Clinical trial NCT04763772: Clinical Effectiveness of Body Fat Distribution Imaging in Real-World Practice: The BODY-REAL Study
Official title: Clinical Effectiveness of Body Fat Distribution Imaging in Real-World Practice: The BODY-REAL Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
PreDiabetes
Type 2 Diabetes
Cardiovascular Risk Factor
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 29
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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).

Eligibility 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.

Primary outcomes:
measure: Change in BMI
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
Study officials:
References: