Clinical trial NCT05884489: Usability and Feasibility of the NutriQuest Application
Official title: Gamified Smartphone Application to Improve the Adherence to the Mediterranean Diet in Cardiac Patients: a Usability and Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gamification
Nutrition
Behavior Change
Keywords: Gamification
Smartphone
Mediterranean diet
Nutrition
Cardiovascular diseases
Intervention
Lead sponsor: Jessa Hospital
Sponsor class: OTHER
Collaborators: name: Hasselt University
First posted: 2023-06-01
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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?

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

Primary outcomes:
measure: Usability
timeFrame: Six week
measure: Motivation
timeFrame: Six week
measure: Application visits
timeFrame: During the whole six week
measure: Acceptance
timeFrame: Six week
Secondary outcomes:
measure: Change from baseline Adherence to Mediterranean diet at 6 weeks
timeFrame: Baseline and six week
measure: Change from Self-efficacy at 6 weeks
timeFrame: Baseline and Six week
measure: Change from Knowledge at 6 weeks
timeFrame: Baseline and six week
measure: Digital health literacy
timeFrame: Baseline
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Cardiology Department, Jessa Hospital
state: Limburg
Study officials:
References: