Health BehaviorNCT06360029
The LvL UP Pilot Trial
A study testing LvL UP, LvL UP + MI and Comparison in people with Health Behavior and Noncommunicable Diseases, run by Singapore ETH Centre at 2 sites in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Behavior, Noncommunicable Diseases, Mental Health Issue
- What is being tested?
- LvL UP, LvL UP + MI and Comparison
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 2 sitesSingapore
- Study dates
- 15 Apr 2024to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Singapore2 sites
Saw Swee Hock School of Public Health
Singapore, 117549
Singapore ETH Center
Singapore, 138602
About this study
Official title: The LvL UP Pilot Trial: Assessing the Feasibility of a Sequential, Multiple Assignment, Randomized Controlled Trial to Evaluate the Effectiveness of a Blended Mobile Lifestyle Intervention
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.
Read more
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:
- 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?
- 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).
Read the detailed description
Participants will:
- Visit the study site at baseline and week 8 to complete assessments.
- Complete an online assessment at week 4.
- Be assigned to group 1 (intervention) or group 2 (comparison).
- Participants in group 1 will download the LvL UP App.
- Participants in group 1 categorized as 'non-responders' at week 4 will receive four motivational interviewing coaching sessions in addition to continue using the LvL UP app (LvL UP + MI).
- Participants in group 2 will receive a package with standard lifestyle resources from Singapore's Health Promotion Board.
Participants will be randomly allocated to groups 1 or 2 (LvL UP or comparison) following a 2:1 ratio favoring the LvL UP group. At week 4 (decision point), participants from the LvL UP group will be classified as responders or non-responders based on pre-specified criteria. Non-responder participants will be re-randomized with equal probability (1:1) to one of the two second-line conditions: (i) continuing with the initial intervention (LvL UP) or (ii) additional MI support sessions (LvL UP + MI). Response / non-response categorization will involve assessing preliminary intervention effects (positive change in one of the following: physical activity, diet or mental well-being) as well as satisfaction with the intervention (net promoter score).
Participants will also take part in a process evaluation informed by the UK Medical Research Council's guidelines (Moore et al., 2015) to explore implementation (process, fidelity, dose, adaptations, reach), mechanisms of action (participant experience and response to intervention, mediators, unexpected pathways and consequences), and contextual factors that may affect implementation and intervention outcomes. Methods will entail qualitative and quantitative approaches, including surveys, interviews, web-based and app-based analytic data, and direct observation. In addition, other measures have been added to the research protocol to address the following exploratory aims: (i) explore time-varying and baseline moderators on intervention outcomes (e.g., sociodemographic variables, personality), (ii) identify the most cost-effective intervention condition from the societal perspective (e.g., self-reported sickness absence), and (iii) investigate which LvL UP app and smartphone sensor data (e.g., usage patterns, location) might be effective in predicting participant's engagement, state of receptivity to LvL UP notifications, or state of vulnerability (mental health conditions). All measures are described in the outcomes section.
To formalize the sample size calculations for the pilot study, the precision-based approach by Yan et al. (2020) was used to ensure the estimated outcomes for LvL UP and LvL UP + MI are controlled within a certain precision (i.e., the margin of error as a proportion of the outcome's standard deviation). Assuming a 50% responder rate, a two-tailed Type I error of 5% and a precision of 30%, a total of 97 participants will be required. Taking an 82% retention estimate for digital health interventions lasting ≤8 weeks (Jabir et al., 2023) and rounding up the number, 120 participants will be recruited. Therefore, 40 and 80 participants will be randomly assigned to the comparison condition (group 2) and LvL UP (group 1), respectively. In addition, an estimated 40 participants from group intervention will be re-randomized to continue with LvL UP or have LvL UP + MI. Considering participants assigned to group 1 are asked to nominate a LvL UP Buddy, which will be part of the process evaluation of the trial and thus technically considered participants, the total estimated sample size is 200 (120 trial participants and 60 LvL UP Buddies).
- Being tested
- LvL UP, LvL UP + MI, Comparison
- Keywords
- Prevention, Healthy lifestyle, Physical activity, Diet, Mental well-being, Digital health interventions, Mobile Health
- Medical subject headings
- Health Behavior, Noncommunicable Diseases, Risk Reduction Behavior, Motor Activity, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LvL UPBehavioural
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 + MIBehavioural
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).
ComparisonBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| LvL UP | Experimental | Downloading and using the LvL UP app Receives: Behavioral: LvL UP |
| LvL UP + MI | Experimental | Downloading and using the LvL UP app + taking part in motivational interviewing support sessions Receives: Behavioral: LvL UP + MI |
| Comparison | Active comparator | Receiving healthy lifestyle and mental well-being resources from Singapore's Health Promotion Board Receives: Behavioral: Comparison |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, week 4, week 8
Secondary outcomes (17)
Subjective well-being (World Health Organization Well-Being Index)
Assessed using the World Health Organization Well-Being Index (WHO-5). The total score ranges from 0 to 25, with higher values indicating higher well-being.
Measured: Baseline, week 4, week 8
Mental health (depression - Patient Health Questionnaire-9)
Assessed using the Patient Health Questionnaire-9. The total score ranges from 0 to 27. Scores of 0-4, 5-9, 10-14, 15-19, 20-27 are the ranges for none, mild, moderate, moderately severe and severe depression, respectively.
Measured: Baseline, week 4, week 8
Mental health (stress - Kessler Psychological Distress Scale)
Assessed using the Kessler Psychological Distress Scale (K6). The total score ranges from 10 to 50, with higher values indicating higher levels of psychological distress.
Measured: Baseline, week 4, week 8
Health-related quality of life (European Quality of Life 5 Dimensions 5 Level Version)
Assessed using the European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L). The EQ-5D-5L descriptive system of 5 health dimensions (Mobility, Self-care, Usual activities, Pain / discomfort, Anxiety / depression) includes 5 response categories of no problem, slight problems, moderate problems, severe problems, and extreme problems. Health states are scored to give the EQ-5D-5L index using a scoring algorithm from a value set derived from valuation tasks undertaken with general population samples.
Measured: Baseline, week 8
Health behaviours (physical activity - International Physical Activity Questionnaire)
Assessed using the International Physical Activity Questionnaire (IPAQ-long). Results can be reported in categories (low activity levels, moderate activity levels or high activity levels) or as a continuous variable (MET minutes a week).
Measured: Baseline, week 4, week 8
Health behaviours (sleep - Pittsburgh Sleep Quality Index)
Assessed using the Pittsburgh Sleep Quality Index (PSQI). The total score ranges from 0 to 27, with higher scores indicating more acute sleep disturbances.
Measured: Baseline, week 8
Health behaviours (number of steps - smartphone-based)
Smartphone-based steps
Measured: Throughout the study period (i.e., assessed every day during 8 weeks)
Health behaviours (quantity and frequency of smoking and alcohol consumption - ad hoc questionnaire)
Assessed using a quantity-frequency survey on smoking and alcohol consumption adapted from previous epidemiological studies
Measured: Baseline, week 8
Anthropometry (body weight in kilograms)
During study visits research staff will assess participants' body weight in kilograms. Weight and height will be combined to report Body Mass Index (BMI) in kg/m2.
Measured: Baseline, week 8
Anthropometry (body height in meters)
During study visits research staff will assess participants' body height in meters. Weight and height will be combined to report Body Mass Index (BMI) in kg/m2.
Measured: Baseline, week 8
Anthropometry (waist circumference in meters)
During study visits research staff will assess participants' waist circumference in meters.
Measured: Baseline, week 8
Anthropometry (hip circumference in meters)
During study visits research staff will assess participants' hip circumference in meters.
Measured: Baseline, week 8
Anthropometry (self-reported height in kilograms and weight in meters)
Self-reported height (kilograms) and weight (meters) via online survey. Weight and height will be combined to report Body Mass Index (BMI) in kg/m2.
Measured: week 4
Resting blood pressure in mmHg
During study visits research staff will assess diastolic and systolic blood pressure (mmHg) using an automated blood pressure monitor (Dinamap - Carescape V100, GE Pacific).
Measured: Baseline, week 8
Health behaviours (diet quality 1 - Singapore diet screener)
Assessed using a 37-item diet screener developed and validated in Singapore
Measured: Baseline, week 4, week 8
Health behaviours (diet quality 2 - ad hoc Food Frequency Questionnaire)
Modified 7-item food frequency questionnaire (ad hoc) assessing diet quality
Measured: Baseline, week 4, week 8
Blood metabolic profile (mmol/L concentration of TC, HDL, TG and LDL-calculated)
During study visits research staff will collect a non-fasting venous blood sample to assess the following blood markers: TC, HDL, TG and LDL-calculated. All measured as millimoles per liter (mmol/L).
