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| Name | Class |
|---|---|
| Institut d'Investigació Biomèdica de Bellvitge | OTHER |
| Gilead Sciences | INDUSTRY |
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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:
What Will Be Measured:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital nutritional program | Behavioral |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari de Bellvitge | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
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| 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. |
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| 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 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:
Unit: Metabolic Equivalent Task minutes per week (MET-minutes/week):
| 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 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 |