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New treatment option for Liver Transplant
Official title Feasibility and Acceptability of a New Tool Promoting a Healthy Lifestyle in Liver and Kidney Transplant Recipients
ClinicalTrials.gov ID: NCT07305012
What this study is testing
- What it's testing
- 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.
- Time commitment: about 24 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- General physical conditions deemed by the investigator to contraindicate safe participation in any of the trial activities (e.g., blindness...
- 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...
See the full eligibility 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Bologna, BO, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 24 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bologna, BO, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.