- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06360029
The LvL UP Pilot Trial
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.
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).
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Oscar Castro, PhD
- Phone Number: +6585501126
- Email: oscar.castro@sec.ethz.ch
Study Contact Backup
- Name: Jacqueline Mair, PhD
- Email: jacqueline.mair@sec.ethz.ch
Study Locations
-
-
-
Singapore, Singapore, 117549
- Recruiting
- Saw Swee Hock School of Public Health
-
Contact:
- Shenglin Zheng, MSc
- Email: shenglin.zheng@u.nus.edu
-
Singapore, Singapore, 138602
- Active, not recruiting
- Singapore ETH Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: LvL UP
Downloading and using the LvL UP app
|
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. |
Experimental: LvL UP + MI
Downloading and using the LvL UP app + taking part in motivational interviewing support sessions
|
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:
|
Active Comparator: Comparison
Receiving healthy lifestyle and mental well-being resources from Singapore's Health Promotion Board
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mental well-being
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.
|
Baseline, week 4, week 8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subjective well-being
Time Frame: Baseline, week 4, week 8
|
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.
|
Baseline, week 4, week 8
|
Mental health (depression)
Time Frame: Baseline, week 4, week 8
|
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.
|
Baseline, week 4, week 8
|
Mental health (stress)
Time Frame: Baseline, week 4, week 8
|
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.
|
Baseline, week 4, week 8
|
Health-related quality of life
Time Frame: Baseline, week 8
|
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.
|
Baseline, week 8
|
Health behaviours (physical activity)
Time Frame: Baseline, week 4, week 8
|
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).
|
Baseline, week 4, week 8
|
Health behaviours (steps)
Time Frame: Throughout the study period (i.e., assessed every day during 8 weeks)
|
Smartphone-based steps
|
Throughout the study period (i.e., assessed every day during 8 weeks)
|
Health behaviours (diet 1)
Time Frame: Baseline, week 4, week 8
|
Assessed using a diet screener developed and validated in Singapore
|
Baseline, week 4, week 8
|
Health behaviours (diet 2)
Time Frame: Baseline, week 4, week 8
|
Modified 7-item Food Frequency Questionnaire (ad hoc)
|
Baseline, week 4, week 8
|
Health behaviours (sleep)
Time Frame: Baseline, week 8
|
Assessed using the Pittsburgh Sleep Quality Index (PSQI).
The total score ranges from 0 to 27, with higher scores indicating more acute sleep disturbances.
|
Baseline, week 8
|
Health behaviours (smoking and alcohol consumption)
Time Frame: Baseline, week 8
|
Assessed using a short quantity-frequency survey on smoking and alcohol consumption used in previous epidemiological studies
|
Baseline, week 8
|
Anthropometry (body weight)
Time Frame: Baseline, week 8
|
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.
|
Baseline, week 8
|
Anthropometry (body height)
Time Frame: Baseline, week 8
|
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.
|
Baseline, week 8
|
Anthropometry (waist circumference)
Time Frame: Baseline, week 8
|
During study visits research staff will assess participants' waist circumference in meters.
|
Baseline, week 8
|
Anthropometry (hip circumference)
Time Frame: Baseline, week 8
|
During study visits research staff will assess participants' hip circumference in meters.
|
Baseline, week 8
|
Anthropometry (self-reported height and weight)
Time Frame: week 4
|
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.
|
week 4
|
Resting blood pressure
Time Frame: Baseline, week 8
|
During study visits research staff will assess diastolic and systolic blood pressure using an automated blood pressure monitor (Dinamap - Carescape V100, GE Pacific).
|
Baseline, week 8
|
Blood metabolic profile
Time Frame: Baseline, week 8
|
During study visits research staff will collect a non-fasting venous blood sample to assess the following blood markers: TC, HDL, TG & LDL-calculated.
All measured as millimoles per liter (mmol/L).
