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| Name | Class |
|---|---|
| Hasselt University | OTHER |
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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.
The study can be divided in two phases, each one addressing a specific research question:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A gamified smartphone app-based eating behaviour intervention | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | Six week |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiology Department, Jessa Hospital | Hasselt | Limburg | 3500 | Belgium |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| 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. | 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. | 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. | Baseline |