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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.)

Trial design

Design model

Sequential

Treatments tested in this trial

  • Promoting a Healthy Lifestyle through Digital Support Tools (Nutrida and Gamebus)

    Behavioral

    The intervention to promote a healthy lifestyle, through counseling activities combined with Digital Support Tools (Nutrida and Gamebus), will be prescribed by all partecipants

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: All subjectsOther 1 intervention

Trial outcomes

Primary outcomes

1

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

Adherence will be measured between weeks 12 and 24 through the following criteria: dropout rate \<5%, daily use of each app \>5 minutes, \>2 daily log-ins per app, and \>4 weekly tasks completed in the "Gamebus" app.

Time frame
Between weeks 12 and 24 from the enrollment

Secondary outcomes

1

Effect of the Integrated Digital Intervention on Adherence to a Healthy Dietary Pattern

The effect of the intervention on dietary adherence will be evaluated through changes in Mediterranean diet adherence assessed via MEDAS score categories

Time frame
At weeks 12 and 24
2

Effect of the Integrated Digital Intervention on Physical Activity

The effect on physical activity will be evaluated by the number of participants with age-normative handgrip strength (in kg) values being equal to or greater than baseline.

Time frame
At weeks 12 and 24
3

Effect of the Integrated Intervention on Body Composition and Anthropometric Parameters

Variations in fat mass (%)

Time frame
At baseline, 12 week, and 24 week.
4

Effect of the Integrated Intervention on Glycolipid Metabolic Parameters

Changes in triglycerides (mg/dL)

Time frame
At baseline, 12 weeks, and 24 weeks.

Other outcomes

Sponsors and contacts

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