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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Overweight and Obesity, PreDiabetes, Type 2 Diabetes, Cardiovascular Risk Factor

Intervention / Treatment
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* Diagnostic Test: Body Fat Distribution Imaging Report
* Diagnostic Test: Basic Weight Information
* Behavioral: Patient Provided
* Behavioral: Physician Provided


Participation Criteria
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Eligibility Criteria
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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: 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) Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Detailed Report<br>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. | Diagnostic Test: Body Fat Distribution Imaging Report<br>* 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.<br>|
| Placebo Comparator: Basic Weight Information<br>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. | Diagnostic Test: Basic Weight Information<br>* Body weight and body mass index<br>|
| Experimental: Patient Provided<br>Report provided directly to the patient. | Behavioral: Patient Provided<br>* Body weight/fat distribution information will be provided directly to the patient<br>|
| Placebo Comparator: Physician Provided<br>Report provided directly to the provider to translate/counsel the patient. | Behavioral: Physician Provided<br>* Body weight/fat distribution information will be provided directly to the physician<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight | kilograms | 6 months | 
| Waist circumference | centimeters | 6 months | 
| Blood pressure | mmHg | 6 months | 
| Body mass index | kg/m2 | 6 months | 
| Perception of Risk for Diabetes (RPS-DD). | This is a survey questionnaire with responses corresponding to a number. The total score is the sum of all the responses. Min=22, Max=96. Lower scores denote greater perception of risk. | 6 months | 
| Perception of Heart Disease (PRHDS). | This is a survey questionnaire with responses corresponding to a number. The total score is the sum of all the responses. Min=20, Max=80. Higher scores denote greater perception of risk of getting heart disease. | 6 months | 
| Motivation to Change Behaviors (TSRQ). | This is a survey questionnaire with responses corresponding to a number. The total score is the sum of all the responses. Min=50, Max=350. Lower scores denote less treatment self-regulation. | 6 months | 
| Global Physical Activity Questionnaire (GPAQ). | The Global Physical Activity Questionnaire was developed by WHO for physical activity surveillance in countries. It collects information on physical activity participation in three settings (or domains) as well as sedentary behaviour, comprising 16 questions (P1-P16). The domains are: Activity at work Travel to and from places Recreational activities | 6 months | 
| Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool. | This is a questionnaire regarding dietary intake and behaviors. | 6 months | 
| Medication Adherence (MARS). | This is a questionnaire (yes/no) regarding medication adherence and tolerability. | 6 months | 
| Step counts by Actigraphy. | This is a count of total steps. Total step counts (per day, averaged over 1 week) will be quantified. | 6 months |