Feasibility and Acceptability of a New Tool Promoting a Healthy Lifestyle in Liver and Kidney Transplant Recipients
NCT ID: NCT07305012
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
60 participants
INTERVENTIONAL
2025-08-18
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SEQUENTIAL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
All subjects
The intervention to promote a healthy lifestyle, through counseling activities combined with Digital Support Tools (Nutrida and Gamebus), will be prescribed by all partecipants
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
60 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
IRCCS Azienda Ospedaliero-Universitaria di Bologna
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Lucia Brodosi
MD
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, BO, Italy
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Lucia Brodosi, MD
Role: primary
Michele Stecchi, MD
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
101080645
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
ELITE-AOUBO-IT-1
Identifier Type: -
Identifier Source: org_study_id