Healthsnap on Epicardial Adipose Tissue Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to learn about the effectiveness of HealthSnap assessment, to reduce epicardial fat thickness. Excessive epicardial fat is associated with higher risk of developing diabetes and heart diseases. HealthSnap Assessment is a simple, quick and not invasive tool that will provide the patient with a personalized information nutritional and exercise plan.The use of HealthSnap in the clinical practice has not been evaluated, yet.

Detailed Description
-----------------
This study will evaluate the practicality of adding the HealthSnap algorithm to the standard care of patients with overweight/obesity and pre-diabetes. Participants will be recruited among the outpatient population who routinely refer to the Lennar Foundation Comprehensive Diabetes Center Outpatient Clinics, Division of Endocrinology, Diabetes and Metabolism University of Miami, for standard care and management of diabetes, obesity, overweight, hypertension, dyslipidemia. Once patient eligibility and written consent are obtained, participant is then scheduled for the clinic visit through the University of Miami UChart (Epic) electronic system. The visits will be coordinated by the research coordinator. At each visit each patient will undergo: Full physical examination, body weight, height, waist and hip circumference, blood pressure (standard of care) Fasting blood glucose and haemoglobinA1c (HbA1c), lipid panel, comprehensive metabolic panel, fasting insulin, C-peptide and pro-insulin (all procedures are standard of care) Ultrasound assesment of epicardial fat, performed on site HealthSnap assessment performed on site (if randomized to the group receiving additional Healthnap) Standard of care dietary counselling performed on site by a registered dietitian (if randomized to the control group) Study patients and controls will be contacted by the dietitian and/or HealthSnap supervisor once a week via telephone, or email (Uchart) or via online session (collaborate Ultra) to monitor their compliance and adherence to the exercise and dietary program.

Official Title
-----------------
Effect of a Personalized Nutritional and Exercise Algorithm to Epicardial Fat in Patients With Obesity and Pre-Diabetes

Conditions
-----------------
Obesity, Pre Diabetes

Intervention / Treatment
-----------------
* Behavioral: HealthSnap
* Behavioral: dietary counseling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body mass index (BMI) ≥ 27 kg/m2 HbA1c 5.7-6.5% within 3 months the initial visit and/or Fasting blood glucose (FBG) 100-125 mg/dl within 3 months the initial visit and/or Family history for diabetes or CAD or dyslipidemia Exclusion Criteria: • Type 1 diabetes Pregnancy Mental illness preventing correct use of HealthSnap Physical inability to follow HealthSnap recommendations Active infective and neoplastic diseases No current diabetes medications with the exception of Metformin Chemotherapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Open-label
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthsnap<br>50 patients will receive HealthSnap assessment in addition to their current treatment regardless of their participation into the study | Behavioral: HealthSnap<br>* HealthSnap provides personalized lifestyle reports and track progress over time using an electronic lifestyle record (ELR). HealthSnap Assessment is a simple, quick and not invasive tool that uses an algorithm that includes a questionnaire, physical measurements, dietary data and body fat indices<br>|
| Active Comparator: Diet<br>50 patients will receive standard of care dietary counselling in addition to their current treatment regardless of their participation into the study | Behavioral: dietary counseling<br>* Dietary counseling by RD. Low Calorie and/or Low Carb dietary plans will be discussed and provided to the study participant<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epicardial fat thickness (EAT) | Change in ultrasound measured EAT | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass Index (BMI) | Change in BMI | 3 months | 
| Hemoglobin A1c (HbA1c) percentage (%) | Change in the HbA1c % | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
epicardial fat