|
Baseline, week 8
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
LvL UP app: Response time
Time Frame: Continuously throughout the study period (i.e., assessed every day during 8 weeks)
|
Timestamp when a message was sent by the app to the participant and the timestamp when an answer was provided by the participant
|
Continuously throughout the study period (i.e., assessed every day during 8 weeks)
|
LvL UP app: Duration of app usage
Time Frame: Continuously throughout the study period (i.e., assessed every day during 8 weeks)
|
Time measure of how long an individual had the app open
|
Continuously throughout the study period (i.e., assessed every day during 8 weeks)
|
LvL UP app: Actual usage of app components
Time Frame: Continuously throughout the study period (i.e., assessed every day during 8 weeks)
|
Timestamps combined with any interactions performed by the participant with the intervention components (coaching sessions, life hacks, Breeze, journaling)
|
Continuously throughout the study period (i.e., assessed every day during 8 weeks)
|
LvL UP app: Coaching topic / sub-topic use
Time Frame: Continuously throughout the study period (i.e., assessed every day during 8 weeks)
|
Which coaching topics were used by the participant
|
Continuously throughout the study period (i.e., assessed every day during 8 weeks)
|
LvL UP app: Conversational turns
Time Frame: Continuously throughout the study period (i.e., assessed every day during 8 weeks)
|
The number of responses of a participant divided by the number of conversational turns offered by the app's chatbot
|
Continuously throughout the study period (i.e., assessed every day during 8 weeks)
|
LvL UP app: Breeze (slow-paced breathing tool) usage
Time Frame: Continuously throughout the study period (i.e., assessed every day during 8 weeks)
|
Audio-recordings of short voice commands and breathing when using "Breeze" (slow-paced breathing tool)
|
Continuously throughout the study period (i.e., assessed every day during 8 weeks)
|
LvL UP app: Access to smartphone sensors (location - obfuscated)
Time Frame: Continuously throughout the study period (i.e., assessed every day during 8 weeks)
|
Sensor: GPS. Data type: Float.
|
Continuously throughout the study period (i.e., assessed every day during 8 weeks)
|
LvL UP app: Access to smartphone sensors (location types)
Time Frame: Continuously throughout the study period (i.e., assessed every day during 8 weeks)
|
Sensor: Apple SensorKit.
Data type: Categorical (work, home, gym).
|
Continuously throughout the study period (i.e., assessed every day during 8 weeks)
|
LvL UP app: Access to smartphone sensors (raw gyroscope)
Time Frame: Continuously throughout the study period (i.e., assessed every day during 8 weeks)
|
Sensor: Gyroscope.
Data type: Float.
|
Continuously throughout the study period (i.e., assessed every day during 8 weeks)
|
LvL UP app: Access to smartphone sensors (raw accelerometer)
Time Frame: Continuously throughout the study period (i.e., assessed every day during 8 weeks)
|
Sensor: Accelerometer.
Data type: Float.
|
Continuously throughout the study period (i.e., assessed every day during 8 weeks)
|
LvL UP app: Access to smartphone sensors (physical activity)
Time Frame: Continuously throughout the study period (i.e., assessed every day during 8 weeks)
|
Sensor: Accelerometer.
Data type: Categorical (sitting, standing, walking, in a vehicle, running or bicycling) .
|
Continuously throughout the study period (i.e., assessed every day during 8 weeks)
|
LvL UP app: Access to smartphone sensors (WiFi connection status)
Time Frame: Continuously throughout the study period (i.e., assessed every day during 8 weeks)
|
Sensor: WiFi.
Data type: Categorical (connected/disconnected) and String (name of network).
|
Continuously throughout the study period (i.e., assessed every day during 8 weeks)
|
LvL UP app: Access to smartphone sensors (WiFi networks in range)
Time Frame: Continuously throughout the study period (i.e., assessed every day during 8 weeks)
|
Sensor: WiFi.
Data type: String (name and device IDs of near-by WiFi Access Points).
|
Continuously throughout the study period (i.e., assessed every day during 8 weeks)
|
LvL UP app: Access to smartphone sensors (bluetooth scan)
Time Frame: Continuously throughout the study period (i.e., assessed every day during 8 weeks)
|
Sensor: Bluetooth.
Data type: String (name and device IDs of near-by devices).
|
Continuously throughout the study period (i.e., assessed every day during 8 weeks)
|
LvL UP app: Access to smartphone sensors (battery % level and charging status)
Time Frame: Continuously throughout the study period (i.e., assessed every day during 8 weeks)
|
Sensor: Battery Status.
Data type: Float representing battery level and Categorical (charging/discharging/none).
|
Continuously throughout the study period (i.e., assessed every day during 8 weeks)
|
LvL UP app: Access to smartphone sensors (screen on/off)
Time Frame: Continuously throughout the study period (i.e., assessed every day during 8 weeks)
|
Sensor: Screen Events.
Data type: Binary (on/off).
|
Continuously throughout the study period (i.e., assessed every day during 8 weeks)
|
LvL UP app: Access to smartphone sensors (call and SMS metadata)
Time Frame: Continuously throughout the study period (i.e., assessed every day during 8 weeks)
|
Sensor: Call/SMS logs.
Data type: Strings (containing hash of number), time, duration of call / length of text.
|
Continuously throughout the study period (i.e., assessed every day during 8 weeks)
|
LvL UP app: Access to smartphone sensors (app usage & app name from notifications and action)
Time Frame: Continuously throughout the study period (i.e., assessed every day during 8 weeks)
|
Sensor: App Usage.
