Actively Recruiting
Feasibility and Acceptability of a New Tool Promoting a Healthy Lifestyle in Liver and Kidney Transplant Recipients
Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-12-26
60
Participants Needed
1
Research Sites
67 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Feasibility and Acceptability of a New Tool Promoting a Healthy Lifestyle in Liver and Kidney Transplant Recipients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 20 years or older
- Received liver or kidney transplant at least 6 months and no more than 25 years ago
- Body mass index (BMI) between 21 and 29.9
- Signed informed consent
- Owns a personal smartphone
- Stable immunosuppressive therapy in the past 3 months
You will not qualify if you...
- Significant weight change (more than 5% of body weight) in the past 3 months
- Received combined liver-kidney transplant
- Medical conditions requiring specific diets that make study diet unsafe (e.g., chronic kidney disease, inflammatory bowel disease, celiac disease, bariatric surgery)
- Physical conditions that prevent safe participation (e.g., blindness, vertebral fractures, wheelchair dependence, home oxygen therapy)
- Following specific dietary regimens incompatible with study diet for ethical or religious reasons
- Active malignant tumors under treatment or awaiting surgery, or history of malignant tumors in last 5 years (except hepatocellular carcinoma and cutaneous squamous cell carcinomas)
- Psychiatric conditions that may affect safety or adherence (e.g., schizophrenia, bipolar disorder, eating disorders)
- Changes in glucose-lowering or lipid-lowering therapy within 90 days prior to enrollment
- Active participation in another lifestyle modification program
- Any clinical condition that may compromise safety or adherence as determined by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, BO, Italy, 40138
Actively Recruiting
Research Team
L
Lucia Brodosi, MD
CONTACT
M
Michele Stecchi, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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