Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06360029
Status:
COMPLETED
Last Update Posted:
2024-04-17
First Post:
2024-04-01
Brief Title:
The LvL UP Pilot Trial
Sponsor:
Singapore ETH Centre
Organization:
Singapore ETH Centre
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 interventions preliminary short-term effects What is the interventions level of engagement What is the number of dropouts What is the percentage of missing data What is the interventions 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 andor trial assessments online and in-person
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 interventions preliminary short-term effects What is the interventions level of engagement What is the number of dropouts What is the percentage of missing data What is the interventions 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 andor 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 Singapores Health Promotion Board
Participants will be randomly allocated to groups 1 or 2 LvL UP or comparison following a 21 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 11 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 Councils 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 eg sociodemographic variables personality ii identify the most cost-effective intervention condition from the societal perspective eg self-reported sickness absence and iii investigate which LvL UP app and smartphone sensor data eg usage patterns location might be effective in predicting participants 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 ie the margin of error as a proportion of the outcomes 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
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 Singapores Health Promotion Board
Participants will be randomly allocated to groups 1 or 2 LvL UP or comparison following a 21 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 11 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 Councils 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 eg sociodemographic variables personality ii identify the most cost-effective intervention condition from the societal perspective eg self-reported sickness absence and iii investigate which LvL UP app and smartphone sensor data eg usage patterns location might be effective in predicting participants 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 ie the margin of error as a proportion of the outcomes 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None