TeleDiet Study: The Impact of Dietary Education and Counseling With a Smartphone Application on Secondary Prevention of Coronary Artery Disease
TeleDiet Study: A Randomized Controlled Study Investigating the Impact of Dietary Education and Counseling With a Smartphone Application on Secondary Prevention of Coronary Artery Disease
1 other identifier
interventional
60
1 country
1
Brief Summary
Digital cardiology is gaining power in the field of preventive cardiology recently, and several trials have already shown good results of dietary therapy with digital cardiology. However, there has been no reports that showed effect of dietary counseling through digital cardiology for secondary prevention of coronary artery disease. TeleDiet study investigates the impact of dietary therapy with a smartphone application on the content of meals and metabolic parameters for patients with coronary artery disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable coronary-artery-disease
Started Mar 2021
Shorter than P25 for not_applicable coronary-artery-disease
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
March 17, 2021
CompletedFirst Submitted
Initial submission to the registry
September 13, 2021
CompletedFirst Posted
Study publicly available on registry
October 8, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2022
CompletedSeptember 7, 2022
April 1, 2022
1.4 years
September 13, 2021
September 5, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
MedDiet score (the Mediterranean diet score)
This score has the extreme values of 0 (minimum) and 55 (maximum). Higher scores mean a better outcome.
Up to 3 months
Secondary Outcomes (10)
Blood lipid tests (LDL-cholesterol [LDL-C], HDL-cholesterol [HDL-C], and triglyceride [TG])
Up to 3 months
Blood glycated hemoglobin (HbA1c) test
Up to 3 months
Blood creatinine (Cr) test
Up to 3 months
Parameters in the ergospirometer test (maximal oxygen consumption [VO2 max])
Up to 3 months
Parameters in the ergospirometer test (anaerobic threshold [AT])
Up to 3 months
- +5 more secondary outcomes
Study Arms (2)
Intervention group
EXPERIMENTALControl group
NO INTERVENTIONInterventions
Smartphone application named "Signal", which connects patients and health providers
Eligibility Criteria
You may qualify if:
- Owning a smartphone and able to use it
- Written informed consent obtained
- Starting cardiac rehabilitation
- Coronary artery disease
You may not qualify if:
- Special diet due to other reasons (eg. renal diet, pancreatic insufficiency diet)
- Age \<18 years old
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jessa Hospitallead
Study Sites (1)
Jessa Hospital
Hasselt, Limburg, 3500, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul Dendale
Jessa Ziekenhuis vzw
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2021
First Posted
October 8, 2021
Study Start
March 17, 2021
Primary Completion
August 1, 2022
Study Completion
August 1, 2022
Last Updated
September 7, 2022
Record last verified: 2022-04