NCT03683888

Healthsnap on Epicardial Adipose Tissue Study

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obesity
• Pre Diabetes

Interventions

Type	Name	Description
BEHAVIORAL	HealthSnap	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
BEHAVIORAL	dietary counseling	Dietary counseling by RD. Low Calorie and/or Low Carb dietary plans will be discussed and provided to the study participant

Timeline

• Start date: 2018-06-01
• Primary completion: 2020-09-10
• Completion: 2020-09-10
• First posted: 2018-09-25
• Last updated: 2020-09-16

Locations

1 site across 1 country: United States