Doctor counseling plus smartphone apps to support healthy eating and activity after liver or kidney transplant
Feasibility and Acceptability of a New Tool for a Conscious Education and Motivation Promoting a hEalthy LIfestyle in Liver and Kidney Transplant rEcipients
NA · IRCCS Azienda Ospedaliero-Universitaria di Bologna · NCT07305012
This program tries whether doctor-delivered lifestyle counseling combined with two smartphone apps can help people aged 60 and older who had a liver or kidney transplant eat healthier and be more active.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna (other) |
| Locations | 1 site (Bologna, BO) |
| Trial ID | NCT07305012 on ClinicalTrials.gov |
What this trial studies
All participants first receive standardized medical counseling on healthy diet and physical activity and are followed for 12 weeks. After that, participants begin using two personalized smartphone apps (Gamebus and Nutrida) to support behavior change at home while continuing follow-up. Each participant serves as their own comparison, with outcomes before and after starting the apps compared within individuals. The primary focus is feasibility and acceptability (retention, daily app use, and completion of weekly tasks), with secondary measures including diet, physical activity, and body measurements.
Who should consider this trial
Good fit: People aged 60 or older who received a liver or kidney transplant 6 months to 25 years ago, have a BMI of 21–29.9, stable immunosuppression, a personal smartphone, and can give informed consent are the ideal candidates.
Not a fit: Patients with recent major weight change, combined liver-kidney transplant, medical conditions requiring special diets, significant physical limitations that prevent safe participation, incompatible religious/ethical diets, or active malignancy are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this combined counseling-and-app approach could make it easier for older transplant recipients to adopt and maintain healthier eating and activity habits, which may improve body composition and long-term health.
How similar studies have performed: Digital coaching and app-based interventions have shown modest benefits for diet and activity in general and some transplant groups, but this specific counselor-plus-app approach in older liver and kidney transplant recipients is relatively untested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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
Where this trial is running
Bologna, BO
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, BO, Italy (RECRUITING)
Study contacts
- Study coordinator: Lucia Brodosi, MD
- Email: lucia.brodosi@aosp.bo.it
- Phone: +39 3285524214
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Liver Transplant, Kidney Transplant