; Hypercholesterolemia; Coronary Disease; Behavior and Behavior Mechanisms

Treatments: Behavioral: Physician Body Scan Consultation with Behavioral Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03392350

20111268

Details and patient eligibility

About

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.

Full 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.

Enrollment: 267 patients

Sex: All

Ages: 35+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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267 participants in 2 patient groups

Behavioral Intervention arm

Active Comparator group

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

Treatment:

Behavioral: Physician Body Scan Consultation with Behavioral Intervention

Control Group

Active Comparator group

Description:

No Intervention

Treatment:

Behavioral: Physician Body Scan Consultation with Behavioral Intervention