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
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Digital nutritional program
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.
干预措施: Digital nutritional program (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.
干预措施: Standard care dietary and exercice advice. (Behavioral)
结局指标
主要结局
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.
时间窗: 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.
次要结局
- To compare the percentage of participants who achieve at least a 5% reduction at 12 months(From enrollment to month 12)
- To assess maintenance of body weight 6 months 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.(From enrollment to month 12)
- To compare liver stiffness by vibration-controlled transient elastography at 12 months.(From enrollment to month 12)
- To compare total cholesterol at 6 and 12 months, and 6 months after Digital Nutritional Program discontinuation(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(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(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(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(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(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: 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(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(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(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(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 are assessed at 6 and 12 months)
- To evaluate changes in dietary habits at 6 and 12 months, and 6 months after DNP discontinuation.(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.(From enrollment to month 6, 12 and 6 after Digital Nutritional Program discontinuation)
- To evaluate changes on health-related quality of life at 6 and 12 months, and 6 months after DNP discontinuation.(From enrollment to month 6, 12 and 6 after Digital Nutritional Program discontinuation)
研究者
Maria Saumoy
Medical doctor, Ph.D, Clinical investigator.
Hospital Universitari de Bellvitge