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Body Electric: a Pragmatic Trial Evaluating the Viability of Movement Breaks

Body Electric: a Pragmatic Trial Evaluating Movement Breaks As a Public Health Strategy to Mitigate the Harms of Prolonged Sedentary Behavior

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06592209
Enrollment
20217
Registered
2024-09-19
Start date
2023-10-03
Completion date
2023-11-09
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sedentary Behavior

Keywords

Sedentary Behavior, Fatigue, Mood, Work Performance, Work Engagement, Implementation, Barriers, Intervention, Movement Breaks, Facilitators

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, race/ethnicity, employment status, employment setting, and occupation). Researchers will compare differences in the primary (implementation metrics), secondary (mood, fatigue, and work performance), and exploratory (barriers/facilitators) 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, barriers/facilitators, and mood/fatigue/work performance. * Complete a survey battery at the end of the study to report implementation potential, rank/rate barriers and facilitators, and evaluate mood/fatigue/work performance. To address the study aims, the investigator will recruit 50,000 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 barriers/facilitators will be assessed via survey at enrollment, as well as via daily surveys during the baseline and intervention monitoring periods.

Detailed description

U.S. adults spend on average \ 11-12 h/day 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 (e.g., 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 investigator's 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 (i.e., 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 (i.e., 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, race/ethnicity, 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 barriers/facilitators 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.

Interventions

Participants recruited through a podcast series (Body Electric) produced by National Public Radio were asked to select one of three movement break conditions (5 minutes of movement for every 30-, 60-, or 120-minutes of sedentary time). Participants are asked to complete movement breaks during all waking hours on weekdays and weekends (i.e. 7 days a week). During movement breaks, participants are instructed to walk for 5 minutes in whichever way was most comfortable and safe (i.e. self-selected pace and location). Participants who use an assistive device such as a wheelchair or walker, were instructed to wheel, walk, or complete other convenient, comfortable, and safe types of movement such as upper body exercises with resistance bands, chair-based exercises, etc. No break reminders were provided, although participants were encouraged to set reminders in their phones or to utilize commercially available apps or wearable devices.

Sponsors

Columbia University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Three-arm trial wherein participants self-selected a movement break dose to follow (5 min movement breaks every 30, 60, or 120 min)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 18 years of age or older * English speaking * Access to a smart phone with a data and text messaging plan

Exclusion criteria

* Recent history of bone, joint, or soft tissue injury that would be worsened by exercise * Chest pain at rest, during activities of daily living, or with movement * Instructions from a physician requiring supervised exercise

Design outcomes

Primary

MeasureTime frameDescription
Acceptability of Intervention Measure (AIM) Score2 weeksAcceptability - Measured by the Acceptability of Intervention Measure (AIM) instrument. The AIM is a 4-item survey that measures the extent to which a new treatment, or an intervention, is agreeable, palatable, or satisfactory. This is assessed at study completion via an end-of-study survey. Items are rated on a 5-point Likert scale from completely disagree to completely agree. Higher scores reflect higher acceptability of the intervention.
Number of Movement Breaks2 weeksThis is to measure compliance to the movement break condition. Completion of movement breaks is assessed using surveys either delivered via SMS 5 times per day or via one end of day survey (survey delivery method determined randomly). Participants self-report the number and duration of sedentary breaks completed since the last survey.
Intervention Appropriateness Measures (IAM) Score2 weeksAppropriateness - Measured by the Intervention Appropriateness Measures (IAM). The IAM is a 4-item survey that measures the perceived fit, relevance, or compatibility of a new treatment, or an intervention, for a given setting or consumer, and/or the perceived fit of the treatment/intervention to address a particular issue or problem. This is assessed at study completion via an end-of-study survey. Items are rated on a 5-point Likert scale from completely disagree to completely agree. Higher scores reflect higher appropriateness of the intervention.
Feasibility of Intervention Measure (FIM) Score2 weeksFeasibility - Measured by the Feasibility of Intervention Measure (FIM) instrument. The FIM is a 4-item survey that measures the extent to which a new treatment, or an intervention, can be successfully used or carried out within a given setting. This is assessed at study completion via an end-of-study survey. Items are rated on a 5-point Likert scale from completely disagree to completely agree. Higher scores reflect higher feasibility of the intervention.

