Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-30 @ 12:08 AM
Study NCT ID:
NCT07456332
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2026-03-10
First Post:
2025-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief 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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 116}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2028-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-06', 'studyFirstSubmitDate': '2025-07-23', 'studyFirstSubmitQcDate': '2026-03-04', 'lastUpdatePostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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.', 'timeFrame': 'From enrollment to month 6', 'description': 'Percentage of body weight change=( baseline body weight-6 month body weight/baseline body weight)×100.\n\nWe will compare the percentage of participants who achieve a body weight reduction of ≥ 5% between the two arms, at month 6.'}], 'secondaryOutcomes': [{'measure': 'To compare the percentage of participants who achieve at least a 5% reduction at 12 months', 'timeFrame': 'From enrollment to month 12', 'description': 'Percentage of body weight change=( Baseline body weight-6 month body weight/baseline body weight)×100.\n\nWe will compare the percentage of participants who achieve a body weight reduction of ≥ 5% between the two arms, at month 12.'}, {'measure': 'To assess maintenance of body weight 6 months after Digital Nutritional Program discontinuation.', 'timeFrame': 'From month 12 to month 6 after Digital Nutritional Program discontinuation.', 'description': 'To compare body weight between month 12 and month 6 after Digital Nutritional Program discontinuation.'}, {'measure': 'To compare liver steatosis by vibration-controlled transient elastography at 12 months.', 'timeFrame': 'From enrollment to month 12', 'description': '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.'}, {'measure': 'To compare liver stiffness by vibration-controlled transient elastography at 12 months.', 'timeFrame': 'From enrollment to month 12', 'description': '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'}, {'measure': 'To compare total cholesterol at 6 and 12 months, and 6 months after Digital Nutritional Program discontinuation', 'timeFrame': 'From enrollment to month 6, 12 and 6 after Digital Nutritional Program discontinuation.', 'description': 'Total cholesterol measured in mg/dL'}, {'measure': 'To compare low-density lipoprotein cholesterol at 6 and 12 months, and 6 months after Digital Nutritional Program discontinuation', 'timeFrame': 'From enrollment to month 6, 12 and 6 after Digital Nutritional Program discontinuation.', 'description': 'Low-density lipoprotein cholesterol measured in mg/dL'}, {'measure': 'To compare high-density lipoprotein cholesterol at 6 and 12 months, and 6 months after Digital Nutritional Program discontinuation', 'timeFrame': 'From enrollment to month 6, 12 and 6 after Digital Nutritional Program discontinuation.', 'description': 'High-density lipoprotein cholesterol measured in mg/dL'}, {'measure': 'To compare tryglicerides at 6 and 12 months, and 6 months after Digital Nutritional Program discontinuation', 'timeFrame': 'From enrollment to month 6, 12 and 6 after Digital Nutritional Program discontinuation.', 'description': 'Tryglicerides measured in mg/dL'}, {'measure': 'To compare blood glucose at 6 and 12 months, and 6 months after Digital Nutritional Program discontinuation', 'timeFrame': 'From enrollment to month 6, 12 and 6 after Digital Nutritional Program discontinuation.', 'description': 'Glucose measured in mg/dL'}, {'measure': 'To compare plasma insulin at 6 and 12 months, and 6 months after Digital Nutritional Program discontinuation', 'timeFrame': 'From enrollment to month 6, 12 and 6 after Digital Nutritional Program discontinuation.', 'description': 'Insulin measured in pmol/L'}, {'measure': 'To compare plasma liver enzymes at 6 and 12 months, and 6 months after Digital Nutritional Program discontinuation', 'timeFrame': 'Time Frame: From enrollment to month 6, 12 and 6 after Digital Nutritional Program discontinuation.', 'description': 'Liver enzimes include: alanine transaminase, aspartete transaminase and gamma-glutamyl transferase measured in U/L'}, {'measure': 'To compare waist circunference at 6 and 12 months, and 6 months after DNP discontinuation', 'timeFrame': 'From enrollment to month 6, 12 and 6 after Digital Nutritional Program discontinuation.', 'description': 'The mean of two measures at the narrowest point between the lower costal border and the iliac crest during expiration using a tape measure.'}, {'measure': 'To compare body fat mass using a bioelectrical impedance analyzer at 6 and 12 months, and 6 months after DNP discontinuation', 'timeFrame': 'From enrollment to month 6, 12 and 6 after Digital Nutritional Program discontinuation.', 'description': 'Body composition will be measured using a bioelectrical impedance analyzer. Fat mass in Kg and percentage of total body mass will be recorded.'}, {'measure': 'To compare skeletal muscle mass using a bioelectrical impedance analyzer at 6 and 12 months, and 6 months after DNP discontinuation', 'timeFrame': 'From enrollment to month 6, 12 and 6 after Digital Nutritional Program discontinuation.', 'description': 'Skeletal muscle mass will be measured using a bioelectrical impedance analyzer.'}, {'measure': 'To compare body lean mass using a bioelectrical impedance analyzer at 6 and 12 months, and 6 months after DNP discontinuation', 'timeFrame': 'From enrollment to month 6, 12 and 6 after Digital Nutritional Program discontinuation.', 'description': 'Body lean mass will be measured using a bioelectrical impedance analyzer.'}, {'measure': 'To evaluate changes in dietary habits at 6 and 12 months, and 6 months after DNP discontinuation.', 'timeFrame': 'From enrollment to month 6, 12 and 6 after Digital Nutritional Program discontinuation.', 'description': '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.'