Division of Gastroenterology and Hepatology, Department of Medicine, The Pennsylvania State University-Milton S. Hershey Medical Center, Hershey, Pennsylvania, USA.
Department of Public Health Sciences, The Pennsylvania State University-Milton S. Hershey Medical Center, Hershey, Pennsylvania, USA.
Hepatol Commun. 2023 Mar 17;7(4). doi: 10.1097/HC9.0000000000000052. eCollection 2023 Apr 1.
Lifestyle intervention remains the foundation of clinical care for patients with NASH; however, most patients are unsuccessful in enacting sustained behavioral change. There remains a clear unmet need to develop lifestyle intervention programs to support weight loss. Mobile health (mHealth) programs offer promise to address this need, yet their efficacy remains unexplored.
We conducted a 16-week randomized controlled clinical trial involving adults with NASH. Patients were randomly assigned (1:1 ratio) to receive Noom Weight (NW), a mHealth lifestyle intervention program, or standard clinical care. The primary end point was a change in body weight. Secondary end points included feasibility (weekly app engagement), acceptability (>50% approached enrolled), and safety. Of 51 patients approached, 40 (78%) were randomly assigned (20 NW and 20 standard clinical care). NW significantly decreased body weight when compared to standard clinical care (-5.5 kg vs. -0.3 kg, p = 0.008; -5.4% vs. -0.4%, p = 0.004). More NW subjects achieved a clinically significant weight loss of ≥5% body weight (45% vs. 15%, p = 0.038). No adverse events occurred, and the majority (70%) of subjects in the NW arm met the feasibility criteria.
This clinical trial demonstrated that NW is not only feasible, acceptable, and safe but also highly efficacious because this mHealth lifestyle intervention program led to significantly greater body weight loss than standard clinical care. Future large-scale studies are required to validate these findings with more representative samples and to determine if mHealth lifestyle intervention programs can lead to sustained, long-term weight loss in patients with NASH.
生活方式干预仍然是 NASH 患者临床治疗的基础；然而，大多数患者无法成功实施持续的行为改变。显然，需要开发生活方式干预计划来支持体重减轻。移动健康 (mHealth) 计划有望满足这一需求，但它们的疗效仍有待探索。
我们进行了一项为期 16 周的随机对照临床试验，涉及 NASH 成年人。患者被随机分配（1:1 比例）接受 Noom Weight（NW），一种 mHealth 生活方式干预计划，或标准临床护理。主要终点是体重变化。次要终点包括可行性（每周应用参与度）、可接受性（超过 50%的人接近招募）和安全性。在 51 名被接触的患者中，有 40 名（78%）被随机分配（20 名 NW 和 20 名标准临床护理）。与标准临床护理相比，NW 显著降低了体重（-5.5kg 与-0.3kg，p=0.008；-5.4%与-0.4%，p=0.004）。更多的 NW 受试者实现了临床显著的体重减轻≥5%（45%与 15%，p=0.038）。没有发生不良事件，NW 组的大多数（70%）受试者符合可行性标准。
这项临床试验表明，NW 不仅可行、可接受且安全，而且非常有效，因为这种 mHealth 生活方式干预计划导致的体重减轻明显大于标准临床护理。需要进行更大规模的研究，以更有代表性的样本验证这些发现，并确定 mHealth 生活方式干预计划是否可以在 NASH 患者中导致持续、长期的体重减轻。
