The LvL UP Pilot Trial

NCT06360029 | Completed

• 1 other identifier: LvL UP
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 2

Brief Summary

Non-communicable diseases (NCDs), such as cardiovascular disease, diabetes, or cancer, and common mental disorders (CMDs), such as depression or anxiety, represent the primary causes of death and disability worldwide, causing major health and financial burdens. Lifestyle behaviours, including physical activity, diet, stress and emotional regulation, tobacco smoking, alcohol consumption, and sleep are important modifiable risk factors associated with the prevention and management of both NCDs and CMDs. LvL UP is a mHealth intervention aimed at preventing NCDs and CMDs in adults from multi-ethnic Southeast Asian populations (Castro et al., 2023). Building upon leading evidence- and theory-based frameworks in the areas of mental health and behaviour change, a multidisciplinary team of researchers developed LvL UP as a holistic intervention centred around three core pillars: Move More, Eat Well, Stress Less. The goal of this pilot study is to assess the feasibility of a Sequential, Multiple Assignment, Randomized Trial (SMART) aimed at (i) evaluating the effectiveness and cost-effectiveness of LvL UP and (ii) establishing the optimal blended approach in LvL UP that balances effective personalized lifestyle support with scalability. The main questions it aims to answer are:

1. 1.What are the intervention's preliminary, short-term effects? What is the intervention's level of engagement? What is the number of dropouts? What is the percentage of missing data? What is the intervention's responder / non-responder rate after week 4? How easy was to recruit the target sample size and which channels worked best?
2. 2.Considering the above pilot study results: What is the overall feasibility of the SMART research protocol in its current form? Are there any changes required for the main trial? This includes: recruitment approach, intervention content and delivery (app, provision of human support), and/or trial assessments (online and in-person).

Conditions

Health Behavior; Noncommunicable Diseases; Mental Health Issue; Lifestyle Risk Reduction

Keywords

Prevention; Healthy lifestyle; Physical activity; Diet; Mental well-being; Digital health interventions; Mobile Health

Outcome Measures

Primary Outcomes (1)

• Mental well-being (Warwick-Edinburgh Mental Well-being Scale)

  Assessed using the Warwick-Edinburgh Mental Well-being Scale (WEMWBS-14). The total score ranges from 14 to 70, with higher values indicating higher mental well-being.

  Baseline, week 4, week 8

Secondary Outcomes (17)

• Subjective well-being (World Health Organization Well-Being Index)

  Baseline, week 4, week 8

• Mental health (depression - Patient Health Questionnaire-9)

  Baseline, week 4, week 8

• Mental health (stress - Kessler Psychological Distress Scale)

  Baseline, week 4, week 8

• Health-related quality of life (European Quality of Life 5 Dimensions 5 Level Version)

  Baseline, week 8

• Health behaviours (physical activity - International Physical Activity Questionnaire)

  Baseline, week 4, week 8

Other Outcomes (38)

• LvL UP app: Response time to app notifications

  Continuously throughout the study period (i.e., assessed every day during 8 weeks)

• LvL UP app: Duration of app usage in minutes

  Continuously throughout the study period (i.e., assessed every day during 8 weeks)

• LvL UP app: Actual usage of app components (number of times used and duration)

  Continuously throughout the study period (i.e., assessed every day during 8 weeks)

Study Arms (3)

LvL UP

EXPERIMENTAL

Downloading and using the LvL UP app

Behavioral: LvL UP

LvL UP + MI

EXPERIMENTAL

Downloading and using the LvL UP app + taking part in motivational interviewing support sessions

Behavioral: LvL UP + MI

Comparison

ACTIVE COMPARATOR

Receiving healthy lifestyle and mental well-being resources from Singapore's Health Promotion Board

Behavioral: Comparison

Interventions

LvL UP BEHAVIORAL

The LvL UP app includes four lifestyle intervention components centred around three core pillars, Move More (physical activity), Eat Well (healthy nutrition), and Stress Less (mental well-being), as follows: (i) conversational agent-delivered health literacy coaching sessions, (ii) daily "Life Hacks" (healthy habit suggestions), (iii) therapeutic Tools including step-based activity tracker, food diary, and journal and (iv) gamified slow-paced breathing training (Breeze). These components are delivered using an innovative engagement approach that combines storytelling, MI, feedback on progress, just-in-time adaptive notifications and gamification. As part of the LvL UP app onboarding, participants are asked to nominate a 'LvL UP Buddy' (e.g., a friend, family member, or spouse) to provide additional support. Buddies are expected to complete different tasks, such as sending messages of encouragement or engaging in intervention-related activities together with the participant.

LvL UP

LvL UP + MI BEHAVIORAL

After 4 weeks, participants categorized as non-responders from the LvL UP group will be re-randomized into second-stage conditions: (i) continuing with the initial intervention (LvL UP) or (ii) additional human-delivered motivational interviewing (MI) support sessions (LvL UP + MI). The MI-informed sessions for non-responders will consist of four sessions delivered via WhatsApp, lasting between 30 and 40 minutes. The content of support will include various MI-based strategies such as use of ask-offer-ask framework and strategic use of communication skills (open-ended questions, reflections, affirmations and summaries) as per four MI processes: * Engaging (foster collaboration and trust the research staff-user relationship) * Focusing (conversation to focus on lifestyle changes) * Evoking (elicit and strengthen participants' motivation towards lifestyle changes), and * Planning (when the participant is ready, commitment to a change plan aimed at adopting a healthy lifestyle).

