Clinical trial NCT06360029: The LvL UP Pilot 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behavior
Noncommunicable Diseases
Mental Health Issue
Lifestyle Risk Reduction
Keywords: Prevention
Healthy lifestyle
Physical activity
Diet
Mental well-being
Digital health interventions
Mobile Health
Lead sponsor: Singapore ETH Centre
Sponsor class: OTHER
Collaborators: name: ETH Zurich
name: National University of Singapore
name: Nanyang Technological University
First posted: 2024-04-11
Enrollment: 201
Sex: ALL
Minimum age (years): 21
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief summary: Non-communicable diseases (NCDs), such as cardiovascular disease, diabetes, or cancer, and common mental disorders (CMDs), such as depression or anxiety, represent the primary causes of death and disability worldwide, causing major health and financial burdens. Lifestyle behaviours, including physical activity, diet, stress and emotional regulation, tobacco smoking, alcohol consumption, and sleep are important modifiable risk factors associated with the prevention and management of both NCDs and CMDs.

LvL UP is a mHealth intervention aimed at preventing NCDs and CMDs in adults from multi-ethnic Southeast Asian populations (Castro et al., 2023). Building upon leading evidence- and theory-based frameworks in the areas of mental health and behaviour change, a multidisciplinary team of researchers developed LvL UP as a holistic intervention centred around three core pillars: Move More, Eat Well, Stress Less.

The goal of this pilot study is to assess the feasibility of a Sequential, Multiple Assignment, Randomized Trial (SMART) aimed at (i) evaluating the effectiveness and cost-effectiveness of LvL UP and (ii) establishing the optimal blended approach in LvL UP that balances effective personalized lifestyle support with scalability. The main questions it aims to answer are:

1. 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).

