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

Primary Purpose

Overweight and Obesity, PreDiabetes, Type 2 Diabetes

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Body Fat Distribution Imaging Report

Basic Weight Information

Patient Provided

Physician Provided

About this trial

This is an interventional prevention trial for Overweight and Obesity

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University Hospitals Cleveland Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Detailed Report

Basic Weight Information

Patient Provided

Physician Provided

Arm Description

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.

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.

Report provided directly to the patient.

Report provided directly to the provider to translate/counsel the patient.

Outcomes

Primary Outcome Measures

Body weight

kilograms

Waist circumference

centimeters

Blood pressure

mmHg

Body mass index

kg/m2

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.

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.

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.

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

Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool.

This is a questionnaire regarding dietary intake and behaviors.

Medication Adherence (MARS).

This is a questionnaire (yes/no) regarding medication adherence and tolerability.

Step counts by Actigraphy.

This is a count of total steps. Total step counts (per day, averaged over 1 week) will be quantified.

Secondary Outcome Measures

Full Information

NCT ID

NCT04763772

First Posted

February 4, 2021

Last Updated

April 14, 2023

Sponsor

University Hospitals Cleveland Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT04763772

Brief Title

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

Acronym

BODY-REAL

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 1, 2021 (Actual)

Primary Completion Date

January 2025 (Anticipated)

Study Completion Date

January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Hospitals Cleveland Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. 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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Detailed Report

Arm Type

Experimental

Arm Description

Arm Title

Basic Weight Information

Arm Type

Placebo Comparator

Arm Description

Arm Title

Patient Provided

Arm Type

Experimental

Arm Description

Report provided directly to the patient.

Arm Title

Physician Provided

Arm Type

Placebo Comparator

Arm Description

Report provided directly to the provider to translate/counsel the patient.

Intervention Type

Diagnostic Test

Intervention Name(s)

Body Fat Distribution Imaging Report

Intervention Description

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.

Intervention Type

Diagnostic Test

Intervention Name(s)

Basic Weight Information

Intervention Description

Body weight and body mass index

Intervention Type

Behavioral

Intervention Name(s)

Patient Provided

Intervention Description

Body weight/fat distribution information will be provided directly to the patient

Intervention Type

Behavioral

Intervention Name(s)

Physician Provided

Intervention Description

Body weight/fat distribution information will be provided directly to the physician

Primary Outcome Measure Information:

Title

Body weight

Description

kilograms

Time Frame

6 months

Title

Waist circumference

Description

centimeters

Time Frame

6 months

Title

Blood pressure

Description

mmHg

Time Frame

6 months

Title

Body mass index

Description

kg/m2

Time Frame

6 months

Title

Perception of Risk for Diabetes (RPS-DD).

Description

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.

Time Frame

6 months

Title

Perception of Heart Disease (PRHDS).

Description

Time Frame

6 months

Title

Motivation to Change Behaviors (TSRQ).

Description

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.

Time Frame

6 months

Title

Global Physical Activity Questionnaire (GPAQ).

Description

Time Frame

6 months

Title

Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool.

Description

This is a questionnaire regarding dietary intake and behaviors.

Time Frame

6 months

Title

Medication Adherence (MARS).

Description

This is a questionnaire (yes/no) regarding medication adherence and tolerability.

Time Frame

6 months

Title

Step counts by Actigraphy.

Description

This is a count of total steps. Total step counts (per day, averaged over 1 week) will be quantified.

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ian Neeland, MD

Phone

216-844-5965

ian.neeland@uhhospitals.org

Facility Information:

Facility Name

University Hospitals Cleveland Medical Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ann Dever, RN

Phone

216-286-5038

ann.dever@uhhospitals.org

First Name & Middle Initial & Last Name & Degree

Heather Conger, RN

Phone

2162865038

Heather.Conger2@UHhospitals.org

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

IPD Sharing Time Frame

Immediately after study publication for 2 years

Learn more about this trial

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

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