- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04763772
Clinical Effectiveness of Body Fat Distribution Imaging in Real-World Practice: The BODY-REAL Study (BODY-REAL)
Study Overview
Status
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ohio
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Cleveland, Ohio, United States, 44106
- University Hospitals Cleveland Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
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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.
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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.
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Body weight and body mass index
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Experimental: Patient Provided
Report provided directly to the patient.
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Body weight/fat distribution information will be provided directly to the patient
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Placebo Comparator: Physician Provided
Report provided directly to the provider to translate/counsel the patient.
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Body weight/fat distribution information will be provided directly to the physician
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body weight
Time Frame: 6 months
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kilograms
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6 months
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Waist circumference
Time Frame: 6 months
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centimeters
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6 months
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Blood pressure
Time Frame: 6 months
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mmHg
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6 months
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Body mass index
Time Frame: 6 months
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kg/m2
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6 months
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Perception of Risk for Diabetes (RPS-DD).
Time Frame: 6 months
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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.
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6 months
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Perception of Heart Disease (PRHDS).
Time Frame: 6 months
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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.
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6 months
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Motivation to Change Behaviors (TSRQ).
Time Frame: 6 months
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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.
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6 months
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Global Physical Activity Questionnaire (GPAQ).
Time Frame: 6 months
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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:
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6 months
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Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool.
Time Frame: 6 months
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This is a questionnaire regarding dietary intake and behaviors.
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6 months
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Medication Adherence (MARS).
Time Frame: 6 months
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This is a questionnaire (yes/no) regarding medication adherence and tolerability.
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6 months
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Step counts by Actigraphy.
Time Frame: 6 months
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This is a count of total steps.
Total step counts (per day, averaged over 1 week) will be quantified.
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6 months
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY20201918
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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