Data type: String/Categorical (social, entertainment, communication, etc).
|
Continuously throughout the study period (i.e., assessed every day during 8 weeks)
|
LvL UP app: Access to smartphone sensors (step count)
Time Frame: Continuously throughout the study period (i.e., assessed every day during 8 weeks)
|
Sensor: Pedometer.
Data type: Integer.
|
Continuously throughout the study period (i.e., assessed every day during 8 weeks)
|
LvL UP app: Access to smartphone sensors (brightness)
Time Frame: Continuously throughout the study period (i.e., assessed every day during 8 weeks)
|
Sensor: Screen Brightness.
Data type: Integer.
|
Continuously throughout the study period (i.e., assessed every day during 8 weeks)
|
LvL UP app: Access to smartphone sensors (breeze audio)
Time Frame: Continuously throughout the study period (i.e., assessed every day during 8 weeks)
|
Sensor: Audio Mic.
Data type: Audio file during Breeze usage (slow-paced breathing tool).
|
Continuously throughout the study period (i.e., assessed every day during 8 weeks)
|
LvL UP app: Access to Apple Healthkit & Google Fit data
Time Frame: Continuously throughout the study period (i.e., assessed every day during 8 weeks) and up to 1 month before the start of the study
|
Including the following data types: activity, hearing, vital signs, nutrition, mobility, mindfulness and sleep, workouts
|
Continuously throughout the study period (i.e., assessed every day during 8 weeks) and up to 1 month before the start of the study
|
Process evaluation: Health literacy questionnaire
Time Frame: Baseline, week 8
|
Knowledge of physical activity and dietary guidelines (ad hoc)
|
Baseline, week 8
|
Process evaluation: Stages of change questionnaire
Time Frame: Baseline, week 8
|
Readiness to change physical activity, eating, and mental wellness habits
|
Baseline, week 8
|
Process evaluation: Unintended consequences
Time Frame: Week 8
|
Unintended consequences of participating in the trial (open-ended text box)
|
Week 8
|
Process evaluation (intervention group participants only): Net promoter score
Time Frame: Week 4
|
1-item rating via in-app pop-up: "How likely is it that you would recommend LvL UP to a friend?"
rating between 0 (not at all likely) and 10 (extremely likely).
|
Week 4
|
Process evaluation (intervention group participants only): System usability scale
Time Frame: Week 4
|
Scale giving a global view of subjective assessments towards the LvL UP app.
The total System usability scale score is calculated as a percentage, ranging from 0 to 100.
A perfect score of 100% signifies flawless usability and an exceptional user experience.
|
Week 4
|
Process evaluation (intervention group participants only): Session alliance inventory
Time Frame: Week 4, week 8
|
Measures the working alliance between participant and digital (LvL UP app) / MI coach.
The total score ranges from 12 to 84, with higher values indicating a more positive rating of working alliance.
|
Week 4, week 8
|
Process evaluation (intervention group participants only): Self-report habit index
Time Frame: Week 8
|
Measure of habit strength for domains targeted by LvL UP app
|
Week 8
|
Process evaluation (intervention group participants only): MITI-4
Time Frame: Week 8
|
Behavioral coding system designed to measure treatment fidelity for motivational interviewing
|
Week 8
|
Process evaluation (intervention group participants only): UMars
Time Frame: Week 8
|
User's assessment of quality of mHealth apps, including the following domains: Engagement, Functionality, Aesthetics, Information, App quality, App subjective quality.
All items are assessed on a 5-point scale (1-inadequate, 2-poor, 3-acceptable, 4-good, and 5-excellent).
|
Week 8
|
Process evaluation (intervention group participants only): Interview
Time Frame: Week 8
|
Process evaluation interview for a subset of participants exploring mechanisms of action, context, and implementation
|
Week 8
|
Process evaluation (Research team): Field Notes
Time Frame: Continuously throughout the study period (i.e., every day during 8 weeks)
|
To record any notable information that may impact the trial conduct or outcomes
|
Continuously throughout the study period (i.e., every day during 8 weeks)
|
Exploratory aims: Sociodemographic
Time Frame: Baseline
|
Age, sex, ethnicity, marital status, current employment status, occupation, completed years of education, accommodation type, and household income
|
Baseline
|
Exploratory aims: Use of digital health technologies
Time Frame: Baseline
|
Assessed using the a questionnaire on past/current use of wearables and participation in digital health programes (ad hoc)
|
Baseline
|
Exploratory aims: Ecologic Momentary Assessment of mood state
Time Frame: Every two days throughout the study period (i.e., during 8 weeks)
|
Assessed using a graphical question based on the circumplex model of affect.
|
Every two days throughout the study period (i.e., during 8 weeks)
|
Exploratory aims: Personality
Time Frame: Baseline
|
Assessed using the Big 5 Personality Questionnaire - short.
