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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Detailed Report | Experimental | A 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. |
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| Basic Weight Information | Placebo Comparator | A 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. |
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| Patient Provided | Experimental | Report provided directly to the patient. |
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| Physician Provided | Placebo Comparator | Report provided directly to the provider to translate/counsel the patient. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Body Fat Distribution Imaging Report | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in BMI | Change in body mass index between groups | 6 months |
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Inclusion Criteria:
Age ≥ 35 years
Able to provide informed consent
Overweight or Obese (BMI ≥25 kg/m2)
Prediabetes or Type 2 Diabetes:
At least 1 additional cardiovascular risk factor (defined by Adult Treatment Panel III criteria2) including:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41245699 | Derived | 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. |
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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.
Immediately after study publication for 2 years
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| ID | Title | Description |
|---|---|---|
| FG000 | Detailed Report + Patient Provided | A detailed read-out of body fat and muscle quantitation and distribution including visceral fat, abdominal subcutaneous fat, and thigh muscle volumes in liters, and thigh muscle fat infiltration (%) and liver fat (%), all presented on a visual scale compared with reference data from a normative, metabolic disease-free population (derived from the UK Biobank). Report provided to the patient. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 30, 2019 |
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| Basic Weight Information | Diagnostic Test | Body weight and body mass index |
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| Patient Provided | Behavioral | Body weight/fat distribution information will be provided directly to the patient |
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| Physician Provided | Behavioral | Body weight/fat distribution information will be provided directly to the physician |
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| FG001 | Basic Weight Information + Patient | A 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. Basic Weight Information: Body weight and body mass index Report provided to the patient. |
| FG002 | Detailed Report + Doctor Provided | A detailed read-out of body fat and muscle quantitation and distribution including visceral fat, abdominal subcutaneous fat, and thigh muscle volumes in liters, and thigh muscle fat infiltration (%) and liver fat (%), all presented on a visual scale compared with reference data from a normative, metabolic disease-free population (derived from the UK Biobank). Report provided to medical professional. |
| FG003 | Basic Weight Information + Doctor Provided | A 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. Basic Weight Information: Body weight and body mass index Report provided to medical professional. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Detailed Report + Patient Provided | A detailed read-out of body fat and muscle quantitation and distribution including visceral fat, abdominal subcutaneous fat, and thigh muscle volumes in liters, and thigh muscle fat infiltration (%) and liver fat (%), all presented on a visual scale compared with reference data from a normative, metabolic disease-free population (derived from the UK Biobank). Report provided to the patient. |
| BG001 | Basic Weight Information + Patient | A 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. Basic Weight Information: Body weight and body mass index Report provided to the patient. |
| BG002 | Detailed Report + Doctor Provided | A detailed read-out of body fat and muscle quantitation and distribution including visceral fat, abdominal subcutaneous fat, and thigh muscle volumes in liters, and thigh muscle fat infiltration (%) and liver fat (%), all presented on a visual scale compared with reference data from a normative, metabolic disease-free population (derived from the UK Biobank). Report provided to medical professional. |
| BG003 | Basic Weight Information + Doctor Provided | A 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. Basic Weight Information: Body weight and body mass index Report provided to medical professional. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Body Mass Index | Mean | Standard Deviation | kg/m2 |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change in BMI | Change in body mass index between groups | Posted | Least Squares Mean | 95% Confidence Interval | kg/m2 | 6 months |
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6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Detailed Report + Patient Provided | A detailed read-out of body fat and muscle quantitation and distribution including visceral fat, abdominal subcutaneous fat, and thigh muscle volumes in liters, and thigh muscle fat infiltration (%) and liver fat (%), all presented on a visual scale compared with reference data from a normative, metabolic disease-free population (derived from the UK Biobank). Report provided to the patient. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG001 | Basic Weight Information + Patient | A 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. Basic Weight Information: Body weight and body mass index Report provided to the patient. | 0 | 8 | 0 | 8 | 0 | 8 |
| EG002 | Detailed Report + Doctor Provided | A detailed read-out of body fat and muscle quantitation and distribution including visceral fat, abdominal subcutaneous fat, and thigh muscle volumes in liters, and thigh muscle fat infiltration (%) and liver fat (%), all presented on a visual scale compared with reference data from a normative, metabolic disease-free population (derived from the UK Biobank). Report provided to medical professional. | 0 | 8 | 0 | 8 | 0 | 8 |
| EG003 | Basic Weight Information + Doctor Provided | A 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. Basic Weight Information: Body weight and body mass index Report provided to medical professional. | 0 | 7 | 0 | 7 | 0 | 7 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ian Neeland | UH Cleveland Medical Center | 216-844-5965 | ian.neeland@uhhospitals.org |
| Mar 21, 2025 |
| Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D011236 | Prediabetic State |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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