NCT04763772

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: University Hospitals Cleveland Medical Center · Academic / Other
• Sex: All
• Age: 35 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Specific Aim 1: To compare the clinical effectiveness of communicating the body weight and BMI using a visual aid alone versus a detailed body fat distribution report including individualized images and values relative to normative data using a visual scale in a population of overweight and obese adults with prediabetes or type 2 diabetes and at least one additional cardiovascular disease risk factor. Hypothesis 1: Provision of a detailed body fat distribution report contextualized with information describing the relevance of each body fat parameter will be superior to provision of body weight/BMI information alone on risk perception, behavioral change (enhanced physical activity, dietary choices, and preventive provider practices and medication adherence), and clinical outcomes (reduction in weight and waist circumference, blood pressure, triglycerides, and glycosylated hemoglobin). Specific Aim 2: To compare the clinical effectiveness of communicating body fat information to the medical provider (with the intent that the provider interprets the data and translates it to the patient) versus communicating the body fat information directly to the patient. Hypothesis 2: Provision of body fat information directly to the patient will be superior to provision of the information to the provider on risk perception, behavioral change, and clinical outcomes (as assessed in Aim 1).

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-11-01
• Primary completion: 2024-07-31
• Completion: 2024-07-31
• First posted: 2021-02-21
• Last updated: 2025-03-25
• Results posted: 2025-03-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study