Measured: Baseline, week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start15 Apr 2024
- Primary completion9 Jul 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore ETH Centre
- Sponsor type
- University, hospital or other
- Collaborators
- ETH Zurich, National University of Singapore, Nanyang Technological University
- Responsible party
- Sponsor
- Investigators
- Falk Mueller-Riemenschneider, Professor, Principal investigator, National University of SingaporeTobias Kowatsch, Professor, Principal investigator, ETH ZurichKonstantina Griva, Professor, Principal investigator, Nanyang Technological University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06360029
- Sponsor's protocol ID
- LvL UP
- Status last verified
- Sep 2024
- First submitted
- 1 Apr 2024
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37234382Jabir 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.
PubMed 38412023Moore 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.
PubMed 25791983Yan 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.
PubMed 32529788Zheng S, Castro O, Mair JL, Jabir AI, Tan SYX, Shenoi A, Negi S, Mathews RR, Koh RWS, 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;23(1):16. doi: 10.1186/s12966-025-01869-7.
PubMed 41485014Castro 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.
PubMed 39900289
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The LvL UP Pilot Trial: Assessing the Feasibility of a Sequential, Multiple Assignment, Randomized Controlled Trial to Evaluate the Effectiveness of a Blended Mobile Lifestyle Intervention
- ClinicalTrials.gov ID
- NCT06360029
- Acronym / sponsor ID
- LvL UP
- Keywords
- Prevention, Healthy lifestyle, Physical activity, Diet, Mental well-being, Digital health interventions, Mobile Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Singapore ETH CentreUniversity, hospital or other
- Collaborators
- ETH Zurich, National University of Singapore, Nanyang Technological University
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 9 Jul 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 11 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
- 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).
Detailed description
Participants will:
- Visit the study site at baseline and week 8 to complete assessments.
- Complete an online assessment at week 4.
- Be assigned to group 1 (intervention) or group 2 (comparison).
- Participants in group 1 will download the LvL UP App.
- Participants in group 1 categorized as 'non-responders' at week 4 will receive four motivational interviewing coaching sessions in addition to continue using the LvL UP app (LvL UP + MI).
- Participants in group 2 will receive a package with standard lifestyle resources from Singapore's Health Promotion Board.
Participants will be randomly allocated to groups 1 or 2 (LvL UP or comparison) following a 2:1 ratio favoring the LvL UP group. At week 4 (decision point), participants from the LvL UP group will be classified as responders or non-responders based on pre-specified criteria. Non-responder participants will be re-randomized with equal probability (1:1) to one of the two second-line conditions: (i) continuing with the initial intervention (LvL UP) or (ii) additional MI support sessions (LvL UP + MI). Response / non-response categorization will involve assessing preliminary intervention effects (positive change in one of the following: physical activity, diet or mental well-being) as well as satisfaction with the intervention (net promoter score).
Participants will also take part in a process evaluation informed by the UK Medical Research Council's guidelines (Moore et al., 2015) to explore implementation (process, fidelity, dose, adaptations, reach), mechanisms of action (participant experience and response to intervention, mediators, unexpected pathways and consequences), and contextual factors that may affect implementation and intervention outcomes. Methods will entail qualitative and quantitative approaches, including surveys, interviews, web-based and app-based analytic data, and direct observation. In addition, other measures have been added to the research protocol to address the following exploratory aims: (i) explore time-varying and baseline moderators on intervention outcomes (e.g., sociodemographic variables, personality), (ii) identify the most cost-effective intervention condition from the societal perspective (e.g., self-reported sickness absence), and (iii) investigate which LvL UP app and smartphone sensor data (e.g., usage patterns, location) might be effective in predicting participant's engagement, state of receptivity to LvL UP notifications, or state of vulnerability (mental health conditions). All measures are described in the outcomes section.
