Clinical Effectiveness of Body Fat Distribution Imaging in Real-World Practice: The BODY-REAL Study
BODY-REAL
1 other identifier
interventional
29
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2021
CompletedFirst Posted
Study publicly available on registry
February 21, 2021
CompletedStudy Start
First participant enrolled
November 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2024
CompletedResults Posted
Study results publicly available
March 25, 2025
CompletedMarch 25, 2025
March 1, 2025
2.7 years
February 4, 2021
March 4, 2025
March 21, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Change in BMI
Change in body mass index between groups
6 months
Study Arms (4)
Detailed Report
EXPERIMENTALA detailed body composition profile report that consists of the following elements: basic demographic data, percent body fat, weight to muscle ratio, visceral fat and abdominal subcutaneous fat volume, visceral fat ratio (the fraction of visceral divided by total abdominal fat), muscle fat infiltration and liver fat (%), and thigh muscle volumes (also separated into right and left, anterior and posterior compartments). Each parameter is presented on a visual scale in the context of the individual value, general population defined by reference data (from United Kingdom (UK) Biobank population), a metabolic disease-free population (also from UK Biobank), low/high and very low/very high, corresponding to 15th and 5th percentiles, respectively. There are also descriptions of each biomarker and how they are derived to provide context for the recipient.
Basic Weight Information
PLACEBO COMPARATORA simple informational report consisting of weight, BMI, and a visual representation of their BMI. This report also categorizes their BMI into underweight, normal weight, overweight, or obese categories according to the World Health Organization categorization schema.
Patient Provided
EXPERIMENTALReport provided directly to the patient.
Physician Provided
PLACEBO COMPARATORReport provided directly to the provider to translate/counsel the patient.
Interventions
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.
Body weight/fat distribution information will be provided directly to the patient
Body weight/fat distribution information will be provided directly to the physician
Eligibility Criteria
You may qualify if:
- Age ≥ 35 years
- Able to provide informed consent
- Overweight or Obese (BMI ≥25 kg/m2)
- Prediabetes or Type 2 Diabetes:
- Fasting glucose \>100 mg/dl, or
- Hb A1c \>5.7%, or
- Medical (i.e. pharmacologic) treatment for type 2 diabetes
- At least 1 additional cardiovascular risk factor (defined by Adult Treatment Panel III criteria2) including:
- Hypertension (BP\>130/80 or on medical therapy for hypertension)
- Low HDL-cholesterol (\<40 mg/dL in men and \<50 mg/dL in women)
- High triglycerides (\>150 mg/dL or on treatment for hypertriglyceridemia)
- Obstructive sleep apnea (clinical diagnosis)
- Coronary artery disease (clinical diagnosis)
- Congestive heart failure (clinical diagnosis)
- Atrial fibrillation (clinical diagnosis)
You may not qualify if:
- Receipt of any anti-obesity drug or supplement within 1 month prior to screening for this trial or plan to initiate therapy during the trial.
- Self-reported or clinically documented history of significant fluctuations (\>5% change) in weight within 1 month prior to screening for this trial.
- Current or history of treatment with medications that may cause significant weight gain, within 1 month prior to screening for this trial, including systemic corticosteroids (except for a short course of treatment, i.e., 7- 10 days), tri-cyclic antidepressants, atypical antipsychotic and mood stabilizers (e.g., imipramine, amitryptiline, mirtazapine, paroxetine, phenelzine, chlorpromazine, thioridazine, clozapine, olanzapine, valproic acid and its derivatives, and lithium).
- Surgery scheduled for the trial duration period, except for minor surgical procedures, at the discretion of the Investigator.
- Language barrier, mental incapacity, unwillingness or inability to understand.
- Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods. These include abstinence and the following methods: diaphragm with spermicide, condom with spermicide (by male partner), intrauterine device, sponge, spermicide, Norplant®, Depo-Provera® or oral contraceptives.
- Unable to complete/tolerate magnetic resonance imaging (MRI) due to severe claustrophobia or metallic implants.
- ≥2 no-shows to recruitment clinic within the 6 months prior to screening.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Related Publications (1)
Chhabria SM, Perez JA, Neeland IJ. Impact of an MRI Body Fat Imaging Report on Obesity-Related Cardiometabolic Risk: Findings From the BODY-REAL Study, A Randomized Trial. Obes Sci Pract. 2025 Nov 12;11(6):e70099. doi: 10.1002/osp4.70099. eCollection 2025 Dec.
PMID: 41245699DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Ian Neeland
- Organization
- UH Cleveland Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, UH Center for Cardiovascular Prevention
Study Record Dates
First Submitted
February 4, 2021
First Posted
February 21, 2021
Study Start
November 1, 2021
Primary Completion
July 31, 2024
Study Completion
July 31, 2024
Last Updated
March 25, 2025
Results First Posted
March 25, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Immediately after study publication for 2 years
Data generated from this proposed research application will be available to other researchers both internally at University Hospitals/Case Western Reserve University and externally at other institutions. All data will be free of identifiers that would permit linkages to individual research participants and variables that could lead to deductive disclosure of the identity of individual subjects. For external researchers, a similar procedure will be required in addition to signing a Data Use and Distribution Agreement per standard University policies and procedures. Data sharing will be in accordance with Institutional policies, local Institutional Review Board (IRB) rules, as well as local, state and Federal laws and regulations, including the HIPAA Privacy Rule.