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| ID | Type | Description | Link |
|---|---|---|---|
| 101080645 | Other Grant/Funding Number | European Commission coordinated by Luxembourg Institute of Health Department of Precision Health |
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This interventional clinical trial tests whether a doctor-delivered lifestyle counseling program, supported by two personalized digital tools, is feasible and helpful for improving healthy eating and physical activity in older adults (65 years or older) who previously received a liver or kidney transplant.
All participants first receive medical counseling on healthy diet and physical activity. After 12 weeks, they begin using two smartphone apps ("Gamebus" and "Nutrida") designed to support behavior change at home. Each participant acts as their own comparison, and results after starting the apps are compared with their own results before using them.
The main goal is to find out whether participants can safely use the apps and follow the program (for example: staying in the study, using the apps daily, completing weekly tasks). The study also looks at whether the combined approach-counseling plus digital support-can help improve eating habits, physical activity, body measurements, and routine lab values related to metabolic health.
Participants attend three study visits over 24 weeks. At each visit, they complete questionnaires, undergo body measurements and body composition tests, review their recent diet, and receive lifestyle guidance. At the end, the study will help determine whether this digital-supported lifestyle program is practical and acceptable for older transplant recipients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All subjects | Other | The intervention to promote a healthy lifestyle, through counseling activities combined with Digital Support Tools (Nutrida and Gamebus), will be prescribed by all partecipants |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Promoting a Healthy Lifestyle through Digital Support Tools (Nutrida and Gamebus) | Behavioral | The intervention to promote a healthy lifestyle, through counseling activities combined with Digital Support Tools (Nutrida and Gamebus), will be prescribed by all partecipants |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to a Personalized Digital-Mediated Lifestyle Intervention in Transplant Recipients Aged ≥65 Years | Adherence will be measured between weeks 12 and 24 through the following criteria: dropout rate <5%, daily use of each app >5 minutes, >2 daily log-ins per app, and >4 weekly tasks completed in the "Gamebus" app. | Between weeks 12 and 24 from the enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of the Integrated Digital Intervention on Adherence to a Healthy Dietary Pattern | The effect of the intervention on dietary adherence will be evaluated through changes in Mediterranean diet adherence assessed via MEDAS score categories | At weeks 12 and 24 |
| Effect of the Integrated Digital Intervention on Physical Activity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lucia Brodosi, MD | Contact | +39 3285524214 | lucia.brodosi@aosp.bo.it | |
| Michele Stecchi, MD | Contact | +39 3332533235 | michele.stecchi@aosp.bo.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Azienda Ospedaliero-Universitaria di Bologna | Recruiting | Bologna | BO | 40138 | Italy |
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The effect on physical activity will be evaluated by the number of participants with age-normative handgrip strength (in kg) values being equal to or greater than baseline. |
| At weeks 12 and 24 |
| Effect of the Integrated Intervention on Body Composition and Anthropometric Parameters | Variations in fat mass (%) | At baseline, 12 week, and 24 week. |
| Effect of the Integrated Intervention on Glycolipid Metabolic Parameters | Changes in triglycerides (mg/dL) | At baseline, 12 weeks, and 24 weeks. |