Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Change in the overall mean satisfaction score of the Nutritional and Dietetic Patient Outcomes Questionnaire (NDPOQ) |
This outcome will evaluate the patient treatment satisfaction with the counselling of the "Personal Nutrition Advisor" (PNA) -assisted remote nutritional counselling. The NDPOQ includes a 5 point likert scale of agreement (5 points=strongly agree, 1 point= strongly disagree) of 15 questions. |
From baseline to 3 months of the respective study period |
|
| Primary |
The overall mean score of the "perceived impact" section from the user version of the mobile application scale (uMARS ) |
This outcome will evaluate patient satisfaction with the counselling of the "Personal Nutrition Advisor" (PNA) -assisted remote nutritional counselling. The uMARS includes a 5 point likert scale of agreement (5 points=strongly agree, 1 point= strongly disagree) of 5 questions. |
Post intervention visit (3 months after baseline) |
|
| Primary |
The overall mean score of the Healthcare Systems Usability Scale (HSUS) |
This outcome will evaluate dietitian reported usability of the "Personal Nutrition Advisor" (PNA)- assisted remote nutritional counselling. HSUS includes a 5 point likert scale of agreement (5 points=strongly agree, 1 point= strongly disagree) of 20 questions. |
Post intervention visit (3 months after baseline) |
|
| Secondary |
Change in self reported weight (%) |
This outcome will evaluate the potential to support weight loss by PNA-assisted remote nutritional counselling (self-reported weight closest to start and end of the study period). |
From baseline to 3 months of the respective study period |
|
| Secondary |
Proportion of patients reaching >5% weight loss |
This outcome will evaluate the potential to support weight loss by PNA-assisted remote nutritional counselling (calculated from the initial weight, measured in-clinic at start of the GLP-1 based pharmacotherapy) |
At start of the GLP-1 based pharmacotherapy to 3 months of the respective study period |
|
| Secondary |
Proportion of patients reaching >10% weight loss |
This outcome will evaluate the potential to support weight loss by PNA-assisted remote nutritional counselling (calculated from the initial weight, measured in-clinic at start of the GLP-1 based pharmacotherapy) |
At start of the GLP-1 based pharmacotherapy to 3 months of the respective study period |
|
| Secondary |
Proportion of patients reaching >15% weight loss |
This outcome will evaluate the potential to support weight loss by PNA-assisted remote nutritional counselling (calculated from the initial weight, measured in-clinic at start of the GLP-1 based pharmacotherapy) |
At start of the GLP-1 based pharmacotherapy to 3 months of the respective study period |
|
| Secondary |
Change in daily number of logged meals and beverages |
This outcome will evaluate the impact of PNA-assisted remote nutritional counselling on frequency of dietary self-monitoring (manual entries of pictures, text tags and food/beverage tags per day) |
From the first day of the respective study period to 3 months thereafter |
|
| Secondary |
Change in energy intake (kcal/day) |
This outcome will evaluate the impact of PNA-assisted remote nutritional counselling on PNA derived dietary intake, calculated by the energy balance model embedded in the PNA using manual entries of weight logs, meal logs and activity logs. |
From the first day of the respective study period to 3 months thereafter |
|
| Secondary |
Change in energy expenditure (kcal/day) |
This outcome will evaluate the impact of PNA-assisted remote nutritional counselling on PNA derived dietary expenditure, calculated by the energy balance model embedded in the PNA using manual entries of weight logs, meal logs and activity logs. |
From the first day of the respective study period to 3 months thereafter |
|
| Secondary |
Change in relative carbohydrate content (%) |
This outcome will evaluate the impact of PNA-assisted remote nutritional counselling on PNA derived nutrient distribution, calculated by the energy balance model embedded in the PNA using manual entries of weight logs, meal logs and activity logs. |
From the first day of the respective study period to 3 months thereafter |
|
| Secondary |
Change in relative protein content (%) |
This outcome will evaluate the impact of PNA-assisted remote nutritional counselling on PNA derived nutrient distribution, calculated by the energy balance model embedded in the PNA using manual entries of weight logs, meal logs and activity logs. |
From the first day of the respective study period to 3 months thereafter |
|
| Secondary |
Change in relative fat content (%) |
This outcome will evaluate the impact of PNA-assisted remote nutritional counselling on PNA derived nutrient distribution, calculated by the energy balance model embedded in the PNA using manual entries of weight logs, meal logs and activity logs. |
From the first day of the respective study period to 3 months thereafter |
|
| Secondary |
Change in relative fiber content (%) |
This outcome will evaluate the impact of PNA-assisted remote nutritional counselling on PNA derived nutrient distribution, calculated by the energy balance model embedded in the PNA using manual entries of weight logs, meal logs and activity logs. |
From the first day of the respective study period to 3 months thereafter |
|
| Secondary |
Change in self-reported exercise engagement per week (hours/week) |
This outcome will evaluate the impact of PNA-assisted remote nutritional counselling on self-reported physical activity using manual entries of activity logs. |
At baseline and at 3 months of study intervention |
|
| Secondary |
Change in the overall mean score of the General Self-efficacy Scale (GSE) from Imperial College London |
This outcome will evaluate the impact of PNA-assisted remote nutritional counselling on self-efficacy. GSE includes a 5 point Likert scale of confidence (Not at all confident =1 point, Extremely confident=5 points) of 6 questions. |
From baseline to 3 months of the respective study period |
|
| Secondary |
Collection of open ended PNA specific feedback questionnaires |
This qualitative outcome will collect opinions from patients and dietitians regarding the components of the PNA with the aim to further optimise its perceived usefulness. |
Post intervention visit (3 months after baseline) |
|
| Secondary |
Qualitative collection of patient reported PNA specific feedback. |
This qualitative outcome will be assessed by an semi structured remote patient group interview addressing the patient's perspective on the utility of the dietitians' advice, discrepancy from expectations, general feedback and suggestions for PNA improvement. |
Post intervention visit (3 months after baseline) |
|
