Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Change from Baseline in Cognitive Engagement at study end |
Cognitive engagement is measured using the Cognitive Activity Questionnaire (CAQ). Participants are asked to indicate the frequency in which they engage in 10 cognitive leisure activities. Scores range from 0 to 70. A higher score represents a higher cognitive engagement level. |
Baseline (within 1 week before the first coaching session) and study end (within 1 week after the last coaching session) |
|
Primary |
Change from Baseline in Mediterranean Diet Adherence at study end |
Adherence to the Mediterranean Diet is measured with an adaptation of the Canadian Mediterranean Diet Scale (MDS). The scale consists of 13 questions on food consumption frequency and intake habits. Scores range from 0 to 13, where a higher score represents a higher adherence level. |
Baseline (within 1 week before the first coaching session) and study end (within 1 week after the last coaching session) |
|
Primary |
Change from Baseline in Physical Activity at study end |
Physical activity level is measured using the International Physical Activity Questionnaire - Short Form (IPAQ-SF). The IPAQ-SF consists of 7 items to assess Moderate to vigorous physical activity (MVPA) as well as walking and sitting time in the last 7 days. An overall total physical activity score is computed in Metabolic equivalent tasks (MET)-minutes/week, where a higher MET value represents a higher level of physical activity. |
Baseline (within 1 week before the first coaching session) and study end (within 1 week after the last coaching session) |
|
Secondary |
Change from Baseline in Luci Cognitive Engagement Score at study end |
Six questions are added to the Cognitive Activity Questionnaire to include stimulating cognitive activities not covered in the original questionnaire. From the whole questionnaire, a total score is computed ranging from 0 to 112, where a higher score represents a higher cognitive engagement level. |
Baseline (within 1 week before the first coaching session) and study end (within 1 week after the last coaching session) |
|
Secondary |
Change from Baseline in Luci Mediterranean Diet Adherence Score at study end |
Eight questions are added to the Canadian Mediterranean Diet questionnaire to include food groups and food intake habits not covered in the original questionnaire. From the whole questionnaire, a total score is computed ranging from 0 to 36, where a higher score represents a higher adherence level. |
Baseline (within 1 week before the first coaching session) and study end (within 1 week after the last coaching session) |
|
Secondary |
Change from Baseline in Luci Physical Activity Score at study end |
Three questions assess frequency and intensity of specific physical activities related to aerobic, resistance and flexibility training over the past 7 days. Three subscores and a total score ranging from 0-30 are computed, where higher scores represent higher physical activity levels. |
Baseline (within 1 week before the first coaching session) and study end (within 1 week after the last coaching session) |
|
Secondary |
Goal Attainment |
For each goal, level of attainment and perceived effort towards goal attainment are rated weekly using a 10-point Likert-like scale, where 10 represents "completed" and "maximal effort", respectively. |
Weekly (within 1 week after the first coaching session) up to study end (within 1 week after the last coaching session) |
|
Secondary |
Perceived Progress in adopting lifestyle changes |
Perceived Progress in adopting lifestyle changes will be investigated with a single question, "To what extent do you think you changed your (domain specified) lifestyle since the beginning of the program?", using a 10-point Likert-like scale, where 10 represents a major change. |
Study end (within 1 week after the last coaching session) |
|
Secondary |
Change from Baseline in Readiness to change at study end |
Readiness to change will be determined using a 6-item questionnaire at Baseline and a 3-item questionnaire at study end. |
Baseline (within 1 week before the first coaching session) and study end (within 1 week after the last coaching session) |
|
Secondary |
Program Quality |
The quality of the program is assessed using the end-user version of the Mobile App Rating Scale (uMARS). The uMARS is a 20-item questionnaire that includes 4 objective quality subscales (engagement, functionality, aesthetics, and information quality), and 1 subjective quality subscale. A summary score is calculated as the mean score across the 4 objective criteria. One further subscale, consisting of 6 items, measures users' perceived impact of the evaluated app. Score range from 0-5, where 5 represents a higher quality and impact, respectively. |
Study end (within 1 week after the last coaching session) |
|
Secondary |
Program Usability |
The usability of the program is assessed using the System Usability Scale (SUS). The SUS is a 10-item questionnaire. Scores range from 0-5, where a higher score represents a higher usability. |
Study end (± 1 week after the last coaching session) |
|
Secondary |
Satisfaction and Continuance Usage Intention |
The user's continuance intention is assessed using the Satisfaction and Continuance Usage Intention Questionnaire. The questionnaire comprises 28 questions assessing 9 constructs, (Continuance intention, Expectation confirmation, Satisfaction, Perceived usefulness, Perceived ease of use, Trust/Credibility, Perceived security and confidentiality, Perceived service quality, Perceived system quality). Score range from 0-5, where a higher score represent a higher agreement, respectively. |
Study end (within 1 week after the last coaching session) |
|
Secondary |
Overall User Experience |
Feedback about the overall user experience with the platform will be collected using a semi-structured interview conducted by phone. |
Study end (within 1 week after the last coaching session) |
|
Secondary |
Platform usage |
Continuous measures of different parameters linked to platform usage during the study period will be recorded and analyzed, including pattern of use (e.g., time of day), frequency (e.g., number of platform access), duration of use (e.g., duration of the coach sessions) and the functionalities used (e.g., content viewed). |
Baseline (within 1 week before the first coaching session) to study end (within 1 week after the last coaching session) |
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