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

Not Applicable

Completed

• Conditions: Overweight and Obesity; Type 2 Diabetes; PreDiabetes; Cardiovascular Risk Factor
• Interventions: Behavioral: Patient Provided; Diagnostic Test: Body Fat Distribution Imaging Report; Behavioral: Physician Provided; Diagnostic Test: Basic Weight Information

• Registration Number: NCT04763772
• Lead Sponsor: University Hospitals Cleveland Medical Center

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).

Study Timeline

• Study First Submitted: 2021-02-04
• Study First Submitted QC: 2021-02-18
• Study First Posted: 2021-02-21
• Study Start: 2021-11-01
• Primary Completion: 2024-07-31
• Study Completion: 2024-07-31
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-28
• Last Update Posted: 2024-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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)

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Patient Provided	Patient Provided	Report provided directly to the patient.
Detailed Report	Body Fat Distribution Imaging 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.
Physician Provided	Physician Provided	Report provided directly to the provider to translate/counsel the patient.
Basic Weight Information	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.

Primary Outcome Measures

Name	Time	Method
Perception of Heart Disease (PRHDS).	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.
Body mass index	6 months	kg/m2
Perception of Risk for Diabetes (RPS-DD).	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.
Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool.	6 months	This is a questionnaire regarding dietary intake and behaviors.
Body weight	6 months	kilograms
Waist circumference	6 months	centimeters
Blood pressure	6 months	mmHg
Motivation to Change Behaviors (TSRQ).	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.
Global Physical Activity Questionnaire (GPAQ).	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
Step counts by Actigraphy.	6 months	This is a count of total steps. Total step counts (per day, averaged over 1 week) will be quantified.
Medication Adherence (MARS).	6 months	This is a questionnaire (yes/no) regarding medication adherence and tolerability.

Trial Locations

Locations (1)

University Hospitals Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States