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 (APEVI)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Life Style; People Living With HIV; Metabolic Dysfunction-Associated Steatotic Liver Disease
• Intervention / Treatment: Behavioral: Digital nutritional program; Behavioral: Standard care dietary and exercice advice.

• Study Type: Interventional
• Enrollment (Estimated): 116
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Hospital Universitari de Bellvitge

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Digital nutritional program; 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; 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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
To compare the percentage of participants who achieve at least a 5% reduction at 12 months	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 12.	From enrollment to month 12
To assess maintenance of body weight 6 months after Digital Nutritional Program discontinuation.	To compare body weight between month 12 and month 6 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.	Liver steatosis will be assessed using the Controlled Attenuation Parameter obtained by transient elastography, with a cutoff value of 275 dB/m used to define liver steatosis.	From enrollment to month 12
To compare liver stiffness by vibration-controlled transient elastography at 12 months.	Liver stiffness will be assessed by transient elastography, with a cutoff value of 8-12 kPa may be associated with fibrosis and > 12 kPa is associated with a high likelihood of advanced fibrosis	From enrollment to month 12
To compare total cholesterol at 6 and 12 months, and 6 months after Digital Nutritional Program discontinuation	Total cholesterol measured in mg/dL	From enrollment to month 6, 12 and 6 after Digital Nutritional Program discontinuation.
To compare low-density lipoprotein cholesterol at 6 and 12 months, and 6 months after Digital Nutritional Program discontinuation	Low-density lipoprotein cholesterol measured in mg/dL	From enrollment to month 6, 12 and 6 after Digital Nutritional Program discontinuation.
To compare high-density lipoprotein cholesterol at 6 and 12 months, and 6 months after Digital Nutritional Program discontinuation	High-density lipoprotein cholesterol measured in mg/dL	From enrollment to month 6, 12 and 6 after Digital Nutritional Program discontinuation.
To compare tryglicerides at 6 and 12 months, and 6 months after Digital Nutritional Program discontinuation	Tryglicerides measured in mg/dL	From enrollment to month 6, 12 and 6 after Digital Nutritional Program discontinuation.
To compare blood glucose at 6 and 12 months, and 6 months after Digital Nutritional Program discontinuation	Glucose measured in mg/dL	From enrollment to month 6, 12 and 6 after Digital Nutritional Program discontinuation.
To compare plasma insulin at 6 and 12 months, and 6 months after Digital Nutritional Program discontinuation	Insulin measured in pmol/L	From enrollment to month 6, 12 and 6 after Digital Nutritional Program discontinuation.
To compare plasma liver enzymes at 6 and 12 months, and 6 months after Digital Nutritional Program discontinuation	Liver enzimes include: alanine transaminase, aspartete transaminase and gamma-glutamyl transferase measured in U/L	Time Frame: From enrollment to month 6, 12 and 6 after Digital Nutritional Program discontinuation.
To compare waist circunference at 6 and 12 months, and 6 months after DNP discontinuation	The mean of two measures at the narrowest point between the lower costal border and the iliac crest during expiration using a tape measure.	From enrollment to month 6, 12 and 6 after Digital Nutritional Program discontinuation.
To compare body fat mass using a bioelectrical impedance analyzer at 6 and 12 months, and 6 months after DNP discontinuation	Body composition will be measured using a bioelectrical impedance analyzer. Fat mass in Kg and percentage of total body mass will be recorded.	From enrollment to month 6, 12 and 6 after Digital Nutritional Program discontinuation.
To compare skeletal muscle mass using a bioelectrical impedance analyzer at 6 and 12 months, and 6 months after DNP discontinuation	Skeletal muscle mass will be measured using a bioelectrical impedance analyzer.	From enrollment to month 6, 12 and 6 after Digital Nutritional Program discontinuation.
To compare body lean mass using a bioelectrical impedance analyzer at 6 and 12 months, and 6 months after DNP discontinuation	Body lean mass will be measured using a bioelectrical impedance analyzer.	From enrollment to month 6, 12 and 6 after Digital Nutritional Program discontinuation.
To evaluate digital nutritional program adherence at 6 and 12 months.	Data to evaluate adherence will by recorded by the digital program based on the participant's usage. A patient is considered adherent if he has been accessing the program for a minimum period of 30 calendar days in 6 months.	Data are assessed at 6 and 12 months
To evaluate changes in dietary habits at 6 and 12 months, and 6 months after DNP discontinuation.	To assess dietary habits Mediterranean Diet Adherence Questionnaire will be used. The questionnaire includes key dietary components (fruits, vegetables, legumes, fish, olive oil, meats, beverages). Each item is scored according to the scale criteria. Minimum value 0, maximum value 14. Higher scores indicate greater adherence. A score above 10 indicates good adherence to the Mediterranean diet. A score <7 indicates low adherence.	From enrollment to month 6, 12 and 6 after Digital Nutritional Program discontinuation.
To evaluate changes physical actvity at 6 and 12 months, and 6 months after DNP discontinuation.	To assess physical activity we use Physical Activity Questionnaire-Short Form. The IPAQ-SF is a 7-item questionnaire designed to estimate the frequency and duration of physical activity performed during the previous 7 days. The questionnaire assesses three intensity levels of activity: Vigorous-intensity activities (e.g., running, aerobic exercise, competitive sports); Moderate-intensity activities (e.g., carrying light loads, cycling at a regular pace, recreational swimming); Walking Data Collected for each activity: Number of days per week they performed the activity, average time per day. Unit: Metabolic Equivalent Task minutes per week (MET-minutes/week): Walking: 3.3 METs; Moderate activity: 4.0 METs; Vigorous activity: 8.0 METs The total physical activity score :MET value×minutes per day×days per weeK Participants are classified in 3 cathegories:ow (<600 MET-min/week), moderate (600-2999 MET-min/week), and high (≥3000 MET-min/week)	From enrollment to month 6, 12 and 6 after Digital Nutritional Program discontinuation
To evaluate changes on health-related quality of life at 6 and 12 months, and 6 months after DNP discontinuation.	To assess health-related quality of life we use the Euro quality of life 5 dimensions (EuroQoL-5D) health questionnaire. This self-reported instrument evaluates mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Three dimension level is used. Responses across the five dimensions were converted into a utility index using population value sets, ranging from values below 0 (health states worse than death) to 1 (perfect health).	From enrollment to month 6, 12 and 6 after Digital Nutritional Program discontinuation

Collaborators and Investigators

• Sponsor: Hospital Universitari de Bellvitge
• Collaborators: Gilead Sciences; Institut d'Investigació Biomèdica de Bellvitge

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: July 23, 2025
• First Submitted That Met QC Criteria: March 4, 2026
• First Posted (Actual): March 6, 2026

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 6, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: life style; People living with HIV; Metabolic dysfunction-associated steatotic liver disease; Digital nutritional program
• Other Study ID Numbers: PR002/25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No