The LvL UP Pilot Trial

Health Behavior Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06360029
• Other study ID #: LvL UP
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2024
• Est. completion date: June 2024

Study information

• Verified date: April 2024
• Source: Singapore ETH Centre
• Contact: Oscar Castro, PhD
• Phone: +6585501126
• Email: oscar.castro[@]sec.ethz.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 59 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• LvL UP
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 + MI
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).
• Comparison
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.

Locations

Country	Name	City	State
Singapore	Saw Swee Hock School of Public Health	Singapore
Singapore	Singapore ETH Center	Singapore

Sponsors (4)

Lead Sponsor	Collaborator
Singapore ETH Centre	ETH Zurich, Nanyang Technological University, National University of Singapore

Country where clinical trial is conducted

Singapore, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	LvL UP app: Response time	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)
Other	LvL UP app: Duration of app usage	Time measure of how long an individual had the app open	Continuously throughout the study period (i.e., assessed every day during 8 weeks)
Other	LvL UP app: Actual usage of app components	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)
Other	LvL UP app: Coaching topic / sub-topic use	Which coaching topics were used by the participant	Continuously throughout the study period (i.e., assessed every day during 8 weeks)
Other	LvL UP app: Conversational turns	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)
Other	LvL UP app: Breeze (slow-paced breathing tool) usage	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)
Other	LvL UP app: Access to smartphone sensors (location - obfuscated)	Sensor: GPS. Data type: Float.	Continuously throughout the study period (i.e., assessed every day during 8 weeks)
Other	LvL UP app: Access to smartphone sensors (location types)	Sensor: Apple SensorKit. Data type: Categorical (work, home, gym).	Continuously throughout the study period (i.e., assessed every day during 8 weeks)
Other	LvL UP app: Access to smartphone sensors (raw gyroscope)	Sensor: Gyroscope. Data type: Float.	Continuously throughout the study period (i.e., assessed every day during 8 weeks)
Other	LvL UP app: Access to smartphone sensors (raw accelerometer)	Sensor: Accelerometer. Data type: Float.	Continuously throughout the study period (i.e., assessed every day during 8 weeks)
Other	LvL UP app: Access to smartphone sensors (physical activity)	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)
Other	LvL UP app: Access to smartphone sensors (WiFi connection status)	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)
Other	LvL UP app: Access to smartphone sensors (WiFi networks in range)	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)
Other	LvL UP app: Access to smartphone sensors (bluetooth scan)	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)
Other	LvL UP app: Access to smartphone sensors (battery % level and charging status)	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)
Other	LvL UP app: Access to smartphone sensors (screen on/off)	Sensor: Screen Events. Data type: Binary (on/off).	Continuously throughout the study period (i.e., assessed every day during 8 weeks)
Other	LvL UP app: Access to smartphone sensors (call and SMS metadata)	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)
Other	LvL UP app: Access to smartphone sensors (app usage & app name from notifications and action)	Sensor: App Usage. Data type: String/Categorical (social, entertainment, communication, etc).	Continuously throughout the study period (i.e., assessed every day during 8 weeks)
Other	LvL UP app: Access to smartphone sensors (step count)	Sensor: Pedometer. Data type: Integer.	Continuously throughout the study period (i.e., assessed every day during 8 weeks)
Other	LvL UP app: Access to smartphone sensors (brightness)	Sensor: Screen Brightness. Data type: Integer.	Continuously throughout the study period (i.e., assessed every day during 8 weeks)
Other	LvL UP app: Access to smartphone sensors (breeze audio)	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)
Other	LvL UP app: Access to Apple Healthkit & Google Fit data	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
Other	Process evaluation: Health literacy questionnaire	Knowledge of physical activity and dietary guidelines (ad hoc)	Baseline, week 8
Other	Process evaluation: Stages of change questionnaire	Readiness to change physical activity, eating, and mental wellness habits	Baseline, week 8
Other	Process evaluation: Unintended consequences	Unintended consequences of participating in the trial (open-ended text box)	Week 8
Other	Process evaluation (intervention group participants only): Net promoter score	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
Other	Process evaluation (intervention group participants only): System usability scale	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
Other	Process evaluation (intervention group participants only): Session alliance inventory	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
Other	Process evaluation (intervention group participants only): Self-report habit index	Measure of habit strength for domains targeted by LvL UP app	Week 8
Other	Process evaluation (intervention group participants only): MITI-4	Behavioral coding system designed to measure treatment fidelity for motivational interviewing	Week 8
Other	Process evaluation (intervention group participants only): UMars	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
Other	Process evaluation (intervention group participants only): Interview	Process evaluation interview for a subset of participants exploring mechanisms of action, context, and implementation	Week 8
Other	Process evaluation (Research team): Field Notes	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)
Other	Exploratory aims: Sociodemographic	Age, sex, ethnicity, marital status, current employment status, occupation, completed years of education, accommodation type, and household income	Baseline
Other	Exploratory aims: Use of digital health technologies	Assessed using the a questionnaire on past/current use of wearables and participation in digital health programes (ad hoc)	Baseline
Other	Exploratory aims: Ecologic Momentary Assessment of mood state	Assessed using a graphical question based on the circumplex model of affect.	Every two days throughout the study period (i.e., during 8 weeks)
Other	Exploratory aims: Personality	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
Other	Exploratory aims: Work Engagement	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
Other	Exploratory aims: Self-reported sickness absence	Number of self-reported sickness absence days	Baseline, week 8
Primary	Mental well-being	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	Subjective well-being	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
Secondary	Mental health (depression)	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
Secondary	Mental health (stress)	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
Secondary	Health-related quality of life	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
Secondary	Health behaviours (physical activity)	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
Secondary	Health behaviours (steps)	Smartphone-based steps	Throughout the study period (i.e., assessed every day during 8 weeks)
Secondary	Health behaviours (diet 1)	Assessed using a diet screener developed and validated in Singapore	Baseline, week 4, week 8
Secondary	Health behaviours (diet 2)	Modified 7-item Food Frequency Questionnaire (ad hoc)	Baseline, week 4, week 8
Secondary	Health behaviours (sleep)	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
Secondary	Health behaviours (smoking and alcohol consumption)	Assessed using a short quantity-frequency survey on smoking and alcohol consumption used in previous epidemiological studies	Baseline, week 8
Secondary	Anthropometry (body weight)	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
Secondary	Anthropometry (body height)	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
Secondary	Anthropometry (waist circumference)	During study visits research staff will assess participants' waist circumference in meters.	Baseline, week 8
Secondary	Anthropometry (hip circumference)	During study visits research staff will assess participants' hip circumference in meters.	Baseline, week 8
Secondary	Anthropometry (self-reported height and weight)	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
Secondary	Resting blood pressure	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
Secondary	Blood metabolic profile	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