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

Summary

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.

Conditions

• Metabolic Dysfunction-Associated Steatotic Liver Disease
• People Living With HIV
• Life Style

Interventions

BEHAVIORAL

Digital nutritional program

* Web registration and download of the aplication: After signing the informed consent, the investigator will pre-register the participant on a page provided for this purpose. The patient will then receive an email with instructions to registre and download the digital nutritional program The user's pasword will be stored encrypted. Once received, the participant must fill out the start form. This form has the mission of conducting the dietitian-nutritionist on eating habits and lifestyles and to guide nutritional intervention. * Digital nutritional program: apply cognitive-behavioural techniques to promote healthy eating for each participant and ensure their understanding of the most important aspects for their Health, regarding their chronic conditions and the treatments they are undergoing. DNP will offer a program that tailors meal plans to patients' specific pathologies and circumstances via a mobile application.

BEHAVIORAL

Standard care dietary and exercice advice.

Advice on healthy lifestyle recommendations given by a trained physician or nurse, based on a Mediterranean diet (based on fruits, vegetables, legumes, whole grains, fish or white meat and olive oil; avoid processed foods, red meat and sugary drinks). Delivery of written resources containing healthy eating guidelines and advice.

Sponsors & Collaborators

• Institut d'Investigació Biomèdica de Bellvitge

  collaborator OTHER

• Gilead Sciences

  collaborator INDUSTRY

• Hospital Universitari de Bellvitge

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-04-23

Primary Completion

2027-08-31

Completion

2028-02-29

Countries

• Spain

Study Locations