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

September 5, 2022 updated by: Jessa Hospital

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
Time Frame: Up to 3 months
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])
Time Frame: Up to 3 months
Up to 3 months
Blood glycated hemoglobin (HbA1c) test
Time Frame: Up to 3 months
Up to 3 months
Blood creatinine (Cr) test
Time Frame: Up to 3 months
Up to 3 months
Parameters in the ergospirometer test (maximal oxygen consumption [VO2 max])
Time Frame: Up to 3 months
Up to 3 months
Parameters in the ergospirometer test (anaerobic threshold [AT])
Time Frame: Up to 3 months
Up to 3 months
Values of self-efficacy (questionnaire of General Self-Efficacy Scale [GSE])
Time Frame: Up to 3 months
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])
Time Frame: Up to 3 months
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])
Time Frame: Up to 3 months
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)
Time Frame: Up to 3 months
Up to 3 months
Body mass index (BMI)
Time Frame: Up to 3 months
Weight and height will be combined to report BMI in kg/m^2.
Up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jessa Hospital

Investigators

  • Principal Investigator: Paul Dendale, Jessa Ziekenhuis vzw

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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