Liver TransplantNCT07305012
Feasibility and Acceptability of a New Tool Promoting a Healthy Lifestyle in Liver and Kidney Transplant Recipients
A study testing Promoting a Healthy Lifestyle through Digital Support Tools (Nutrida and Gamebus) in people with Liver Transplant and Kidney Transplant, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Liver Transplant, Kidney Transplant
- What is being tested?
- Promoting a Healthy Lifestyle through Digital Support Tools (Nutrida and Gamebus)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 18 Aug 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 60 years
- Liver or kidney transplant received at least 6 months and no more than 25 years prior
- BMI between 21 and 29.9
- Signed informed consent
- Having a personal smartphone
- Stable immunosuppressive therapy in the past 3 months
Who cannot join
- Significant weight change (>5% of body weight) in the past 3 months
- Combined liver-kidney transplant
- Medical conditions requiring specific diets that may render adherence to the dietary recommendations of the trial unsafe (e.g., chronic kidney disease, inflammatory bowel disease, celiac disease, bariatric surgery, etc.)
- General physical conditions deemed by the investigator to contraindicate safe participation in any of the trial activities (e.g., blindness, vertebral fractures, wheelchair dependence, home oxygen therapy, etc.)
- Adherence to specific dietary regimens for ethical and/or religious reasons that are incompatible with the dietary recommendations of this trial
- Active malignant tumors currently under pharmacological treatment or awaiting surgical treatment (except cutaneous squamous cell carcinomas), or history of malignant tumors within the last 5 years, except for hepatocellular carcinoma
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- Psychiatric comorbidities deemed by the investigator to potentially compromise safety and/or adherence, thereby risking biasing the results (e.g., schizophrenia, bipolar disorder, eating disorders, etc.)
- Changes in glucose-lowering or lipid-lowering therapy during the 90 days prior to the enrollment visit
- Active participation in another research or non-research program aimed at lifestyle modification
- Any clinical condition, diagnosed or under diagnostic evaluation, that the investigator considers may compromise safety and/or a priori adherence to the intervention, with a potential risk of altering the study outcomes
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, BO, 40138
Lucia Brodosi, MD, +39 3285524214, lucia.brodosi2@aosp.bo.it
Michele Stecchi, MD, +39 3332533235, michele.stecchi@aosp.bo.it
About this study
Official title: Feasibility and Acceptability of a New Tool for a Conscious Education and Motivation Promoting a hEalthy LIfestyle in Liver and Kidney Transplant rEcipients
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.
Read more
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.
- Conditions
- Liver Transplant, Kidney Transplant
- Being tested
- Promoting a Healthy Lifestyle through Digital Support Tools (Nutrida and Gamebus)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Promoting a Healthy Lifestyle through Digital Support Tools (Nutrida and Gamebus)Behavioural
The intervention to promote a healthy lifestyle, through counseling activities combined with Digital Support Tools (Nutrida and Gamebus), will be prescribed by all partecipants
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Promoting a Healthy Lifestyle through Digital Support Tools (Nutrida and Gamebus) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Between weeks 12 and 24 from the enrollment
Secondary outcomes (4)
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
Measured: At weeks 12 and 24
Effect of the Integrated Digital Intervention on Physical Activity
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.
Measured: At weeks 12 and 24
Effect of the Integrated Intervention on Body Composition and Anthropometric Parameters
Variations in fat mass (%)
Measured: At baseline, 12 week, and 24 week.
Effect of the Integrated Intervention on Glycolipid Metabolic Parameters
Changes in triglycerides (mg/dL)
Measured: At baseline, 12 weeks, and 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start18 Aug 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lucia Brodosi, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07305012
- Sponsor's protocol ID
- ELITE-AOUBO-IT-1
- Other IDs
- 101080645
- Status last verified
- Dec 2025
- First submitted
- 24 Nov 2025
- Last updated
- 26 Dec 2025
- 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 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of a New Tool for a Conscious Education and Motivation Promoting a hEalthy LIfestyle in Liver and Kidney Transplant rEcipients
- ClinicalTrials.gov ID
- NCT07305012
- Acronym / sponsor ID
- ELITE-AOUBO-IT-1
- Conditions
- Liver Transplant, Kidney Transplant
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 18 Aug 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 26 Dec 2025 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All subjects | Other | Behavioral: Promoting a Healthy Lifestyle through Digital Support Tools (Nutrida and Gamebus)The intervention to promote a healthy lifestyle, through counseling activities combined with Digital Support Tools (Nutrida and Gamebus), will be prescribed by all partecipants |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 60 years
- Liver or kidney transplant received at least 6 months and no more than 25 years prior
- BMI between 21 and 29.9
- Signed informed consent
- Having a personal smartphone
Key exclusion criteria (10 listed)
- Significant weight change (>5% of body weight) in the past 3 months
- Combined liver-kidney transplant
- Medical conditions requiring specific diets that may render adherence to the dietary recommendations of the trial unsafe (e.g., chronic kidney disease, inflammatory bowel disease, celiac disease, bariatric surgery, etc.)
- General physical conditions deemed by the investigator to contraindicate safe participation in any of the trial activities (e.g., blindness, vertebral fractures, wheelchair dependence, home oxygen therapy, etc.)
- Adherence to specific dietary regimens for ethical and/or religious reasons that are incompatible with the dietary recommendations of this trial
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 |
|---|---|---|
| Promoting a Healthy Lifestyle through Digital Support Tools (Nutrida and Gamebus)The intervention to promote a healthy lifestyle, through counseling activities combined with Digital Support Tools (Nutrida and Gamebus), will be prescribed by all partecipants | Behavioural | All subjects |
Primary outcome
Adherence to a Personalized Digital-Mediated Lifestyle Intervention in Transplant Recipients Aged ≥65 Years
Time frame: Between weeks 12 and 24 from the enrollment
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.
4 secondary outcomes
Effect of the Integrated Digital Intervention on Adherence to a Healthy Dietary Pattern
Time frame: At weeks 12 and 24
Effect of the Integrated Digital Intervention on Physical Activity
Time frame: At weeks 12 and 24
Effect of the Integrated Intervention on Body Composition and Anthropometric Parameters
Time frame: At baseline, 12 week, and 24 week.
Effect of the Integrated Intervention on Glycolipid Metabolic Parameters
Time frame: At baseline, 12 weeks, and 24 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Promoting a Healthy Lifestyle through Digital Support Tools (Nutrida and Gamebus) in people with Liver Transplant and Kidney Transplant, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
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 6 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 26 Dec 2025. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lucia Brodosi, MD (+39 3285524214, lucia.brodosi@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to a Personalized Digital-Mediated Lifestyle Intervention in Transplant Recipients Aged ≥65 Years (time frame: Between weeks 12 and 24 from the enrollment). 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 26 Dec 2025.