Clinical trial NCT06592443: The LvL UP Trial: Assessing the Effectiveness of a MHealth Intervention
Official title: The LvL UP Trial: a Sequential, Multiple Assignment, Randomized Controlled 2 Trial to Assess the Effectiveness of a Blended Mobile Lifestyle Intervention
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
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: 2024-09-19
Enrollment: 1073
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. 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.

This study is aimed at (i) evaluating the effectiveness and cost-effectiveness of LvL UP, an mHealth lifestyle intervention for the prevention of NCDs and CMDs, and (ii) establishing the optimal blended approach in LvL UP that balances effective personalized lifestyle support with scalability.

Detailed description: Participants will:

* Visit the study site at baseline and month 6 to complete assessments.
* Complete online assessments at months 1, 3, 9 and 12.
* 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 month 1 will start receiving six 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 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 month 1 (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). The LvL UP pilot study results (NCT06360029) will be used to inform the tailoring variable(s) for the trial (i.e., to define response / non-response at month 1). Engagement and app evaluation variables (e.g., number of app components completed over the first 4 weeks, net promoter score), preliminary intervention effects (e.g., initial positive response), or a combination of the two will be used.

Participants will also take part in a process evaluation informed by the UK Medical Research Council guidelines 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 (all relevant measures are described in the outcomes section):

A. To identify the most cost-effective intervention condition from the societal perspective (e.g., self-reported sickness absence).

B. To explore time-varying and baseline moderators on intervention outcomes (e.g., sociodemographic variables, personality).

C. To investigate behavior maintenance by assessing the intervention outcomes at six months of follow-up (i.e., 12 months after baseline).

D. To investigate which smartphone sensor data might be effective in predicting user state of receptivity to LvL UP notifications (receptivity: the likelihood of engaging with a LvL UP notification, operationalized as higher response rate and decreased response time).

E. To investigate which signals (e.g., audio signals, usage patterns) are most useful for predicting the presence of subclinical depression, anxiety, stress and/or other mental health conditions.

F. To validate a 7-day modified Food Frequency Questionnaire based on My Healthy Plate recommendations by Singapore Health Promotion Board (HPB).

G. To develop and evaluate a supervised non-responder / dropout prediction model using retrospective user app engagement data from the trial.

H. To explore views on climate and climate change and assess their perceived impact (including impact on health behaviours).

The study was powered to compare the baseline to 6 months change in mental well-being between LvL UP (A+B) and the comparison condition and between LvL UP + adaptive MI (A+C) versus the comparison condition (primary objective). For both comparisons, we assume the effect size (Cohen's d) for well-being to be 0.3 and the responder rate to stage 1 intervention (LvL UP) to be 50%. The effect size was estimated by aggregating data from five meta-analyses on mHealth interventions and their reported impact on participant's mental well-being. To obtain a marginal power of at least 80% with a two-tailed Type I error rate of 5% for each outcome, 458 participants will be required; we further buffer for 73% retention following a recent meta-analysis estimate for digital health interventions lasting more than 8 weeks, rounding the number for a final sample size of 650. Therefore, 217 participants will be randomized to the comparison condition, and 433 participants will be randomized to start with stage 1 intervention (LvL UP), of which we estimate about 217 participants (50% non-responders) will be re-randomized to either continue with LvL UP or receive MI at stage 2 (LvL UP + adaptive MI). Participants randomized to group 1 (LvL UP) are asked to nominate a LvL UP Buddy, which will take part in the process evaluation. The total sample size is thus 1,073 (650 as main participants and 423 as LvL UP Buddies). The above sample size calculations might be refined based on the LvL UP pilot study results.

Eligibility criteria: Inclusion Criteria:

(i) aged 21 to 59 years,

(ii) Singapore citizens, permanent residents, or foreigners residing in Singapore on long-term passes with at least 1 year of validity remaining,

(iii) planning to reside in Singapore for the duration of the study (eligible participants can undertake sporadic trips overseas, as long as these do not conflict with in-person study visits),

(iv) proficient in English (the LvL UP app is currently only available in English),

(v) owners of a smartphone (minimum requirements: iOS version 12.4 and Android version 8) with internet access,

(vi) able to provide informed consent, and

(vii) identified as 'at risk' of developing non-communicable diseases and/or common mental disorders.

Exclusion Criteria:

(i) diagnosed with one of the following chronic diseases: heart disease (e.g., heart attack and stroke), cancer, chronic respiratory diseases (e.g., chronic obstructed pulmonary disease and asthma), diabetes (type 1 or type 2), or chronic kidney disease.

