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

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.

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.

To compare body weight between month 12 and month 6 after Digital Nutritional Program discontinuation.

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.

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

Total cholesterol measured in mg/dL

Low-density lipoprotein cholesterol measured in mg/dL

High-density lipoprotein cholesterol measured in mg/dL

Tryglicerides measured in mg/dL

Glucose measured in mg/dL

Insulin measured in pmol/L

Liver enzimes include: alanine transaminase, aspartete transaminase and gamma-glutamyl transferase measured in U/L

The mean of two measures at the narrowest point between the lower costal border and the iliac crest during expiration using a tape measure.

Body composition will be measured using a bioelectrical impedance analyzer. Fat mass in Kg and percentage of total body mass will be recorded.

Skeletal muscle mass will be measured using a bioelectrical impedance analyzer.

Body lean mass will be measured using a bioelectrical impedance analyzer.

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.

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)

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.

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).