Metabolic Dysfunction-Associated Steatotic Liver DiseaseAPEVINCT07456332
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
A study testing Digital nutritional program in people with Metabolic Dysfunction-Associated Steatotic Liver Disease and People Living With HIV, run by Hospital Universitari de Bellvitge at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolic Dysfunction-Associated Steatotic Liver Disease, People Living With HIV, Life Style
- What is being tested?
- Digital nutritional program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteSpain
- Study dates
- 23 Apr 2025to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
About this study
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.
Read more
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
- Being tested
- Digital nutritional program, Standard care dietary and exercice advice.
- Keywords
- Metabolic dysfunction-associated steatotic liver disease, People living with HIV, Digital nutritional program, life style
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital nutritional programBehavioural
- 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.
Standard care dietary and exercice advice.Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Standard care dietary and exercice advice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to month 6
Secondary outcomes (19)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to month 6, 12 and 6 after Digital Nutritional Program discontinuation.
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.
Measured: 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)
Measured: 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.
Measured: Data are assessed at 6 and 12 months
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).
Measured: From enrollment to month 6, 12 and 6 after Digital Nutritional Program discontinuation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start23 Apr 2025
- Primary completionAug 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Dysfunction-Associated Steatotic Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari de Bellvitge
- Sponsor type
- University, hospital or other
- Collaborators
- Institut d'Investigació Biomèdica de Bellvitge, Gilead Sciences
- Responsible party
- Principal investigator, Maria Saumoy, Hospital Universitari de Bellvitge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07456332
- Sponsor's protocol ID
- PR002/25
- Acronym
- APEVI
- Status last verified
- Mar 2026
- First submitted
- 23 Jul 2025
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07456332
- Acronym / sponsor ID
- APEVI / PR002/25
- Conditions
- Metabolic Dysfunction-Associated Steatotic Liver Disease, People Living With HIV, Life Style
- Keywords
- Metabolic dysfunction-associated steatotic liver disease, People living with HIV, Digital nutritional program, life style
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Hospital Universitari de BellvitgeUniversity, hospital or other
- Collaborators
- Institut d'Investigació Biomèdica de Bellvitge, Gilead Sciences
- Study start
- 23 Apr 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 6 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital nutritional program | Experimental | Behavioral: Digital nutritional programDigital 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. |
| Standard care dietary and exercice advice | Active comparator | 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Digital nutritional program |
| 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. | Behavioural | Standard care dietary and exercice advice |
Primary outcome
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.
Time frame: From enrollment to 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 6.
19 secondary outcomes
To compare the percentage of participants who achieve at least a 5% reduction at 12 months
Time frame: From enrollment to month 12
To assess maintenance of body weight 6 months after Digital Nutritional Program discontinuation.
Time frame: From month 12 to month 6 after Digital Nutritional Program discontinuation.
To compare liver steatosis by vibration-controlled transient elastography at 12 months.
Time frame: From enrollment to month 12
To compare liver stiffness by vibration-controlled transient elastography at 12 months.
Time frame: From enrollment to month 12
To compare total cholesterol at 6 and 12 months, and 6 months after Digital Nutritional Program discontinuation
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From enrollment to month 6, 12 and 6 after Digital Nutritional Program discontinuation.
To evaluate changes in dietary habits at 6 and 12 months, and 6 months after DNP discontinuation.
Time frame: 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.
Time frame: From enrollment to month 6, 12 and 6 after Digital Nutritional Program discontinuation
To evaluate digital nutritional program adherence at 6 and 12 months.
Time frame: Data are assessed at 6 and 12 months
To evaluate changes on health-related quality of life at 6 and 12 months, and 6 months after DNP discontinuation.
Time frame: From enrollment to month 6, 12 and 6 after Digital Nutritional Program discontinuation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital nutritional program in people with Metabolic Dysfunction-Associated Steatotic Liver Disease and People Living With HIV, run by Hospital Universitari de Bellvitge at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: From enrollment to month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.