(ii) diagnosed with one of the following mental disorders: major depressive disorders (depression), bipolar, eating disorders, post-traumatic stress disorder (PTSD), anxiety disorders, severe personality disorder, substance use disorders, or other mental health conditions diagnosed by a mental health professional.

(iii) pregnant, (iv) currently taking medications prescribed for high blood pressure or high blood glucose.

(v) past or current LvL UP users, including participants from the LvL UP pilot trial (NCT06360029) or HAPPY trial (Harnessing Human Potential and Improving Health Span in Women and their Children Trial).

(vi) already participating or planning to participate in the LvL UP trial as a 'LvL UP Buddy\&#39;.

(vii) enrolled or planning to enroll in another lifestyle intervention research study before or during the study period.

Primary outcomes:
measure: Mental well-being (Warwick-Edinburgh Mental Well-being Scale)
timeFrame: Baseline, month 1, month 3, month 6, month 9, month 12
Secondary outcomes:
measure: Subjective well-being (World Health Organization Well-Being Index)
timeFrame: Baseline, month 1, month 3, month 6, month 9, month 12
measure: Mental health (depression - Patient Health Questionnaire-9)
timeFrame: Baseline, month 1, month 3, month 6, month 9, month 12
measure: Mental health (stress - Kessler Psychological Distress Scale)
timeFrame: Baseline, month 1, month 3, month 6, month 9, month 12
measure: Health-related quality of life (European Quality of Life 5 Dimensions 5 Level Version)
timeFrame: Baseline, month 3, month 6, month 9, month 12
measure: Health behaviours (physical activity - International Physical Activity Questionnaire)
timeFrame: Baseline, month 1, month 3, month 6, month 9, month 12
measure: Health behaviours (steps - smartphone-based)
timeFrame: Throughout the study period (i.e., assessed every day during 12 months)
measure: Health behaviours (sleep - Pittsburgh Sleep Quality Index)
timeFrame: Baseline, month 6, month 12
measure: Health behaviours (smoking and alcohol consumption - ad hoc questionnaire)
timeFrame: Baseline, month 6, month 12
measure: Anthropometry (body weight)
timeFrame: Baseline, month 6
measure: Anthropometry (body height)
timeFrame: Baseline, month 6
measure: Anthropometry (waist circumference)
timeFrame: Baseline, month 6
measure: Anthropometry (hip circumference)
timeFrame: Baseline, month 6
measure: Anthropometry (body composition)
timeFrame: Baseline, month 6
measure: Anthropometry (self-reported height and weight)
timeFrame: month 1, month 3, month 9, month 12
measure: Resting blood pressure
timeFrame: Baseline, month 6
measure: Health behaviours (diet quality 1 - diet screener)
timeFrame: Baseline, month 1, month 3, month 6, month 9, month 12
measure: Health behaviours (diet quality 2 - ad hoc Food Frequency Questionnaire)
timeFrame: Baseline, month 1, month 3, month 6, month 9, month 12
measure: Blood metabolic profile (concentration of albumin, creatinine, DHEA-S, HbA1c, hsCRP, TC, HDL, TG, LDL-calculated, random glucose, and full blood count)
timeFrame: Baseline, month 6
measure: Blood metabolic profile (food intake and health status)
timeFrame: Baseline, month 6
measure: Self-reported health status
timeFrame: Baseline, month 3, month 6, month 9, month 12
measure: Change in health status
timeFrame: Baseline, month 3, month 6, month 9, month 12
Other outcomes:
measure: LvL UP app: Access to smartphone sensors (physical activity)
timeFrame: Continuously throughout the study period (i.e., assessed every day during 12 months)
measure: LvL UP app: Access to smartphone sensors (WiFi connection status)
timeFrame: Continuously throughout the study period (i.e., assessed every day during 12 months)
measure: LvL UP app: Access to smartphone sensors (WiFi networks in range)
timeFrame: Continuously throughout the study period (i.e., assessed every day during 12 months)
measure: LvL UP app: Access to smartphone sensors (bluetooth scan)
timeFrame: Continuously throughout the study period (i.e., assessed every day during 12 months)
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 12 months)
measure: LvL UP app: Access to smartphone sensors (screen on/off)
timeFrame: Continuously throughout the study period (i.e., assessed every day during 12 months)
measure: LvL UP app: Access to smartphone sensors (call and SMS metadata)
timeFrame: Continuously throughout the study period (i.e., assessed every day during 12 months)
measure: LvL UP app: Access to smartphone sensors (app usage &amp;amp; app name from notifications and action)
timeFrame: Continuously throughout the study period (i.e., assessed every day during 12 months)
