NCT07456332Enrolling by invitation
Effect on Body Weight Reduction of a Behavioral Intervention on Lifestyle Using a Digital Nutritional Program in People Living With HIV and Metabolic Dysfunction-associated Steatotic Liver Disease
Source: ClinicalTrials.gov · Last updated 10 Mar 2026
Brief summary (registry, in English)
Metabolic dysfunction-associated steatotic liver disease (MASLD) is now the leading cause of chronic liver disease in people living with HIV (PLWH). Currently, there are no approved medications to treat this condition. That's why weight loss through healthy lifestyle changes is the most important way to manage it. This study will test if a digital nutritional program (DNP), using a mobile phone app, can help improve weight loss better than the usual advice on healthy eating and exercise. The study includes people living with HIV, aged 18 and older, with fatty liver (detected by ultrasound or other scans), and on stable HIV treatment. Participants will be randomly assigned to two groups: * Intervention group: Will receive personalized lifestyle support through a mobile app (DNP). * Control group: Will receive general advice on healthy habits. The study will last 12 months, with follow-up visits during and after the program. What Will Be Measured: * Weight, waist size, blood pressure, and body fat. * Blood tests to check cholesterol, sugar levels, liver enzymes, and other markers. * Liver scans to assess fat and stiffness. * Questionnaires on eating habits, exercise, and satisfaction with the program. Goals of the Study: Main goal: To see how many people lose at least 5% of their body weight after 6 months. Other goals: To see the effects on weight after 12 months, and 6 months after stopping the program, and to monitor improvements in liver health. Why This Matters: This study aims to find new ways to help people with HIV improve their liver health and overall well-being through simple, practical tools like a mobile app.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 116 (estimated)
- First submitted
- 23 Jul 2025
- Start date
- Apr 2025
- Primary completion date
- Aug 2027
- Lead sponsor
- Hospital Universitari de Bellvitge
- Diseases
- HIV
- NCT number
- NCT07456332
What you commit to
- Study type: Interventional
- Planned participants: 116
- From Apr 2025 to the primary completion date, Aug 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Pharmacological treatment with immunosuppressants, cytotoxic agents, systemic corticosteroids, or other drugs that could potentially cause hepatic steatosis (amiodarone, tamoxifen, methotrexate) or alter liver tests
- The use of weight modifiers or previous weight loss surgery at any time
Other illness
- Presence of a condition that precluded modification of activity or diet behaviour
- Known liver disease other tan MASLD including viral, haemochromatosis, Wilson's Disease, alpha-1 antitripsin deficiency, autoimmune hepatitis and cirrhosis
- Endocrine disorders: hyperthyroidism or uncontrolled hypothyroidism
- Stage 4 and above kidney disease
- Active infection, cancer or autoimmune disease
Other
- Body mass index ≤ 23 kg/m2
- Excessive alcohol consumption (\>15 gr/day for women and 30 gr/day for men),
- Cardiovascular event in the last 6 months
- Inability to use an internet application or not having a Smartphone,
- Low command of spanish or illiteracy,
- Refusal to give informed consent
- Pregnant women or women planning pregnancy
Who the study is looking for
- HIV-infected patients
- ≥ 18 years of age
- On stable antiretroviral therapy during the last 6 months
- HIV viral load \<50 copies/ml for ≥ 6 months
- CD4 cell count \>200 cells/uL
- Diagnosis of liver steatosis on ultrasound or Controlled Attenuation Parameter (CAP) measured by vibration-controlled transient elastography
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitari de Bellvitge Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.