Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06592443
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-09
Brief Title:
The LvL UP Trial Assessing the Effectiveness of a MHealth Intervention
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The LvL UP Trial a Sequential Multiple Assignment Randomized Controlled 2 Trial to Assess the Effectiveness of a Blended Mobile Lifestyle Intervention
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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
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
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
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 21 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 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 The LvL UP pilot study results NCT06360029 will be used to inform the tailoring variables for the trial ie to define response non-response at month 1 Engagement and app evaluation variables eg number of app components completed over the first 4 weeks net promoter score preliminary intervention effects eg 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 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 all relevant measures are described in the outcomes section
A To identify the most cost-effective intervention condition from the societal perspective eg self-reported sickness absence
B To explore time-varying and baseline moderators on intervention outcomes eg sociodemographic variables personality
C To investigate behavior maintenance by assessing the intervention outcomes at six months of follow-up ie 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 eg audio signals usage patterns are most useful for predicting the presence of subclinical depression anxiety stress andor 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 AB and the comparison condition and between LvL UP adaptive MI AC versus the comparison condition primary objective For both comparisons we assume the effect size Cohens d for well-being to be 03 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 participants 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 Jabir et al 2023 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 1073 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
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 21 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 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 The LvL UP pilot study results NCT06360029 will be used to inform the tailoring variables for the trial ie to define response non-response at month 1 Engagement and app evaluation variables eg number of app components completed over the first 4 weeks net promoter score preliminary intervention effects eg 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 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 all relevant measures are described in the outcomes section
A To identify the most cost-effective intervention condition from the societal perspective eg self-reported sickness absence
B To explore time-varying and baseline moderators on intervention outcomes eg sociodemographic variables personality
C To investigate behavior maintenance by assessing the intervention outcomes at six months of follow-up ie 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 eg audio signals usage patterns are most useful for predicting the presence of subclinical depression anxiety stress andor 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 AB and the comparison condition and between LvL UP adaptive MI AC versus the comparison condition primary objective For both comparisons we assume the effect size Cohens d for well-being to be 03 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 participants 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 Jabir et al 2023 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 1073 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None