The questionnaire measures five traits (extraversion, agreeableness, openness, conscientiousness, and neuroticism), and consists of 20 items structured as simple sentences rated in the Likert scale of 5 points, ranging from 1 (totally disagree) to 5 (totally agree).
|
Baseline
|
Exploratory aims: Work Engagement
Time Frame: Baseline, week 8
|
Assessed using the Utrecht Work Engagement Scale (UWES-9), a nine-item scale grouped into three subscales: vigor, dedication, and absorption.
All items are scored on a seven-point frequency rating scale ranging from 0 (never) to 6 (always).
|
Baseline, week 8
|
Exploratory aims: Self-reported sickness absence
Time Frame: Baseline, week 8
|
Number of self-reported sickness absence days
|
Baseline, week 8
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Falk Mueller-Riemenschneider, Professor, National University of Singapore
- Principal Investigator: Tobias Kowatsch, Professor, ETH Zurich
- Principal Investigator: Konstantina Griva, Professor, Nanyang Technological University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LvL UP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Health Behavior
-
Holbaek SygehusRecruitingHealth Behavior | Health Knowledge, Attitudes, Practice | Health-Related Behavior | Health LiteracyDenmark
-
Finnish Institute for Health and WelfareCompletedHealth Behavior | Health Care Utilization | Health Care Seeking BehaviorFinland
-
Basque Health ServiceUnknownHealth Promotion | Health Behavior | Health Education | Patient Education | Counseling | Behavior TherapySpain
-
University Hospital, Basel, SwitzerlandSolidarMed LesothoRecruitingRecruitment | Health Behavior | Motivation | Social Behavior | Health Care Utilization | Consumer Behavior | Health Care Seeking Behavior | Researcher-Subject RelationsLesotho
-
Imperial College LondonRecruitingHealth Attitude | Disease | Cancer | Health Behavior | Health Knowledge, Attitudes, Practice | Health-Related BehaviorUnited Kingdom
-
Research on Healthcare Performance Lab U1290RecruitingStress | Health Behavior | Health-Related BehaviorFrance
-
Azienda Sanitaria Locale CN2 Alba-BraUniversity of Turin, Italy; University of Eastern Piedmont; Eclectica Sas di...CompletedEffectiveness of the Updated Version of the School-based Program Diario Della Salute (DDS-2) (DDS-2)Mental Health Wellness 1 | Health Behavior | Adolescent BehaviorItaly
-
Research on Healthcare Performance Lab U1290RecruitingSedentary Behavior | Sedentary Time | Health Behavior | Health-Related Behavior | Physical InactivityFrance
-
World Health OrganizationLondon School of Hygiene and Tropical Medicine; University of Ghana; Biomedical... and other collaboratorsRecruitingHealth-Related Behavior | Adolescent Behavior | Adolescent Development | Health Care Seeking BehaviorGhana, Tanzania, Zimbabwe
-
Ankara Yildirim Beyazıt UniversityNot yet recruitingHealth Attitude | Health Behavior | Health KnowledgeTurkey
Clinical Trials on LvL UP
-
Singapore Institute for Clinical SciencesRecruitingType 2 Diabetes | Gestational Diabetes | Healthy Lifestyle BehaviorsSingapore
-
Istanbul University - Cerrahpasa (IUC)CompletedInfertility | Psychological Distress | Infertility, Female | Depression, Anxiety | Nurse's RoleTurkey
-
Opti'MouvUniversité Grenoble-AlpesCompleted
-
Shannon E. Sauer-ZavalaCompletedDepressive Disorder | Obsessive-Compulsive Disorder | Anxiety Disorders | Post Traumatic Stress DisorderUnited States
-
Riphah International UniversityCompletedSports Physical TherapyPakistan
-
M.D. Anderson Cancer CenterRecruitingRecurrent Mantle Cell Lymphoma | Refractory Mantle Cell LymphomaUnited States
-
Shannon E. Sauer-ZavalaNational Institute of Mental Health (NIMH)Active, not recruitingObsessive-Compulsive Disorder | Anxiety Disorders | Post Traumatic Stress DisorderUnited States
-
Johns Hopkins UniversityCompletedCervical Cancer | Breast CancerUnited States
-
Connolly Hospital BlanchardstownCompletedGeneral Surgery | Outpatients | Virtual Clinic | Text MessagingIreland
-
University of PortsmouthTerminatedChronic Obstructive Pulmonary DiseaseUnited Kingdom