Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06592209
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-03
Brief Title:
Body Electric a Pragmatic Trial Evaluating the Viability of Movement Breaks
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Body Electric a Pragmatic Trial Evaluating Movement Breaks As a Public Health Strategy to Mitigate the Harms of Prolonged Sedentary Behavior
Status:
COMPLETED
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:
The purpose of this pragmatic trial is to determine the implementation potential of three movement break doses every 30 60 or 90 min under real-world conditions The main questions it aims to answer are
What is the feasibility acceptability appropriateness and compliance to the tested movement break doses under real-world conditions
What is the effectiveness of the movement break doses on improving mood fatigue and work performance
What are the barriers of and facilitators to taking movement breaks across population subgroups age group sex raceethnicity employment status employment setting and occupation
Researchers will compare differences in the primary implementation metrics secondary mood fatigue and work performance and exploratory barriersfacilitators outcomes across the three trial arms movement breaks every 30 60 or 120 minutes
Participants will
Take movement breaks 5 minutes of walking at a self-selected pace daily according to their dose condition every 30 60 or 90 minutes for two consecutive weeks
Complete daily surveys to report compliance barriersfacilitators and moodfatiguework performance
Complete a survey battery at the end of the study to report implementation potential rankrate barriers and facilitators and evaluate moodfatiguework performance
To address the study aims the investigator will recruit 50000 adults and will conduct a dosing study that concurrently tests three movement break doses Participants will complete a 7-day baseline period to assess normal durations of sedentary behavior and movement followed by a 2-week period during which they will be select a movement break dose to implement in their everyday life for the duration of the program The break frequency x duration combination will include 5 minute every 30 minutes 5 minutes every 60 minutes and 5 minutes every 120 minutes Work and leisure behaviors mood fatigue and barriersfacilitators will be assessed via survey at enrollment as well as via daily surveys during the baseline and intervention monitoring periods
What is the feasibility acceptability appropriateness and compliance to the tested movement break doses under real-world conditions
What is the effectiveness of the movement break doses on improving mood fatigue and work performance
What are the barriers of and facilitators to taking movement breaks across population subgroups age group sex raceethnicity employment status employment setting and occupation
Researchers will compare differences in the primary implementation metrics secondary mood fatigue and work performance and exploratory barriersfacilitators outcomes across the three trial arms movement breaks every 30 60 or 120 minutes
Participants will
Take movement breaks 5 minutes of walking at a self-selected pace daily according to their dose condition every 30 60 or 90 minutes for two consecutive weeks
Complete daily surveys to report compliance barriersfacilitators and moodfatiguework performance
Complete a survey battery at the end of the study to report implementation potential rankrate barriers and facilitators and evaluate moodfatiguework performance
To address the study aims the investigator will recruit 50000 adults and will conduct a dosing study that concurrently tests three movement break doses Participants will complete a 7-day baseline period to assess normal durations of sedentary behavior and movement followed by a 2-week period during which they will be select a movement break dose to implement in their everyday life for the duration of the program The break frequency x duration combination will include 5 minute every 30 minutes 5 minutes every 60 minutes and 5 minutes every 120 minutes Work and leisure behaviors mood fatigue and barriersfacilitators will be assessed via survey at enrollment as well as via daily surveys during the baseline and intervention monitoring periods
Detailed Description:
US adults spend on average 11-12 hday sedentary Accordingly the phrase sitting is the new smoking has been used to describe an epidemic of developed nations Daily sedentary time is strongly associated with risk for cardiovascular disease CVD morbidity and mortality irrespective of moderate-vigorous physical activity MVPA As such the 2018 Physical Activity Guidelines for Americans have expanded beyond promoting MVPA and now also advocate for reductions in sedentary time These recommendations however are very general sit less move more due to a paucity of data to inform more quantitative recommendations To inform more specific guidelines both the 2018 Physical Activity Guidelines Advisory Committee Scientific Report and a scientific advisory on sedentary behavior from the American Heart Association AHA have identified a critical research need for studies that compare different doses of reducing sedentary time on health outcomes and evaluate the barriers to real-world implementation of sedentary time reduction strategies Such studies were deemed to be critical for development of evidence based sedentary behavior guidelines The proposed study will address this major evidence gap and provide evidence to inform the feasibility of specific quantitative movement break sedentary behavior recommendations
