GamificationNCT05884489
Usability and Feasibility of the NutriQuest Application
A study testing A gamified smartphone app-based eating behaviour intervention in people with Gamification and Nutrition, run by Jessa Hospital at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gamification, Nutrition, Behavior Change
- What is being tested?
- A gamified smartphone app-based eating behaviour intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jun 2022to 12 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Possession of and/or able to use an Android based smartphone (version 6 or higher)
- Possession of internet connectivity
- Dutch speaking and understanding
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gamified Smartphone Application to Improve the Adherence to the Mediterranean Diet in Cardiac Patients: a Usability and Feasibility Study
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.
Read the detailed description
The study can be divided in two phases, each one addressing a specific research question:
- 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?
- 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
- Being tested
- A gamified smartphone app-based eating behaviour intervention
- Keywords
- Gamification, Smartphone, Mediterranean diet, Nutrition, Cardiovascular diseases, Intervention
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A gamified smartphone app-based eating behaviour interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Behavioral: A gamified smartphone app-based eating behaviour intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability
The usability questionnaire asks patients to evaluate various components of the application based on perceived usefulness, ease of use and ease of understanding, as well as visual attractiveness and contains various questions specific to each component. The questionnaire includes 109 questions, we use 5-point Likert scale. The higher score means better usability.
Measured: Six week
Motivation
Motivation is measured by Intrinsic Motivation Inventory(IMI), it includes 18 items, we use 5-point Likert scale, the scores range from 18 to 90. Higher score means higher motivation.
Measured: Six week
Application visits
Usability is also measured by the objective index "application visits", the visits to each page/component of the application during the whole six week are recorded in the application.
Measured: During the whole six week
Acceptance
The acceptance is measured by Self-reported habit index(SRHI). It includes 12 items, we use 7-point Likert scale. Scores ranged from 12 to 84. The higher the score, the higher the acceptability.
Measured: Six week
Secondary outcomes (4)
Change from baseline Adherence to Mediterranean diet at 6 weeks
The adherence to Mediterranean diet is measured by Modified MedDietScore(MMDS), the MMDS we used in this study is an adaption of the MedDietScore in which parameters about salt and sugar intake are added to the score, and an intake of zero alcohol is considered positive (in contrast to the MedDietScore, which allows limited alcohol consumption), the higher score means better adherence to Mediterranean diet.
Measured: Baseline and six week
Change from Self-efficacy at 6 weeks
Self-efficacy is measured by "Nutrition self-efficacy scale", it includes five items, response format is (1) very uncertain, (2) rather uncertain, (3) rather certain, and (4) very certain. The higher the score indicates better self-efficacy.
Measured: Baseline and Six week
Change from Knowledge at 6 weeks
Knowledge is measured by "Nutrition knowledge score",the questionnaire contains 14 questions used to examine patients' knowledge about a healthy diet. Each question (e.g., what nutrients do not contain energy?) has four possible responses (e.g., proteins, alcohol, carbohydrates and minerals) and patients are expected to select the correct one. A question is worth one point, the higher the score indicates better nutrition knowledge.
Measured: Baseline and six week
Digital health literacy
The questionnaire includes five subscales (i.e. digital usage, digital skills, digital literacy, digital health literacy, and digital learnability) measured by 20 items that are answered on a 5-point Likert scale ranging from 1 to 5. Digital health literacy scores are calculated based on the sum of the four first subscales. The minimum score of the DHRQ is 15, and the maximum is 75. The score of digital learnability ranges from 5 to 25 and was categorized into 4 groups A (21-25), B (16-20), C (11-15), and D (5-10). Higher scores indicate greater willingness to learn about digital health tools. The result can be communicated as the total score + the letter from the digital learnability.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start1 Jun 2022
- Primary completion12 Oct 2022
- Study completion12 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GamificationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jessa Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hasselt University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05884489
- Sponsor's protocol ID
- 2022/058
- Status last verified
- May 2023
- First submitted
- 9 May 2023
- Last updated
- 1 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gamified Smartphone Application to Improve the Adherence to the Mediterranean Diet in Cardiac Patients: a Usability and Feasibility Study
- ClinicalTrials.gov ID
- NCT05884489
- Acronym / sponsor ID
- 2022/058
- Conditions
- Gamification, Nutrition, Behavior Change
- Keywords
- Gamification, Smartphone, Mediterranean diet, Nutrition, Cardiovascular diseases, Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Jessa HospitalUniversity, hospital or other
- Collaborators
- Hasselt University
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 12 Oct 2022 (actual)
- Study completion
- 12 Oct 2022 (actual)
- First posted
- 1 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
- 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?
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: A gamified smartphone app-based eating behaviour intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A gamified smartphone app-based eating behaviour interventionAll 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. | Behavioural | Intervention group |
Primary outcome
Usability
Time frame: Six week
The usability questionnaire asks patients to evaluate various components of the application based on perceived usefulness, ease of use and ease of understanding, as well as visual attractiveness and contains various questions specific to each component. The questionnaire includes 109 questions, we use 5-point Likert scale. The higher score means better usability.
Motivation
Time frame: Six week
Motivation is measured by Intrinsic Motivation Inventory(IMI), it includes 18 items, we use 5-point Likert scale, the scores range from 18 to 90. Higher score means higher motivation.
Application visits
Time frame: During the whole six week
Usability is also measured by the objective index "application visits", the visits to each page/component of the application during the whole six week are recorded in the application.
Acceptance
Time frame: Six week
The acceptance is measured by Self-reported habit index(SRHI). It includes 12 items, we use 7-point Likert scale. Scores ranged from 12 to 84. The higher the score, the higher the acceptability.
4 secondary outcomes
Change from baseline Adherence to Mediterranean diet at 6 weeks
Time frame: Baseline and six week
Change from Self-efficacy at 6 weeks
Time frame: Baseline and Six week
Change from Knowledge at 6 weeks
Time frame: Baseline and six week
Digital health literacy
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A gamified smartphone app-based eating behaviour intervention in people with Gamification and Nutrition, run by Jessa Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability (time frame: Six week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2023.