Actively Recruiting
Feasibility and Acceptability of a New Tool for a Conscious Education and Motivation 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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether a doctor-led lifestyle counseling program, supported by two personalized smartphone apps called "Gamebus" and "Nutrida," is practical and helpful for improving healthy eating and physical activity in adults aged 65 years or older who have had a liver or kidney transplant. The study aims to see if participants can safely use these apps and follow the program, and whether this combined approach can improve diet, activity, body measurements, and routine lab values related to metabolic health. All participants first receive medical counseling on healthy diet and physical activity. After 12 weeks, they begin using the two digital support apps at home to help maintain behavior change. Each participant serves as their own comparison, with results after starting the apps compared to their own progress before using them. The intervention combines counseling activities with the use of these digital tools designed to promote a healthy lifestyle. Participants attend three study visits over 24 weeks. At each visit, they complete questionnaires, undergo body and body composition measurements, review their recent diet, and receive lifestyle guidance. The study team measures adherence to the digital lifestyle program between weeks 12 and 24 and also evaluates changes in diet, physical activity, body measurements, and metabolic lab tests at baseline, 12 weeks, and 24 weeks. The study helps determine if this digital-supported lifestyle program is feasible and acceptable for older transplant recipients.
CONDITIONS
Brief 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 60 years or older
- Liver or kidney transplant received at least 6 months and no more than 25 years ago
- Body mass index (BMI) between 21 and 29.9
- Signed informed consent
- Personal smartphone available
- Stable immunosuppressive therapy for the past 3 months
You will not qualify if you...
- Significant weight change (more than 5% of body weight) in the past 3 months
- 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 preventing safe participation (e.g., blindness, vertebral fractures, wheelchair dependence, home oxygen therapy)
- Dietary restrictions for ethical or religious reasons incompatible with study diet
- Active cancer under treatment or surgery, or cancer history within 5 years except hepatocellular carcinoma
- Psychiatric illnesses that may affect safety or adherence (e.g., schizophrenia, bipolar disorder, eating disorders)
- Recent changes in glucose-lowering or lipid-lowering medications within 90 days
- Participation in other lifestyle modification programs
- Any clinical condition the investigator considers unsafe or likely to affect study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 24 weeks
Participants receive counseling activities combined with digital support tools (Nutrida and Gamebus) to promote a healthy lifestyle.
Visits at baseline, week 12, and week 24 for assessments
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
M
Michele Stecchi, MD
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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