RecruitingNot Applicable

Feasibility and Acceptability of a New Tool Promoting a Healthy Lifestyle in Liver and Kidney Transplant Recipients

Italy60 participantsStarted 2025-08-18

Plain-language 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. 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.

Who can participate

Age range

60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Adherence to a Personalized Digital-Mediated Lifestyle Intervention in Transplant Recipients Aged ≥65 Years

Timeframe: Between weeks 12 and 24 from the enrollment

Trial details

NCT IDNCT07305012

SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12

Contact for this trial

Lucia Brodosi, MD

+39 3285524214 lucia.brodosi@aosp.bo.it

View on ClinicalTrials.gov More Liver Transplant trials