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

NCT07456332 | Enrolling By Invitation

• 1 other identifier: PR002/25
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief 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

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

Keywords

Metabolic dysfunction-associated steatotic liver disease; People living with HIV; Digital nutritional program; life style

Outcome Measures

Primary Outcomes (1)

• To compare the percentge of people living with HIV and MASLD achieving at least a 5% weight reduction at 6 months, through a randomly asigned behavioral intervention on lifestyle using a digital nutritional program or standard advice.

  Percentage of body weight change=( baseline body weight-6 month body weight/baseline body weight)×100. We will compare the percentage of participants who achieve a body weight reduction of ≥ 5% between the two arms, at month 6.

  From enrollment to month 6

Secondary Outcomes (19)

• To compare the percentage of participants who achieve at least a 5% reduction at 12 months

  From enrollment to month 12

• To assess maintenance of body weight 6 months after Digital Nutritional Program discontinuation.

  From month 12 to month 6 after Digital Nutritional Program discontinuation.

• To compare liver steatosis by vibration-controlled transient elastography at 12 months.

  From enrollment to month 12

• To compare liver stiffness by vibration-controlled transient elastography at 12 months.

  From enrollment to month 12

• To compare total cholesterol at 6 and 12 months, and 6 months after Digital Nutritional Program discontinuation

  From enrollment to month 6, 12 and 6 after Digital Nutritional Program discontinuation.

Study Arms (2)

Digital nutritional program

EXPERIMENTAL

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 These plans include detailed recipes, preparation instructions, and an automatic grocery list. Additionally, thematic weeks are incorporated, featuring training guides where patients engage system to address aspects related to their diet and enhance their health and wellbeing. All of these features are implemented within a gamified framework, with daily and weekly points awarded, and challenges incentivising adherence and motivation in their daily routines. The nutritional approach will be based on the Mediterranean diet.

Behavioral: Digital nutritional program

Standard care dietary and exercice advice

ACTIVE COMPARATOR

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.

Behavioral: Standard care dietary and exercice advice.

Interventions

Digital nutritional program BEHAVIORAL

* 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.

Digital nutritional program

Standard care dietary and exercice advice. BEHAVIORAL

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.

Standard care dietary and exercice advice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Body mass index ≤ 23 kg/m2
• 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
• Excessive alcohol consumption (\>15 gr/day for women and 30 gr/day for men),
• Endocrine disorders: hyperthyroidism or uncontrolled hypothyroidism
• 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
• Cardiovascular event in the last 6 months
• Stage 4 and above kidney disease
• Active infection, cancer or autoimmune disease
• 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

Sponsors & Collaborators

• Hospital Universitari de Bellvitge: lead
• Institut d'Investigació Biomèdica de Bellvitge: collaborator
• Gilead Sciences: collaborator

Study Sites (1)

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor, Ph.D, Clinical investigator.

Study Record Dates

• First Submitted: July 23, 2025
• First Posted: March 6, 2026
• Study Start: April 23, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)