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Mental well-being (Warwick-Edinburgh Mental Well-being Scale)
timeFrame: Baseline, week 4, week 8
Secondary outcomes:
measure: Subjective well-being (World Health Organization Well-Being Index)
timeFrame: Baseline, week 4, week 8
measure: Mental health (depression - Patient Health Questionnaire-9)
timeFrame: Baseline, week 4, week 8
measure: Mental health (stress - Kessler Psychological Distress Scale)
timeFrame: Baseline, week 4, week 8
measure: Health-related quality of life (European Quality of Life 5 Dimensions 5 Level Version)
timeFrame: Baseline, week 8
measure: Health behaviours (physical activity - International Physical Activity Questionnaire)
timeFrame: Baseline, week 4, week 8
measure: Health behaviours (sleep - Pittsburgh Sleep Quality Index)
timeFrame: Baseline, week 8
measure: Health behaviours (number of steps - smartphone-based)
timeFrame: Throughout the study period (i.e., assessed every day during 8 weeks)
measure: Health behaviours (quantity and frequency of smoking and alcohol consumption - ad hoc questionnaire)
timeFrame: Baseline, week 8
measure: Anthropometry (body weight in kilograms)
timeFrame: Baseline, week 8
measure: Anthropometry (body height in meters)
timeFrame: Baseline, week 8
measure: Anthropometry (waist circumference in meters)
timeFrame: Baseline, week 8
measure: Anthropometry (hip circumference in meters)
timeFrame: Baseline, week 8
measure: Anthropometry (self-reported height in kilograms and weight in meters)
timeFrame: week 4
measure: Resting blood pressure in mmHg
timeFrame: Baseline, week 8
measure: Health behaviours (diet quality 1 - Singapore diet screener)
timeFrame: Baseline, week 4, week 8
measure: Health behaviours (diet quality 2 - ad hoc Food Frequency Questionnaire)
timeFrame: Baseline, week 4, week 8
measure: Blood metabolic profile (mmol/L concentration of TC, HDL, TG and LDL-calculated)
timeFrame: Baseline, week 8
Other outcomes:
measure: LvL UP app: Response time to app notifications
timeFrame: Continuously throughout the study period (i.e., assessed every day during 8 weeks)
measure: LvL UP app: Duration of app usage in minutes
timeFrame: Continuously throughout the study period (i.e., assessed every day during 8 weeks)
measure: LvL UP app: Actual usage of app components (number of times used and duration)
timeFrame: Continuously throughout the study period (i.e., assessed every day during 8 weeks)
measure: LvL UP app: Coaching topic / sub-topic use
timeFrame: Continuously throughout the study period (i.e., assessed every day during 8 weeks)
measure: LvL UP app: Conversational turns
timeFrame: Continuously throughout the study period (i.e., assessed every day during 8 weeks)
measure: LvL UP app: Breeze (slow-paced breathing tool) usage
timeFrame: Continuously throughout the study period (i.e., assessed every day during 8 weeks)
measure: LvL UP app: Access to smartphone sensors (location - obfuscated)
timeFrame: Continuously throughout the study period (i.e., assessed every day during 8 weeks)
measure: LvL UP app: Access to smartphone sensors (location types)
timeFrame: Continuously throughout the study period (i.e., assessed every day during 8 weeks)
measure: LvL UP app: Access to smartphone sensors (raw gyroscope)
timeFrame: Continuously throughout the study period (i.e., assessed every day during 8 weeks)
measure: LvL UP app: Access to smartphone sensors (raw accelerometer)
timeFrame: Continuously throughout the study period (i.e., assessed every day during 8 weeks)
measure: LvL UP app: Access to smartphone sensors (physical activity)
timeFrame: Continuously throughout the study period (i.e., assessed every day during 8 weeks)
measure: LvL UP app: Access to smartphone sensors (WiFi connection status)
timeFrame: Continuously throughout the study period (i.e., assessed every day during 8 weeks)
measure: LvL UP app: Access to smartphone sensors (WiFi networks in range)
timeFrame: Continuously throughout the study period (i.e., assessed every day during 8 weeks)
measure: LvL UP app: Access to smartphone sensors (bluetooth scan)
timeFrame: Continuously throughout the study period (i.e., assessed every day during 8 weeks)
measure: LvL UP app: Access to smartphone sensors (battery % level and charging status)
timeFrame: Continuously throughout the study period (i.e., assessed every day during 8 weeks)
measure: LvL UP app: Access to smartphone sensors (screen on/off)
timeFrame: Continuously throughout the study period (i.e., assessed every day during 8 weeks)
measure: LvL UP app: Access to smartphone sensors (call and SMS metadata)
timeFrame: Continuously throughout the study period (i.e., assessed every day during 8 weeks)
measure: LvL UP app: Access to smartphone sensors (app usage & app name from notifications and action)
timeFrame: Continuously throughout the study period (i.e., assessed every day during 8 weeks)
measure: LvL UP app: Access to smartphone sensors (step count)
timeFrame: Continuously throughout the study period (i.e., assessed every day during 8 weeks)
measure: LvL UP app: Access to smartphone sensors (brightness)
timeFrame: Continuously throughout the study period (i.e., assessed every day during 8 weeks)
measure: LvL UP app: Access to smartphone sensors (breeze audio)
timeFrame: Continuously throughout the study period (i.e., assessed every day during 8 weeks)
measure: LvL UP app: Access to Apple Healthkit & Google Fit data
timeFrame: Continuously throughout the study period (i.e., assessed every day during 8 weeks) and up to 1 month before the start of the study
measure: Process evaluation: Health literacy questionnaire
timeFrame: Baseline, week 8
measure: Process evaluation: Stages of change questionnaire
timeFrame: Baseline, week 8
measure: Process evaluation: Unintended consequences of participating in the trial (ad hoc)
timeFrame: Week 8
measure: Process evaluation (intervention group participants only): Net promoter score
timeFrame: Week 4
measure: Process evaluation (intervention group participants only): System usability scale for LvL UP app
timeFrame: Week 4
measure: Process evaluation (intervention group participants only): Session alliance inventory for LvL UP app and motivational interviewing coaching sessions
timeFrame: Week 4, week 8
measure: Process evaluation (human coaches): Behaviour Change Counselling Index
timeFrame: Week 8
measure: Process evaluation (intervention group participants only): User Version of the Mobile Application Rating Scale (uMARS) for LvL UP app
timeFrame: Week 8
measure: Process evaluation (intervention group participants only): Interview (ad hoc)
timeFrame: Week 8
measure: Process evaluation (Research team): Field Notes
timeFrame: Continuously throughout the study period (i.e., every day during 8 weeks)
measure: Exploratory aims: Sociodemographic (ad hoc)
timeFrame: Baseline
measure: Exploratory aims: Use of digital health technologies (ad hoc)
timeFrame: Baseline
measure: Exploratory aims: Ecologic Momentary Assessment of mood state (ad hoc)
timeFrame: Every two days throughout the study period (i.e., during 8 weeks)
measure: Exploratory aims: Personality (Big 5 Personality Questionnaire)
timeFrame: Baseline
measure: Exploratory aims: Work Engagement (Work Productivity and Activity Impairment Questionnaire)
timeFrame: Baseline, week 8
measure: Exploratory aims: Healthcare utilization (ad hoc)
timeFrame: Baseline, week 8
Locations:
city: Singapore
country: Singapore
facility: Saw Swee Hock School of Public Health
city: Singapore
country: Singapore
facility: Singapore ETH Center
Study officials:
affiliation: National University of Singapore
name: Falk Mueller-Riemenschneider, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: ETH Zurich
name: Tobias Kowatsch, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Nanyang Technological University
name: Konstantina Griva, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.