To formalize the sample size calculations for the pilot study, the precision-based approach by Yan et al. (2020) was used to ensure the estimated outcomes for LvL UP and LvL UP + MI are controlled within a certain precision (i.e., the margin of error as a proportion of the outcome's standard deviation). Assuming a 50% responder rate, a two-tailed Type I error of 5% and a precision of 30%, a total of 97 participants will be required. Taking an 82% retention estimate for digital health interventions lasting ≤8 weeks (Jabir et al., 2023) and rounding up the number, 120 participants will be recruited. Therefore, 40 and 80 participants will be randomly assigned to the comparison condition (group 2) and LvL UP (group 1), respectively. In addition, an estimated 40 participants from group intervention will be re-randomized to continue with LvL UP or have LvL UP + MI. Considering participants assigned to group 1 are asked to nominate a LvL UP Buddy, which will be part of the process evaluation of the trial and thus technically considered participants, the total estimated sample size is 200 (120 trial participants and 60 LvL UP Buddies).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LvL UP | Experimental | Behavioral: LvL UPDownloading and using the LvL UP app |
| LvL UP + MI | Experimental | Behavioral: LvL UP + MIDownloading and using the LvL UP app + taking part in motivational interviewing support sessions |
| Comparison | Active comparator | Behavioral: ComparisonReceiving healthy lifestyle and mental well-being resources from Singapore's Health Promotion Board |
Who may qualify
- Ages
- 21 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LvL UPThe 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. | Behavioural | LvL UP |
| LvL UP + MIAfter 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). | Behavioural | LvL UP + MI |
| ComparisonParticipants 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. | Behavioural | Comparison |
Primary outcome
Mental well-being (Warwick-Edinburgh Mental Well-being Scale)
Time frame: Baseline, week 4, week 8
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.
17 secondary outcomes
Subjective well-being (World Health Organization Well-Being Index)
Time frame: Baseline, week 4, week 8
Mental health (depression - Patient Health Questionnaire-9)
Time frame: Baseline, week 4, week 8
Mental health (stress - Kessler Psychological Distress Scale)
Time frame: Baseline, week 4, week 8
Health-related quality of life (European Quality of Life 5 Dimensions 5 Level Version)
Time frame: Baseline, week 8
Health behaviours (physical activity - International Physical Activity Questionnaire)
Time frame: Baseline, week 4, week 8
Health behaviours (sleep - Pittsburgh Sleep Quality Index)
Time frame: Baseline, week 8
Health behaviours (number of steps - smartphone-based)
Time frame: Throughout the study period (i.e., assessed every day during 8 weeks)
Health behaviours (quantity and frequency of smoking and alcohol consumption - ad hoc questionnaire)
Time frame: Baseline, week 8
Anthropometry (body weight in kilograms)
Time frame: Baseline, week 8
Anthropometry (body height in meters)
Time frame: Baseline, week 8
Anthropometry (waist circumference in meters)
Time frame: Baseline, week 8
Anthropometry (hip circumference in meters)
Time frame: Baseline, week 8
Anthropometry (self-reported height in kilograms and weight in meters)
Time frame: week 4
Resting blood pressure in mmHg
Time frame: Baseline, week 8
Health behaviours (diet quality 1 - Singapore diet screener)
Time frame: Baseline, week 4, week 8
Health behaviours (diet quality 2 - ad hoc Food Frequency Questionnaire)
Time frame: Baseline, week 4, week 8
Blood metabolic profile (mmol/L concentration of TC, HDL, TG and LDL-calculated)
Time frame: Baseline, week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
- Background: PubMed 37234382Castro 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.
- Background: PubMed 38412023Jabir 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.
- Background: PubMed 25791983Moore 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.
- Background: PubMed 32529788Yan 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.
- Derived from this study: PubMed 41485014Zheng S, Castro O, Mair JL, Jabir AI, Tan SYX, Shenoi A, Negi S, Mathews RR, Koh RWS, 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;23(1):16. doi: 10.1186/s12966-025-01869-7.
- Derived from this study: PubMed 39900289Castro 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Falk Mueller-Riemenschneider, Professor principal investigator
National University of Singapore
Tobias Kowatsch, Professor principal investigator
ETH Zurich
Konstantina Griva, Professor principal investigator
Nanyang Technological University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LvL UP, LvL UP + MI and Comparison in people with Health Behavior and Noncommunicable Diseases, run by Singapore ETH Centre at 2 sites in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mental well-being (Warwick-Edinburgh Mental Well-being Scale) (time frame: Baseline, week 4, week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06360029, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2024.