measure: LvL UP app: Access to smartphone sensors (step count)
timeFrame: Continuously throughout the study period (i.e., assessed every day during 12 months)
measure: LvL UP app: Access to smartphone sensors (brightness)
timeFrame: Continuously throughout the study period (i.e., assessed every day during 12 months)
measure: LvL UP app: Access to smartphone sensors (breeze audio)
timeFrame: Continuously throughout the study period (i.e., assessed every day during 12 months)
measure: LvL UP app: Access to Apple Healthkit &amp;amp; Google Fit data
timeFrame: Continuously throughout the study period (i.e., assessed every day during 12 months) and up to 1 year before the start of the study
measure: Process evaluation: Health literacy questionnaire
timeFrame: Baseline, month 6
measure: Process evaluation: Stages of change questionnaire
timeFrame: Baseline, month 6
measure: Process evaluation: Exit survey (satisfaction and unexpected consequences)
timeFrame: Month 6
measure: Process evaluation: Self-efficacy
timeFrame: Month 6
measure: Process evaluation (intervention group participants only): System usability scale
timeFrame: Month 1
measure: Process evaluation (intervention group participants only): Session alliance inventory
timeFrame: Month 1, month 3
measure: Process evaluation (human coaches): Behaviour Change Counselling Index
timeFrame: Month 3, month 6
measure: Process evaluation (intervention group participants only): UMars
timeFrame: Month 6
measure: Process evaluation (intervention group participants only): Interview
timeFrame: Month 9
measure: Process evaluation (intervention group participants only): LvL UP Buddy support survey
timeFrame: Month 3, month 6
measure: Process evaluation (LvL UP Buddy participants only): LvL UP Buddy Survey
timeFrame: Month 3, month 6
measure: Process evaluation (LvL UP Buddy participants only): LvL UP Buddy WhatsApp Check-in
timeFrame: Every week for 6 months
measure: Process evaluation (Research team): Field Notes
timeFrame: Continuously throughout the study period (i.e., 12 months)
measure: Exploratory aims: Sociodemographic
timeFrame: Baseline
measure: Exploratory aims: Use of digital health technologies
timeFrame: Baseline, month 6, month 9, month 12
measure: Exploratory aims: Personality (Big 5 Personality Questionnaire)
timeFrame: Baseline
measure: Exploratory aims: Work Engagement (Work Productivity and Activity Impairment Questionnaire)
timeFrame: Baseline, month 3, month 6, month 9, month 12
measure: Exploratory aims: Healthcare utilization
timeFrame: Baseline, month 3, month 6, month 9, month 12
measure: Exploratory aims: Climate change and effects on health behaviours
timeFrame: Baseline, month 6
measure: LvL UP app: Response time
timeFrame: Continuously throughout the study period (i.e., assessed every day during 12 months)
measure: LvL UP app: Duration of app usage
timeFrame: Continuously throughout the study period (i.e., assessed every day during 12 months)
measure: LvL UP app: Actual usage of app components
timeFrame: Continuously throughout the study period (i.e., assessed every day during 12 months)
measure: LvL UP app: Coaching topic / sub-topic use
timeFrame: Continuously throughout the study period (i.e., assessed every day during 12 months)
measure: LvL UP app: Conversational turns
timeFrame: Continuously throughout the study period (i.e., assessed every day during 12 months)
measure: LvL UP app: Breeze (slow-paced breathing tool) usage
timeFrame: Continuously throughout the study period (i.e., assessed every day during 12 months)
measure: LvL UP app: Access to smartphone sensors (location - obfuscated)
timeFrame: Continuously throughout the study period (i.e., assessed every day during 12 months)
measure: LvL UP app: Access to smartphone sensors (location types)
timeFrame: Continuously throughout the study period (i.e., assessed every day during 12 months)
measure: LvL UP app: Access to smartphone sensors (raw gyroscope)
timeFrame: Continuously throughout the study period (i.e., assessed every day during 12 months)
measure: LvL UP app: Access to smartphone sensors (raw accelerometer)
timeFrame: Continuously throughout the study period (i.e., assessed every day during 12 months)
measure: Process evaluation (intervention group participants only): Net promoter score
timeFrame: Month 1, month 3, month 6
measure: Process evaluation (intervention group participants only): Self-Report Behavioral Automaticity Index
timeFrame: Baseline, month 1, month 3, month 6, month 12
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
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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.