Clinical Effectiveness of Body Fat Distribution Imaging in Real-World Practice: The BODY-REAL Study

Summary

The overall goal is to determine the real-world feasibility and utility of body fat imaging using rapid MRI to enhance risk perception, induce behavioral change, and improve clinical outcomes in overweight and obese individuals. Here, the investigators will perform a pragmatic clinical effectiveness pilot trial using a 2x2 factorial design to test the hypothesis that provision of a detailed individualized visual report of body fat distribution directly to patients will translate into changes in patient risk perception, behavior, and improved clinical outcomes.

Conditions

• Overweight and Obesity
• PreDiabetes
• Type 2 Diabetes
• Cardiovascular Risk Factor

Interventions

DIAGNOSTIC_TEST

Body Fat Distribution Imaging Report

Those randomized to body fat distribution imaging will be scanned on a 1.5 Tesla Siemens Aera MRI scanner (Siemens, Erlangen, Germany), located in the Center for Advanced Heart and Vascular Care using a 6-minute dual-echo Dixon Vibe protocol providing a water and fat separated volumetric data set covering neck to knees, and a multiecho Dixon acquisition for proton density fat fraction assessment in the liver. Images of the liver will be acquired using a 16-channel SENSE extra large Torso coil and images from the rest of the body will be acquired using the body coil. Volumetric imaging datasets of the body derived by MRI will be generated and adipose tissue/fat depots will be quantified: abdominal subcutaneous compartment (ASAT), visceral compartment (VAT), and hips and buttocks (lower body fat); proton density fat fraction of the liver (i.e. hepatic steatosis) as well as the quality of lean (skeletal muscle) including muscle volume and degree of fat infiltration.

DIAGNOSTIC_TEST

Basic Weight Information

Body weight and body mass index

BEHAVIORAL

Patient Provided

Body weight/fat distribution information will be provided directly to the patient

BEHAVIORAL

Physician Provided

Body weight/fat distribution information will be provided directly to the physician

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

FACTORIAL

Eligibility

Min Age

35 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-11-01

Primary Completion

2024-07-31

Completion

2024-07-31

FDA Device

Yes

Countries

• United States

Study Locations