Research has implicated sedentary time accrued in prolonged uninterrupted bouts eg sitting for hours at a time as potentially the most hazardous form of sedentary behavior suggestive that regularly breaking up sedentary time with bouts of activity may be an important adjunct to existing physical activity guidelines Although these data inform which sedentary behavior feature to target they provide little to inform quantitative guidelines Thus only general recommendations to sit less move more have been proposed without specific actionable targets The investigators latest laboratory-based research has documented quantitative guidance regarding 1 How frequent should periods of prolonged sedentary time be interrupted and 2 What is the appropriate duration of these breaks in sedentary time However it is unclear how feasible and acceptable these quantitative recommendations ie taking a walking break every half hour for 5 minutes are Moreover the barriers to and facilitators of successfully implementing breaks in sedentary time during the day are largely unknown
Primary Aim To determine the feasibility acceptability and appropriateness ie the implementation potential of and compliance to three movement break doses every 30 60 or 120 minutes under real world conditions
Secondary Aim To determine the effect of various movement break doses on mood fatigue and work performance
Exploratory Aim The successful implementation of movement breaks into mainstream society relies on an understanding of common facilitators and barriers to movement breaks faced by the public across a vast array of population subgroups This study will map barriers to and facilitators of movement breaks by age group young middle-aged and older adults sex raceethnicity employment status full-time part-time retired not working employment setting remote in-person hybrid and occupation type
Excessive sedentary time is highly prevalent in developed nations and linked to increased CVD risk No evidence-based recommendations exist on how people should break up sedentary time Evaluating the implementation potential of doses in frequency and duration of a movement break intervention that yields improvements across several health indices and establishing barriersfacilitators to movement breaks across population subgroups could have a powerful impact on public health by establishing a recommended movement break dose for future randomized trials and guidelines and laying the foundation to optimize future movement break interventions that address population barriers
Research has implicated sedentary time accrued in prolonged uninterrupted bouts eg sitting for hours at a time as potentially the most hazardous form of sedentary behavior suggestive that regularly breaking up sedentary time with bouts of activity may be an important adjunct to existing physical activity guidelines Although these data inform which sedentary behavior feature to target they provide little to inform quantitative guidelines Thus only general recommendations to sit less move more have been proposed without specific actionable targets The investigators latest laboratory-based research has documented quantitative guidance regarding 1 How frequent should periods of prolonged sedentary time be interrupted and 2 What is the appropriate duration of these breaks in sedentary time However it is unclear how feasible and acceptable these quantitative recommendations ie taking a walking break every half hour for 5 minutes are Moreover the barriers to and facilitators of successfully implementing breaks in sedentary time during the day are largely unknown
Primary Aim To determine the feasibility acceptability and appropriateness ie the implementation potential of and compliance to three movement break doses every 30 60 or 120 minutes under real world conditions
Secondary Aim To determine the effect of various movement break doses on mood fatigue and work performance
Exploratory Aim The successful implementation of movement breaks into mainstream society relies on an understanding of common facilitators and barriers to movement breaks faced by the public across a vast array of population subgroups This study will map barriers to and facilitators of movement breaks by age group young middle-aged and older adults sex raceethnicity employment status full-time part-time retired not working employment setting remote in-person hybrid and occupation type
Excessive sedentary time is highly prevalent in developed nations and linked to increased CVD risk No evidence-based recommendations exist on how people should break up sedentary time Evaluating the implementation potential of doses in frequency and duration of a movement break intervention that yields improvements across several health indices and establishing barriersfacilitators to movement breaks across population subgroups could have a powerful impact on public health by establishing a recommended movement break dose for future randomized trials and guidelines and laying the foundation to optimize future movement break interventions that address population barriers
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