Healthsnap on Epicardial Adipose Tissue Study
HEATS
Effect of a Personalized Nutritional and Exercise Algorithm to Epicardial Fat in Patients With Obesity and Pre-Diabetes
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started Jun 2018
Typical duration for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2018
CompletedFirst Submitted
Initial submission to the registry
September 21, 2018
CompletedFirst Posted
Study publicly available on registry
September 25, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 10, 2020
CompletedSeptember 16, 2020
September 1, 2020
2.3 years
September 21, 2018
September 11, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Epicardial fat thickness (EAT)
Change in ultrasound measured EAT
3 months
Secondary Outcomes (2)
Body Mass Index (BMI)
3 months
Hemoglobin A1c (HbA1c) percentage (%)
3 months
Study Arms (2)
Healthsnap
EXPERIMENTAL50 patients will receive HealthSnap assessment in addition to their current treatment regardless of their participation into the study
Diet
ACTIVE COMPARATOR50 patients will receive standard of care dietary counselling in addition to their current treatment regardless of their participation into the study
Interventions
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
Dietary counseling by RD. Low Calorie and/or Low Carb dietary plans will be discussed and provided to the study participant
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Miami
Miami, Florida, 33136, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
September 21, 2018
First Posted
September 25, 2018
Study Start
June 1, 2018
Primary Completion
September 10, 2020
Study Completion
September 10, 2020
Last Updated
September 16, 2020
Record last verified: 2020-09