Usability and Feasibility of the NutriQuest Application

NCT ID: NCT05884489

Last Updated: 2023-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2022-10-12

Brief Summary

The study is a pilot study (phase 2) that includes a usability study (phase 1).

The aim of the study is to investigate the feasibility and usability of the healthy nutrition application and the effects on adherence to Modified Mediterranean diet, self-efficacy and nutrition knowledge among patients with cardiovascular disease in a cardiac rehabilitation setting. Furthermore, it studies the overall user experience when using the healthy nutrition application.

Detailed Description

The study can be divided in two phases, each one addressing a specific research question:

1. Usability: Is the developed healthy nutrition application user-friendly and does it seem motivating for cardiac patients in a cardiac rehabilitation setting to use the application to eat more healthily?

2. Pilot study: Is the developed healthy nutrition application feasible and acceptable for cardiac patients? Does the healthy nutrition application have an effect on adherence to Modified Mediterranean diet, self-efficacy and nutrition knowledge in cardiac patients in a cardiac rehabilitation setting and what is the user experience?

Conditions

Gamification; Nutrition; Behavior Change

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention group

Group Type: EXPERIMENTAL

A gamified smartphone app-based eating behaviour intervention

Intervention Type: BEHAVIORAL

All patients gained access to the healthy nutrition application and were encouraged to make full use of its feature, and they were also required to maintain a logbook through the application at home to follow-up on their diet. The intervention last for six weeks.

Interventions

A gamified smartphone app-based eating behaviour intervention

All patients gained access to the healthy nutrition application and were encouraged to make full use of its feature, and they were also required to maintain a logbook through the application at home to follow-up on their diet. The intervention last for six weeks.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• History of cardiovascular disease with or without intervention (PCI/CABG/conservative/pacemaker implantation/ablation)
• History of current or past cardiac rehabilitation in Jessa Hospital Hasselt
• Current treatment must require them to follow the Mediterranean diet plan
• Age ≥18 years
• Willing and physically able to follow a application-based healthy nutrition program and other study procedures in a six-week follow-up period
• Evidence of a personally signed and dated informed consent, indicating that the subject (or a legally-recognized representative) has been informed of all pertinent aspects of the study
• Possession of and/or able to use an Android based smartphone (version 6 or higher)
• Possession of internet connectivity
• Dutch speaking and understanding

Exclusion Criteria

• Pregnant females
• Combined with diabetes or severe kidney disease
• Participation in other cardiac rehabilitation program trials, focusing on diet outcome
• Current or recent participation in other technology-supported programs, even when not directly targeting nutrition
• Any condition which in the opinion of the investigator would make it unsafe or unsuitable for the patient to participate in this study or a life expectancy of less than six weeks based on investigators judgment

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hasselt University

OTHER

Sponsor Role: collaborator

Jessa Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cardiology Department, Jessa Hospital

Hasselt, Limburg, Belgium

Countries

Belgium

Other Identifiers

2022/058

Identifier Type: -

Identifier Source: org_study_id