}, {'measure': 'To evaluate changes physical actvity at 6 and 12 months, and 6 months after DNP discontinuation.', 'timeFrame': 'From enrollment to month 6, 12 and 6 after Digital Nutritional Program discontinuation', 'description': '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.\n\nThe questionnaire assesses three intensity levels of activity:\n\n* Vigorous-intensity activities (e.g., running, aerobic exercise, competitive sports)\n* Moderate-intensity activities (e.g., carrying light loads, cycling at a regular pace, recreational swimming)\n* Walking Data Collected for each activity: Number of days per week they performed the activity, average time per day.\n\nUnit: Metabolic Equivalent Task minutes per week (MET-minutes/week):\n\n* Walking: 3.3 METs\n* Moderate activity: 4.0 METs\n* 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)'}, {'measure': 'To evaluate digital nutritional program adherence at 6 and 12 months.', 'timeFrame': 'Data are assessed at 6 and 12 months', 'description': "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."}, {'measure': 'To evaluate changes on health-related quality of life at 6 and 12 months, and 6 months after DNP discontinuation.', 'timeFrame': 'From enrollment to month 6, 12 and 6 after Digital Nutritional Program discontinuation', 'description': '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).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Metabolic dysfunction-associated steatotic liver disease', 'People living with HIV', 'Digital nutritional program', 'life style'], 'conditions': ['Metabolic Dysfunction-Associated Steatotic Liver Disease', 'People Living With HIV', 'Life Style']}, 'descriptionModule': {'briefSummary': "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.\n\nThis 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.\n\nThe study includes people living with HIV, aged 18 and older, with fatty liver (detected by ultrasound or other scans), and on stable HIV treatment.\n\nParticipants will be randomly assigned to two groups:\n\n* Intervention group: Will receive personalized lifestyle support through a mobile app (DNP).\n* Control group: Will receive general advice on healthy habits. The study will last 12 months, with follow-up visits during and after the program.\n\nWhat Will Be Measured:\n\n* Weight, waist size, blood pressure, and body fat.\n* Blood tests to check cholesterol, sugar levels, liver enzymes, and other markers.\n* Liver scans to assess fat and stiffness.\n* Questionnaires on eating habits, exercise, and satisfaction with the program.\n\nGoals of the Study:\n\nMain goal: To see how many people lose at least 5% of their body weight after 6 months.\n\nOther goals: To see the effects on weight after 12 months, and 6 months after stopping the program, and to monitor improvements in liver health.\n\nWhy This Matters:\n\nThis 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* HIV-infected patients\n* ≥ 18 years of age\n* On stable antiretroviral therapy during the last 6 months\n* HIV viral load \\<50 copies/ml for ≥ 6 months\n* CD4 cell count \\>200 cells/uL\n* Diagnosis of liver steatosis on ultrasound or Controlled Attenuation Parameter (CAP) measured by vibration-controlled transient elastography\n\nExclusion Criteria:\n\n* Body mass index ≤ 23 kg/m2\n* Presence of a condition that precluded modification of activity or diet behaviour\n* Known liver disease other tan MASLD including viral, haemochromatosis, Wilson's Disease, alpha-1 antitripsin deficiency, autoimmune hepatitis and cirrhosis\n* Excessive alcohol consumption (\\>15 gr/day for women and 30 gr/day for men),\n* Endocrine disorders: hyperthyroidism or uncontrolled hypothyroidism\n* Pharmacological treatment with immunosuppressants, cytotoxic agents, systemic corticosteroids, or other drugs that could potentially cause hepatic steatosis (amiodarone, tamoxifen, methotrexate) or alter liver tests\n* The use of weight modifiers or previous weight loss surgery at any time\n* Cardiovascular event in the last 6 months\n* Stage 4 and above kidney disease\n* Active infection, cancer or autoimmune disease\n* Inability to use an internet application or not having a Smartphone,\n* Low command of spanish or illiteracy,\n* Refusal to give informed consent\n* Pregnant women or women planning pregnancy"}, 'identificationModule': {'nctId': 'NCT07456332', 'acronym': 'APEVI', 'briefTitle': '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', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitari de Bellvitge'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'PR002/25'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Digital nutritional program', 'description': "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.", 'interventionNames': ['Behavioral: Digital nutritional program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard care dietary and exercice advice', 'description': '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.', 'interventionNames': ['Behavioral: Standard care dietary and exercice advice.']}], 'interventions': [{'name': 'Digital nutritional program', 'type': 'BEHAVIORAL', 'description': "* 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.\n* 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.", 'armGroupLabels': ['Digital nutritional program']}, {'name': 'Standard care dietary and exercice advice.', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Standard care dietary and exercice advice']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08907', 'city': "L'Hospitalet de Llobregat", 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Universitari de Bellvitge', 'geoPoint': {'lat': 41.35967, 'lon': 2.10028}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitari de Bellvitge', 'class': 'OTHER'}, 'collaborators': [{'name': "Institut d'Investigació Biomèdica de Bellvitge", 'class': 'OTHER'}, {'name': 'Gilead Sciences', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical doctor, Ph.D, Clinical investigator.', 'investigatorFullName': 'Maria Saumoy', 'investigatorAffiliation': 'Hospital Universitari de Bellvitge'}}}}