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

• ClinicalTrials.gov Identifier: NCT04763772
• Recruitment Status: Recruiting
• First Posted: February 21, 2021
• Last Update Posted: April 18, 2023
• Sponsor: University Hospitals Cleveland Medical Center
• Information provided by (Responsible Party): Ian J. Neeland, MD, University Hospitals Cleveland Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Overweight and Obesity; PreDiabetes; Type 2 Diabetes; Cardiovascular Risk Factor	Diagnostic Test: Body Fat Distribution Imaging Report; Diagnostic Test: Basic Weight Information; Behavioral: Patient Provided; Behavioral: Physician Provided	Not Applicable

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).

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 140 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Clinical Effectiveness of Body Fat Distribution Imaging in Real-World Practice: The BODY-REAL Study
• Actual Study Start Date: November 1, 2021
• Estimated Primary Completion Date: January 2025
• Estimated Study Completion Date: January 2025

Arms and Interventions

Arm	Intervention/treatment
Experimental: Detailed Report; 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; 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.
Placebo Comparator: Basic Weight Information; 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; Body weight and body mass index
Experimental: Patient Provided; Report provided directly to the patient.	Behavioral: Patient Provided; Body weight/fat distribution information will be provided directly to the patient
Placebo Comparator: Physician Provided; Report provided directly to the provider to translate/counsel the patient.	Behavioral: Physician Provided; Body weight/fat distribution information will be provided directly to the physician

Outcome Measures

Primary Outcome Measures :

1. Body weight [ Time Frame: 6 months ]
   kilograms
2. Waist circumference [ Time Frame: 6 months ]
   centimeters
3. Blood pressure [ Time Frame: 6 months ]
   mmHg
4. Body mass index [ Time Frame: 6 months ]
   kg/m2
5. Perception of Risk for Diabetes (RPS-DD). [ Time Frame: 6 months ]
   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. Perception of Heart Disease (PRHDS). [ Time Frame: 6 months ]
   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.
7. Motivation to Change Behaviors (TSRQ). [ Time Frame: 6 months ]
   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.
8. Global Physical Activity Questionnaire (GPAQ). [ Time Frame: 6 months ]

   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
9. Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool. [ Time Frame: 6 months ]
   This is a questionnaire regarding dietary intake and behaviors.
10. Medication Adherence (MARS). [ Time Frame: 6 months ]
    This is a questionnaire (yes/no) regarding medication adherence and tolerability.
11. Step counts by Actigraphy. [ Time Frame: 6 months ]
    This is a count of total steps. Total step counts (per day, averaged over 1 week) will be quantified.

Eligibility Criteria

• Ages Eligible for Study: 35 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Age ≥ 35 years
2. Able to provide informed consent
3. Overweight or Obese (BMI ≥25 kg/m2)

4. 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

5. 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:

1. 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.
2. Self-reported or clinically documented history of significant fluctuations (>5% change) in weight within 1 month prior to screening for this trial.
3. 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).
4. Surgery scheduled for the trial duration period, except for minor surgical procedures, at the discretion of the Investigator.
5. Language barrier, mental incapacity, unwillingness or inability to understand.
6. 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.
7. Unable to complete/tolerate magnetic resonance imaging (MRI) due to severe claustrophobia or metallic implants.
8. ≥2 no-shows to recruitment clinic within the 6 months prior to screening.

Contacts and Locations

Contacts

Contact: Ian Neeland, MD; 216-844-5965; ian.neeland@uhhospitals.org

Locations

United States, Ohio

University Hospitals Cleveland Medical Center; Recruiting

Cleveland, Ohio, United States, 44106

Contact: Ann Dever, RN 216-286-5038 ann.dever@uhhospitals.org

Contact: Heather Conger, RN 2162865038 Heather.Conger2@UHhospitals.org

Sponsors and Collaborators

University Hospitals Cleveland Medical Center

More Information

• Responsible Party: Ian J. Neeland, MD, Director, UH Center for Cardiovascular Prevention, University Hospitals Cleveland Medical Center
• ClinicalTrials.gov Identifier: NCT04763772
• Other Study ID Numbers: STUDY20201918
• First Posted: February 21, 2021
• Last Update Posted: April 18, 2023
• Last Verified: April 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: 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.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)
• Time Frame: Immediately after study publication for 2 years

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Additional relevant MeSH terms:

Overweight; Overnutrition; Nutrition Disorders; Body Weight