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

Обзор

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.

Вмешательства

• Поведенческое 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
• Поведенческое 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.

Первичные конечные точки

• 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. [Срок оценки: From enrollment to month 6]

Вторичные конечные точки (12)

• To compare the percentage of participants who achieve at least a 5% reduction at 12 months [Срок оценки: From enrollment to month 12]
• To assess maintenance of body weight 6 months after Digital Nutritional Program discontinuation. [Срок оценки: From month 12 to month 6 after Digital Nutritional Program discontinuation.]
• To compare liver steatosis by vibration-controlled transient elastography at 12 months. [Срок оценки: From enrollment to month 12]
• To compare liver stiffness by vibration-controlled transient elastography at 12 months. [Срок оценки: From enrollment to month 12]
• To compare total cholesterol at 6 and 12 months, and 6 months after Digital Nutritional Program discontinuation [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: From enrollment to month 6, 12 and 6 after Digital Nutritional Program discontinuation.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Hospital Universitari de Bellvitge — L'Hospitalet de Llobregat

Идентификаторы

NCT: NCT07456332 · PR002/25

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