Effectiveness of a Smartphone App in Promoting Weight Loss in Patients With Non-alcoholic Fatty Liver Disease: a Pilot Multi-centre Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 260
- 试验地点
- 2
- 主要终点
- Change in body weight
研究概览
简要总结
Non-alcoholic fatty liver disease (NAFLD) is a disease spectrum that encompasses excessive liver deposition of fat (NAFL), non-alcoholic steatohepatitis (NASH), and NASH cirrhosis. NAFLD is regarded as the hepatic manifestation of metabolic syndrome and is currently the most common etiology for chronic liver disease worldwide, affecting 25% of the adult population globally. It is estimated that cirrhosis and liver-related death occur in 20% and 12%, respectively, over a 10-year period in patients with NAFLD. The incidence of decompensated cirrhosis and hepatocellular carcinoma (HCC) due to NAFLD are increasing with time. In United States, the number of patient listing for liver transplantation (LT) due to NAFLD has surpassed that of from chronic viral hepatitis and is currently the second leading cause for LT waitlist overall. Locally, the prevalence of NAFLD is estimated to be 42% according to a health census in healthy blood donors in Hong Kong, and up to 13.5% healthy subjects will develop new onset NAFLD in 3-5 years of follow-up.
Clearly, NAFLD is a chronic liver disease with alarmingly high prevalence that warrants attention. Despite the high prevalence and potential to develop serious liver-related morbidity, there are currently no approved drugs for patients with NAFLD. To achieve resolution of steatohepatitis and improvement of liver fibrosis, weight loss appears to be the only effective means.
This study is aimed to evaluate the effectiveness of a self-developed smartphone app for achieving weight loss in Chinese adults with non-alcoholic fatty-liver disease (NAFLD) at 12 months. Endorsed by the WHO, mobile technology is being increasingly used to promote health. There is a lack of research on the use of mobile technology for promoting weight loss in Chinese NAFLD patients.
详细描述
The Investigators formed a multi-disciplinary team consisting of hepatologist, computer scientist, dietitian and endocrinologist. The investigators hypothesize that NAFLD subjects who use the dedicated smartphone app will achieve more weight loss than subjects who are managed with standard of care (SOC) without smartphone app.
The present study is a multi-center, two-arm randomized, placebo-controlled, 1:1 trial to examine the effectiveness of a self-developed simple-to-use smartphone app for NAFLD patients. The smartphone app consists of elements that track health data, provide health education, estimate calorie intake and energy expenditure. Anthropometric measurements, blood tests, transient elastography, and bioelectrical impedance analysis will be performed at baseline and 12 months. The intervention is either Smartphone app vs SOC. The main outcome measures will include changes in body weight, liver fat, liver enzyme, muscle mass, lipid and glucose profile.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •known NAFLD
- •able to read and understand Chinese
- •owns a compatible smartphone
- •without major cognitive impairment.
排除标准
- •newly initiated on sodium-glucose cotransporter 2 inhibitors, glucagon-like peptide 1 receptor agonists or thiazolidinediones or had recent dose adjustments (within 3 months)
- •patients with cirrhosis
- •patients who are pregnant
- •patients on special diet or with special dietary requirement (e.g. vegan, gluten free)
- •patients with heavy alcohol use (≥20 grams/ day for women or ≥30 grams/ day for men)
- •history of HCC or LT
研究组 & 干预措施
Smartphone app arm
Use the dedicated smartphone app for NAFLD patients
干预措施: Smartphone app use (Behavioral)
Standard of care
Standard of care
干预措施: Standard of care (Behavioral)
结局指标
主要结局
Change in body weight
时间窗: 12 months
Body weight of the participants will be measured at baseline and 12 months
次要结局
- Changes in lipid profile(12 months)
- Reduction in hepatic steatosis(12 months)
- ALT normalization(12 months)
- Changes in glucose levels(12 months)
- Reversal of sarcopenia(12 months)
- Visceral fat reduction(12 months)