LvL UP试验：一项连续、多任务、随机对照试验的方案，以评估混合移动生活方式干预的有效性。

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2025-02-01 DOI:10.1016/j.cct.2025.107833

Oscar Castro , Jacqueline Louise Mair , Shenglin Zheng , Sarah Yi Xuan Tan , Ahmad Ishqi Jabir , Xiaoxi Yan , Bibhas Chakraborty , E Shyong Tai , Rob M. van Dam , Florian von Wangenheim , Elgar Fleisch , Konstadina Griva , Tobias Kowatsch , Falk Müller-Riemenschneider

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引用次数: 0

摘要

背景：混合移动保健（mHealth）干预措施——结合自我指导和人力支持组成部分——可在预防非传染性疾病（NCDs）和常见精神障碍（cmd）方面发挥重要作用。本方案描述了一项顺序、多任务、随机试验，旨在(i)评估LvL UP的有效性和成本效益，LvL UP是一种预防非传染性疾病和慢性疾病的移动健康生活方式干预，以及（ii）在LvL UP中建立最佳混合方法，平衡有效的个性化生活方式支持和可扩展性。方法：LvL UP是一项为期6个月的移动健康整体干预，目标是身体活动、饮食和情绪调节。在这项试验中，有非传染性疾病或慢性阻塞性肺病风险的年轻和中年新加坡成年人将被随机分配到两种初始条件之一（“LvL UP”或“比较”）。4 周后，从LvL UP组中被分类为无反应的参与者将被重新随机分配到第二阶段条件：(i)继续进行初始干预（LvL UP）或（ii）由训练有素的健康教练进行额外的动机性访谈（MI）支持课程（LvL UP +适应性MI）。最主要的结果是心理健康。次要结局包括人体测量、静息血压、血液代谢谱、健康状况和健康行为（身体活动、饮食）。结果将在基线、6 个月（干预后）和12 个月（随访）时进行测量。讨论：除了评估LvL UP的有效性之外，拟议的研究设计将有助于增加关于如何在移动医疗干预中引入人类支持以最大化其有效性同时保持可扩展性的证据。试验注册：LvL UP试点试验已在ClinicalTrials.gov （NCT06360029）前瞻性注册。

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The LvL UP trial: Protocol for a sequential, multiple assignment, randomised controlled trial to assess the effectiveness of a blended mobile lifestyle intervention

Background

Blended mobile health (mHealth) interventions – combining self-guided and human support components – could play a major role in preventing non-communicable diseases (NCDs) and common mental disorders (CMDs). This protocol describes a sequential, multiple assignment, randomised trial aimed at (i) evaluating the effectiveness and cost-effectiveness of LvL UP, an mHealth lifestyle intervention for the prevention of NCDs and CMDs, and (ii) establishing the optimal blended approach in LvL UP that balances effective personalised lifestyle support with scalability.

Methods

LvL UP is a 6-month mHealth holistic intervention targeting physical activity, diet, and emotional regulation. In this trial, young and middle-aged Singaporean adults at risk of developing NCDs or CMDs will be randomly allocated to one of two initial conditions (‘LvL UP’ or ‘comparison’). After 4 weeks, participants categorised as non-responders from the LvL UP group will be re-randomised into second-stage conditions: (i) continuing with the initial intervention (LvL UP) or (ii) additional motivational interviewing (MI) support sessions by trained health coaches (LvL UP + adaptive MI). The primary outcome is mental well-being. Secondary outcomes include anthropometric measurements, resting blood pressure, blood metabolic profile, health status, and health behaviours (physical activity, diet). Outcomes will be measured at baseline, 6 months (post-intervention), and 12 months (follow-up).

Discussion

In addition to evaluating the effectiveness of LvL UP, the proposed study design will contribute to increasing evidence on how to introduce human support in mHealth interventions to maximise their effectiveness while remaining scalable.

Trial registration

The LvL UP Pilot trial was prospectively registered with ClinicalTrials.gov (NCT06360029).

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.