Secondary

MeasureTime frameDescription
Utrecht Work Engagement Scale (UWES-3) Score2 weeksWork engagement is assessed using a shortened-version of the Utrecht Work Engagement Scale (UWES-3). It is composed of three items wherein participants rate the extent to which they experienced feelings of energy, enthusiasm, and immersion during work on a 7-point scale from never to always. Higher scores reflect higher work engagement.
Affect Visual Analog Scale (VAS) Score2 weeksMomentary or daily affect is assessed with a single item (i.e., how do you feel right now? How did you feel today?) on a visual analogue scale (VAS) from -50 (anchor: very negative) to +50 (anchor: very positive). A slider that moves in 1-point increments is used to indicate responses. Single item affect VAS scores are assessed using surveys either delivered via SMS 5 times per day (momentary assessments) or via one end of day survey (daily assessment). Survey delivery method is determined randomly.
Work Performance Visual Analog Scale (VAS) Score2 weeksDaily work performance is assessed with a single item (how would you rate your overall job performance today?) on a visual analogue scale (VAS) from 0 (anchor: worst performance) to 10 (anchor: top performance). A slider that moves in 1-point increments is used to indicate responses.
Fatigue Visual Analog Scale (VAS) Score2 weeksMomentary or daily fatigued are assessed with a single item (i.e., How fatigued are you right now? How fatigued were you today?) on a visual analogue scale (VAS) from 0 (anchor: no fatigue at all) to 100 (anchor: extremely fatigued). A slider that moved in 1-point increments is used to indicate responses. Single item fatigue VAS scores are assessed using surveys either delivered via SMS 5 times per day (momentary assessments) or via one end of day survey (daily assessment). Survey delivery method is determined randomly.
Fatigue Symptom Inventory (FSI) Score2 weeksPhysical exhaustion and fatigue are assessed using the Fatigue Symptom Inventory-3 (FSI-3). The instrument consists of 3 exhaustion/fatigued-related items (Average fatigue, Fatigue interference with activity levels, Fatigue interference with enjoyment of life) with response options on a 10-point scale from 0 (Not at all fatigued/No interference) to 10 (As fatigued as I could be/Extreme interference). Responses are summed with higher scores indicating greater perceived physical exhaustion/fatigued.
Positive and Negative Affect Schedule (PANAS) Short Form Score2 weeksPositive and negative affect are measured using the Positive and Negative Affect Schedule (PANAS) Short Form. This instrument contains 10 items wherein participants respond to words (i.e., hostile, nervous, attentive, inspired) that describe different feelings and emotions and indicate the extent they felt this way on a 5-point Likert scale from very slightly or not at all to extremely. The positive and negative affect subscales are each scored with higher scores reflecting higher positive/negative affect.
Work Performance Score2 weeksPerceived work performance quantity and quality, along with an overall rating of work performance, are measured by the World Health Organization Health and Work Performance Questionnaire (HPQ). The HPQ includes two items that measure performance quantity (e.g., How often did you not work at times when you were supposed to be working;) and three items that measure performance quality on a 5-point Likert scale; along with an overall rating of work performance on a 0 to 10 scale. Higher scores reflect higher perceived work performance.

Other

MeasureTime frameDescription
Percentage of participants that experienced barriers to movement break completion2-week intervention periodThis measure assesses the challenges (barriers) that participants face that inhibit them from completing movement breaks. During the intervention period, barriers are assessed using surveys either delivered via SMS 5 times per day or via one end of day survey (survey delivery method determined randomly). Participants are asked to select from a list of 18 common barriers or report via open text response other barriers not listed that they faced since the last survey. During the end-of-study survey, participants also rate the extent to which they experienced each barrier on 5-point Likert scale and rank their top three barriers.
Percentage of participants that experienced facilitator to movement break completion2 weeksThis measure assesses the strategies (or facilitators) that participants used to help them complete movement break protocol. During the intervention period, facilitators are assessed using surveys either delivered via SMS 5 times per day or via one end of day survey (survey delivery method determined randomly). Participants are asked to select from a list of 11 common facilitators or report via open text response other facilitators not listed that helped them take a movement break since the last survey. During the end-of-study survey, participants are also asked to rate and rank facilitators. During the end-of-study survey, participants also rate the extent to which they utilized each facilitator on 5-point Likert scale and rank their top three facilitators.
Sedentary Time2 weeksSedentary time is assessed using the Sedentary Behavior Questionnaire (SBQ). The SBQ assesses the amount of time spent doing 9 sedentary behaviors (watching television, playing computer/video games, sitting while listening to music, sitting and talking on the phone, doing paperwork or office work, sitting and reading, playing a musical instrument, doing arts and crafts, sitting and driving/riding in a car, bus, or train). The 9 items are completed separately for weekdays and weekend days. The time reported for each item are summed to derive daily sedentary time values expressed in minutes per day.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026