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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Smartphone application

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Limburg
    • Hasselt, Limburg, Belgium, 3500
      • Jessa Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Owning a smartphone and able to use it
2. Written informed consent obtained
3. Starting cardiac rehabilitation
4. Coronary artery disease

Exclusion Criteria:

1. Special diet due to other reasons (eg. renal diet, pancreatic insufficiency diet)
2. Age <18 years old
3. Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group
Experimental: Intervention group	Device: Smartphone application; Smartphone application named "Signal", which connects patients and health providers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Values of self-efficacy (questionnaire of General Self-Efficacy Scale [GSE])	This scale has the extreme values of 10 (minimum) and 40 (maximum). Higher scores mean a better outcome.	Up to 3 months
Values of medication adherence (questionnaire of Identification of Medication Adherence Barriers [IMAB])	This scale has the extreme values of 30 (minimum) and 150 (maximum). Higher scores mean a worse outcome.	Up to 3 months
Values of quality of life (Health-related Quality of Life questionnaire [HeartQoL])	This scale has the extreme values of 0 (minimum) and 42 (maximum). Higher scores mean a better outcome.	Up to 3 months
Body weight (BW)		Up to 3 months
Body mass index (BMI)	Weight and height will be combined to report BMI in kg/m^2.	Up to 3 months

Collaborators and Investigators

• Sponsor: Jessa Hospital
• Investigators: Principal Investigator: Paul Dendale, Jessa Ziekenhuis VZW

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2021
• Primary Completion (Actual): August 1, 2022
• Study Completion (Actual): August 1, 2022

Study Registration Dates

• First Submitted: September 13, 2021
• First Submitted That Met QC Criteria: September 27, 2021
• First Posted (Actual): October 8, 2021

Study Record Updates

• Last Update Posted (Actual): September 7, 2022
• Last Update Submitted That Met QC Criteria: September 5, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Coronary Artery Disease; Secondary Prevention; Diet Therapy
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: 2020/171

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No