protocolSection identificationModule nctId: NCT06360029, orgStudyIdInfo id: LvL UP, briefTitle: The LvL UP Pilot Trial, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Singapore ETH Centre, class: OTHER, collaborators name: ETH Zurich, collaborators name: National University of Singapore, collaborators name: Nanyang Technological University, descriptionModule briefSummary: 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. 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. 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)., conditionsModule conditions: Health Behavior, conditions: Noncommunicable Diseases, conditions: Mental Health Issue, conditions: Lifestyle Risk Reduction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: LvL UP, interventions name: LvL UP + MI, interventions name: Comparison, outcomesModule primaryOutcomes measure: Mental well-being, secondaryOutcomes measure: Subjective well-being, secondaryOutcomes measure: Mental health (depression), secondaryOutcomes measure: Mental health (stress), secondaryOutcomes measure: Health-related quality of life, secondaryOutcomes measure: Health behaviours (physical activity), secondaryOutcomes measure: Health behaviours (steps), secondaryOutcomes measure: Health behaviours (diet 1), secondaryOutcomes measure: Health behaviours (diet 2), secondaryOutcomes measure: Health behaviours (sleep), secondaryOutcomes measure: Health behaviours (smoking and alcohol consumption), secondaryOutcomes measure: Anthropometry (body weight), secondaryOutcomes measure: Anthropometry (body height), secondaryOutcomes measure: Anthropometry (waist circumference), secondaryOutcomes measure: Anthropometry (hip circumference), secondaryOutcomes measure: Anthropometry (self-reported height and weight), secondaryOutcomes measure: Resting blood pressure, secondaryOutcomes measure: Blood metabolic profile, otherOutcomes measure: LvL UP app: Response time, otherOutcomes measure: LvL UP app: Duration of app usage, otherOutcomes measure: LvL UP app: Actual usage of app components, otherOutcomes measure: LvL UP app: Coaching topic / sub-topic use, otherOutcomes measure: LvL UP app: Conversational turns, otherOutcomes measure: LvL UP app: Breeze (slow-paced breathing tool) usage, otherOutcomes measure: LvL UP app: Access to smartphone sensors (location - obfuscated), otherOutcomes measure: LvL UP app: Access to smartphone sensors (location types), otherOutcomes measure: LvL UP app: Access to smartphone sensors (raw gyroscope), otherOutcomes measure: LvL UP app: Access to smartphone sensors (raw accelerometer), otherOutcomes measure: LvL UP app: Access to smartphone sensors (physical activity), otherOutcomes measure: LvL UP app: Access to smartphone sensors (WiFi connection status), otherOutcomes measure: LvL UP app: Access to smartphone sensors (WiFi networks in range), otherOutcomes measure: LvL UP app: Access to smartphone sensors (bluetooth scan), otherOutcomes measure: LvL UP app: Access to smartphone sensors (battery % level and charging status), otherOutcomes measure: LvL UP app: Access to smartphone sensors (screen on/off), otherOutcomes measure: LvL UP app: Access to smartphone sensors (call and SMS metadata), otherOutcomes measure: LvL UP app: Access to smartphone sensors (app usage & app name from notifications and action), otherOutcomes measure: LvL UP app: Access to smartphone sensors (step count), otherOutcomes measure: LvL UP app: Access to smartphone sensors (brightness), otherOutcomes measure: LvL UP app: Access to smartphone sensors (breeze audio), otherOutcomes measure: LvL UP app: Access to Apple Healthkit & Google Fit data, otherOutcomes measure: Process evaluation: Health literacy questionnaire, otherOutcomes measure: Process evaluation: Stages of change questionnaire, otherOutcomes measure: Process evaluation: Unintended consequences, otherOutcomes measure: Process evaluation (intervention group participants only): Net promoter score, otherOutcomes measure: Process evaluation (intervention group participants only): System usability scale, otherOutcomes measure: Process evaluation (intervention group participants only): Session alliance inventory, otherOutcomes measure: Process evaluation (intervention group participants only): Self-report habit index, otherOutcomes measure: Process evaluation (intervention group participants only): MITI-4, otherOutcomes measure: Process evaluation (intervention group participants only): UMars, otherOutcomes measure: Process evaluation (intervention group participants only): Interview, otherOutcomes measure: Process evaluation (Research team): Field Notes, otherOutcomes measure: Exploratory aims: Sociodemographic, otherOutcomes measure: Exploratory aims: Use of digital health technologies, otherOutcomes measure: Exploratory aims: Ecologic Momentary Assessment of mood state, otherOutcomes measure: Exploratory aims: Personality, otherOutcomes measure: Exploratory aims: Work Engagement, otherOutcomes measure: Exploratory aims: Self-reported sickness absence, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 59 Years, stdAges: ADULT, contactsLocationsModule locations facility: Saw Swee Hock School of Public Health, status: RECRUITING, city: Singapore, zip: 117549, country: Singapore, contacts name: Shenglin Zheng, MSc, role: CONTACT, email: shenglin.zheng@u.nus.edu, geoPoint lat: 1.28967, lon: 103.85007, locations facility: Singapore ETH Center, status: ACTIVE_NOT_RECRUITING, city: Singapore, zip: 138602, country: Singapore, geoPoint lat: 1.28967, lon: 103.85007, hasResults: False