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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

267 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-15

Study Completion Date

2015-11-20

Brief Summary

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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.

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Detailed Description

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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

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Coronary Disease Behavior and Behavior Mechanisms Hypertension Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

One Control group one Intervention arm. The intervention group are the only subjects receiving a body scan consultation and behavioral intervention.

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

The staff doing the end point assessment were blinded as to treatment assignment.

Study Groups

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Behavioral Intervention arm

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

Group Type ACTIVE_COMPARATOR

Physician Body Scan Consultation with Behavioral Intervention

Intervention Type BEHAVIORAL

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.

Control Group

No Intervention

Group Type ACTIVE_COMPARATOR

Physician Body Scan Consultation with Behavioral Intervention

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

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Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes