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

Oscar Castro, Future Health Technologies, Singapore-ETH Centre, Campus for Research Excellence and Technological Enterprise (CREATE), Singapore. Electronic address: oscar.castro@sec.ethz.ch.
Jacqueline Louise Mair, Future Health Technologies, Singapore-ETH Centre, Campus for Research Excellence and Technological Enterprise (CREATE), Singapore; Saw Swee Hock School of Public Health, National University of Singapore, Singapore.
Shenglin Zheng, Future Health Technologies, Singapore-ETH Centre, Campus for Research Excellence and Technological Enterprise (CREATE), Singapore; Saw Swee Hock School of Public Health, National University of Singapore, Singapore.
Sarah Yi Tan, Future Health Technologies, Singapore-ETH Centre, Campus for Research Excellence and Technological Enterprise (CREATE), Singapore; Saw Swee Hock School of Public Health, National University of Singapore, Singapore.
Ahmad Ishqi Jabir, Future Health Technologies, Singapore-ETH Centre, Campus for Research Excellence and Technological Enterprise (CREATE), Singapore.
Xiaoxi Yan, Centre for Quantitative Medicine, Duke-NUS Medical School, Singapore.
Bibhas Chakraborty, Centre for Quantitative Medicine, Duke-NUS Medical School, Singapore; Department of Statistics and Data Science, National University of Singapore, Singapore; Department of Biostatistics and Bioinformatics, Duke University, Durham, NC, USA.
E Shyong Tai, Future Health Technologies, Singapore-ETH Centre, Campus for Research Excellence and Technological Enterprise (CREATE), Singapore; Saw Swee Hock School of Public Health, National University of Singapore, Singapore; Yong Loo Lin School of Medicine, National University of Singapore, Singapore.
Rob M. van Dam, Saw Swee Hock School of Public Health, National University of Singapore, Singapore; Department of Exercise and Nutrition Sciences, Milken Institute School of Public Health, George Washington University, Washington, DC, USA.
Florian von Wangenheim, Future Health Technologies, Singapore-ETH Centre, Campus for Research Excellence and Technological Enterprise (CREATE), Singapore; Centre for Digital Health Interventions, Department of Management, Technology, and Economics, ETH Zurich, Zurich, Switzerland.
Elgar Fleisch, Future Health Technologies, Singapore-ETH Centre, Campus for Research Excellence and Technological Enterprise (CREATE), Singapore; Centre for Digital Health Interventions, Department of Management, Technology, and Economics, ETH Zurich, Zurich, Switzerland; Centre for Digital Health Interventions, Institute of Technology Management, University of St. Gallen, St. Gallen, Switzerland.
Konstadina Griva, Office of Research, Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore.
Tobias Kowatsch, Future Health Technologies, Singapore-ETH Centre, Campus for Research Excellence and Technological Enterprise (CREATE), Singapore; Centre for Digital Health Interventions, Department of Management, Technology, and Economics, ETH Zurich, Zurich, Switzerland; Centre for Digital Health Interventions, Institute for Implementation Science in Health Care, University of Zurich, Zurich, Switzerland; Centre for Digital Health Interventions, School of Medicine, University of St. Gallen, St. Gallen, Switzerland.
Falk Müller-Riemenschneider, Saw Swee Hock School of Public Health, National University of Singapore, Singapore; Digital Health Center, Berlin Institute of Health, Charité-Universitätsmedizin Berlin, Berlin, Germany.

Document Type

Journal Article

Publication Date

3-1-2025

Journal

Contemporary clinical trials

Volume

150

DOI

10.1016/j.cct.2025.107833

Keywords

Depression; Diabetes; Digital health; Health behaviour change; Implementation science; Mental health; Stepped care

Abstract

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).

Department

Exercise and Nutrition Sciences

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