LvL UP + MI

Comparison BEHAVIORAL

Participants randomised to the comparison condition will receive a study pack including physical activity, diet and mental well-being content extracted from existing Health Promotion Board (HPB) resources. Established in 2001, the HPB (https://hpb.gov.sg/) is a government organisation under the Ministry of Health committed to promoting healthy living in Singapore. HPB's organises health promotion and disease prevention programmes covering various health domains. HPB-developed resources were selected as the comparator because they are the 'go-to', nation-wide health resources in Singapore which cover LvL UP's domains.

Comparison

Eligibility Criteria

• Age: 21 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Aged 21 to 59 years,
• Singapore citizens or permanent residents,
• Planning to reside in Singapore for the duration of the study,
• Proficient in English (the LvL UP app is currently only available in English),
• Owners of a smartphone (minimum requirements: iOS version 12.4 and Android version 8) with internet access,
• Able to provide informed consent, and
• Identified as 'at risk' of developing NCDs and/or CMDs. To identify those 'at risk' of developing NCDs or CMDs, an eligibility survey will assess five different risk factors (physical inactivity, unhealthy diet, poor mental well-being, family history of health conditions, and being overweight or obese) and generate a composite risk factor score.

You may not qualify if:

• Diagnosed with one of the following chronic disease: heart disease (e.g., heart attack and stroke), cancer, chronic respiratory diseases (e.g., chronic obstructed pulmonary disease and asthma), diabetes (type1 and type2), or chronic kidney disease,
• Diagnosed with one of the following mental disorder: major depressive disorders (depression), bipolar, eating disorders, post-traumatic stress disorder, anxiety disorders, severe personality disorder, substance use disorders, or other mental health conditions diagnosed by a mental health professional,
• Pregnant,
• Currently taking medications prescribed for high blood pressure or high blood glucose, and
• Already participating in the study as a LvL UP Buddy.

Sponsors & Collaborators

• Singapore ETH Centre: lead
• ETH Zurich: collaborator
• National University of Singapore: collaborator
• Nanyang Technological University: collaborator

Study Sites (2)

Saw Swee Hock School of Public Health

Singapore, 117549, Singapore

Location

Singapore ETH Center

Singapore, 138602, Singapore

Location

Related Publications (6)

• Castro O, Mair JL, Salamanca-Sanabria A, Alattas A, Keller R, Zheng S, Jabir A, Lin X, Frese BF, Lim CS, Santhanam P, van Dam RM, Car J, Lee J, Tai ES, Fleisch E, von Wangenheim F, Tudor Car L, Muller-Riemenschneider F, Kowatsch T. Development of "LvL UP 1.0": a smartphone-based, conversational agent-delivered holistic lifestyle intervention for the prevention of non-communicable diseases and common mental disorders. Front Digit Health. 2023 May 10;5:1039171. doi: 10.3389/fdgth.2023.1039171. eCollection 2023.

  PMID: 37234382 BACKGROUND

• Jabir AI, Lin X, Martinengo L, Sharp G, Theng YL, Tudor Car L. Attrition in Conversational Agent-Delivered Mental Health Interventions: Systematic Review and Meta-Analysis. J Med Internet Res. 2024 Feb 27;26:e48168. doi: 10.2196/48168.

  PMID: 38412023 BACKGROUND

• Moore GF, Audrey S, Barker M, Bond L, Bonell C, Hardeman W, Moore L, O'Cathain A, Tinati T, Wight D, Baird J. Process evaluation of complex interventions: Medical Research Council guidance. BMJ. 2015 Mar 19;350:h1258. doi: 10.1136/bmj.h1258.

  PMID: 25791983 BACKGROUND

• Yan X, Ghosh P, Chakraborty B. Sample size calculation based on precision for pilot sequential multiple assignment randomized trial (SMART). Biom J. 2021 Feb;63(2):247-271. doi: 10.1002/bimj.201900364. Epub 2020 Jun 11.

  PMID: 32529788 BACKGROUND

• Zheng S, Castro O, Mair JL, Jabir AI, Tan SYX, Shenoi A, Negi S, Mathews RR, Soc RKWSB, Yan X, Chakraborty B, Tai ES, van Dam RM, von Wangenheim F, Fleisch E, Griva K, Kowatsch T, Muller-Riemenschneider F. Feasibility of the "LvL UP" trial: a pilot sequential multiple assignment randomised trial of an adaptive, holistic mHealth lifestyle coaching intervention. Int J Behav Nutr Phys Act. 2026 Jan 3. doi: 10.1186/s12966-025-01869-7. Online ahead of print.

  PMID: 41485014 DERIVED

• Castro O, Mair JL, Zheng S, Tan SYX, Jabir AI, Yan X, Chakraborty B, Tai ES, van Dam RM, von Wangenheim F, Fleisch E, Griva K, Kowatsch T, Muller-Riemenschneider F. The LvL UP trial: Protocol for a sequential, multiple assignment, randomised controlled trial to assess the effectiveness of a blended mobile lifestyle intervention. Contemp Clin Trials. 2025 Mar;150:107833. doi: 10.1016/j.cct.2025.107833. Epub 2025 Feb 1.

  PMID: 39900289 DERIVED

MeSH Terms

Conditions

Health Behavior; Noncommunicable Diseases; Risk Reduction Behavior; Motor Activity; Psychological Well-Being

Condition Hierarchy (Ancestors)

Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Personal Satisfaction

Study Officials

• Falk Mueller-Riemenschneider, Professor

  National University of Singapore

  PRINCIPAL INVESTIGATOR

• Tobias Kowatsch, Professor

  ETH Zurich

  PRINCIPAL INVESTIGATOR

• Konstantina Griva, Professor

  Nanyang Technological University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2024
• First Posted: April 11, 2024
• Study Start: April 15, 2024
• Primary Completion: July 9, 2024
• Study Completion: August 1, 2024
• Last Updated: September 26, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

SG (2)