TeleDiet Study: The Impact of Dietary Education and Counseling With a Smartphone Application on Secondary Prevention of Coronary Artery Disease

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: Smartphone application

• Registration Number: NCT05071495
• Lead Sponsor: Jessa Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-17
• Study First Submitted: 2021-09-13
• Study First Submitted QC: 2021-09-27
• Study First Posted: 2021-10-08
• Status Verified: 2022-04
• Primary Completion: 2022-08-01
• Study Completion: 2022-08-01
• Last Update Submitted: 2022-09-05
• Last Update Posted: 2022-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Smartphone application	-

Primary Outcome Measures

Name	Time	Method
MedDiet score (the Mediterranean diet score)	Up to 3 months	This score has the extreme values of 0 (minimum) and 55 (maximum). Higher scores mean a better outcome.

Secondary Outcome Measures

Name	Time	Method
Blood glycated hemoglobin (HbA1c) test	Up to 3 months
Values of self-efficacy (questionnaire of General Self-Efficacy Scale [GSE])	Up to 3 months	This scale has the extreme values of 10 (minimum) and 40 (maximum). Higher scores mean a better outcome.
Values of quality of life (Health-related Quality of Life questionnaire [HeartQoL])	Up to 3 months	This scale has the extreme values of 0 (minimum) and 42 (maximum). Higher scores mean a better outcome.
Parameters in the ergospirometer test (anaerobic threshold [AT])	Up to 3 months
Values of medication adherence (questionnaire of Identification of Medication Adherence Barriers [IMAB])	Up to 3 months	This scale has the extreme values of 30 (minimum) and 150 (maximum). Higher scores mean a worse outcome.
Blood lipid tests (LDL-cholesterol [LDL-C], HDL-cholesterol [HDL-C], and triglyceride [TG])	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
Body weight (BW)	Up to 3 months
Body mass index (BMI)	Up to 3 months	Weight and height will be combined to report BMI in kg/m\^2.

Trial Locations

Locations (1)

Jessa Hospital; 🇧🇪 Hasselt, Limburg, Belgium