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Sedentary BehaviorNCT06592209

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

A study testing Sedentary Breaks in people with Sedentary Behavior, run by Columbia University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Sedentary Behavior
What is being tested?
Sedentary Breaks
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20,217 participants
Where
1 siteUnited States
Study dates
3 Oct 2023to 9 Nov 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Columbia University Medical Center

    New York, New York, 10033

Other trials in United States

About this study

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

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).
Read more

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.

Read the 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.

Being tested
Sedentary Breaks
Keywords
Sedentary Behavior, Fatigue, Mood, Work Performance, Work Engagement, Implementation, Barriers, Intervention, Movement Breaks, Facilitators
Medical subject headings
Sedentary Behavior, Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sedentary BreaksBehavioural

    Also called Movement Breaks

    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.

Study groups in NCT06592209
Study groupRoleWhat they receive
Every 30 Minutes Movement BreakExperimentalParticipants in the movement breaks every 30 minutes group complete a 7-day baseline period, followed by 2 weeks of the selected dose condition. Participants are asked to complete movement breaks every 30 minutes during all waking hours on weekdays and weekends (i.e. 7 days a week). Information regarding work productivity, energy and fatigue levels, mood, physical activity, and barriers/facilitators to taking movement breaks are collected via either 5 daily SMS surveys throughout the day (9am, 12pm, 3pm, 6pm, 9pm) or one emailed survey at the end of each day (8pm). Survey delivery method is randomized. Participants also provide feedback regarding the feasibility, acceptability, and appropriateness of the intervention.
Receives: Behavioral: Sedentary Breaks
Every 60 Minutes Movement BreakExperimentalParticipants in the movement breaks every 60 minutes group complete a 7-day baseline period, followed by 2 weeks of the selected dose condition. Participants are asked to complete movement breaks every 60 minutes during all waking hours on weekdays and weekends (i.e. 7 days a week). Information regarding work productivity, energy and fatigue levels, mood, physical activity, and barriers/facilitators to taking movement breaks are collected via either 5 daily SMS surveys throughout the day (9am, 12pm, 3pm, 6pm, 9pm) or one emailed survey at the end of each day (8pm). Survey delivery method is randomized. Participants also provide feedback regarding the feasibility, acceptability, and appropriateness of the intervention.
Receives: Behavioral: Sedentary Breaks
Every 120 Minutes Movement BreakExperimentalParticipants in the movement breaks every 120 minutes group complete a 7-day baseline period, followed by 2 weeks of the selected dose condition. Participants are asked to complete movement breaks every 120 minutes during all waking hours on weekdays and weekends (i.e. 7 days a week). Information regarding work productivity, energy and fatigue levels, mood, physical activity, and barriers/facilitators to taking movement breaks are collected via either 5 daily SMS surveys throughout the day (9am, 12pm, 3pm, 6pm, 9pm) or one emailed survey at the end of each day (8pm). Survey delivery method is randomized. Participants also provide feedback regarding the feasibility, acceptability, and appropriateness of the intervention.
Receives: Behavioral: Sedentary Breaks

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of Intervention Measure (FIM) Score

    Feasibility - 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.

    Measured: 2 weeks

  2. Acceptability of Intervention Measure (AIM) Score

    Acceptability - 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.

    Measured: 2 weeks

  3. Intervention Appropriateness Measures (IAM) Score

    Appropriateness - 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.

    Measured: 2 weeks

  4. Number of Movement Breaks

    This 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.

    Measured: 2 weeks

Secondary outcomes (7)

  1. Fatigue Symptom Inventory (FSI) Score

    Physical 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.

    Measured: 2 weeks

  2. Positive and Negative Affect Schedule (PANAS) Short Form Score

    Positive 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.

    Measured: 2 weeks

  3. Work Performance Score

    Perceived 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.

    Measured: 2 weeks

  4. Utrecht Work Engagement Scale (UWES-3) Score

    Work 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.

    Measured: 2 weeks

  5. Fatigue Visual Analog Scale (VAS) Score

    Momentary 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.

    Measured: 2 weeks

  6. Affect Visual Analog Scale (VAS) Score

    Momentary 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.

    Measured: 2 weeks

  7. Work Performance Visual Analog Scale (VAS) Score

    Daily 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.

    Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start3 Oct 2023
  3. Primary completion9 Nov 2023
  4. Study completion9 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
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)
Masking
None (open label)
Enrolment
20,217 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06592209
Sponsor's protocol ID
AAAU8061
Status last verified
Sep 2024
First submitted
3 Sep 2024
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Archer E, Shook RP, Thomas DM, Church TS, Katzmarzyk PT, Hebert JR, McIver KL, Hand GA, Lavie CJ, Blair SN. 45-Year trends in women's use of time and household management energy expenditure. PLoS One. 2013;8(2):e56620. doi: 10.1371/journal.pone.0056620. Epub 2013 Feb 20.

    PubMed 23437187

  • Church TS, Earnest CP, Skinner JS, Blair SN. Effects of different doses of physical activity on cardiorespiratory fitness among sedentary, overweight or obese postmenopausal women with elevated blood pressure: a randomized controlled trial. JAMA. 2007 May 16;297(19):2081-91. doi: 10.1001/jama.297.19.2081.

    PubMed 17507344

  • van der Ploeg HP, Venugopal K, Chau JY, van Poppel MNM, Breedveld K, Merom D, Bauman AE. Non-occupational sedentary behaviors: population changes in The Netherlands, 1975-2005. Am J Prev Med. 2013 Apr;44(4):382-387. doi: 10.1016/j.amepre.2012.11.034.

    PubMed 23498104

  • Dunstan DW, Howard B, Healy GN, Owen N. Too much sitting--a health hazard. Diabetes Res Clin Pract. 2012 Sep;97(3):368-76. doi: 10.1016/j.diabres.2012.05.020. Epub 2012 Jun 9.

    PubMed 22682948

  • Brownson RC, Boehmer TK, Luke DA. Declining rates of physical activity in the United States: what are the contributors? Annu Rev Public Health. 2005;26:421-43. doi: 10.1146/annurev.publhealth.26.021304.144437.

    PubMed 15760296

  • Diaz KM, Howard VJ, Hutto B, Colabianchi N, Vena JE, Blair SN, Hooker SP. Patterns of Sedentary Behavior in US Middle-Age and Older Adults: The REGARDS Study. Med Sci Sports Exerc. 2016 Mar;48(3):430-8. doi: 10.1249/MSS.0000000000000792.

    PubMed 26460633

  • Biswas A, Oh PI, Faulkner GE, Bajaj RR, Silver MA, Mitchell MS, Alter DA. Sedentary time and its association with risk for disease incidence, mortality, and hospitalization in adults: a systematic review and meta-analysis. Ann Intern Med. 2015 Jan 20;162(2):123-32. doi: 10.7326/M14-1651.

    PubMed 25599350

  • Diaz KM, Howard VJ, Hutto B, Colabianchi N, Vena JE, Safford MM, Blair SN, Hooker SP. Patterns of Sedentary Behavior and Mortality in U.S. Middle-Aged and Older Adults: A National Cohort Study. Ann Intern Med. 2017 Oct 3;167(7):465-475. doi: 10.7326/M17-0212. Epub 2017 Sep 12.

    PubMed 28892811

  • Thorp AA, Owen N, Neuhaus M, Dunstan DW. Sedentary behaviors and subsequent health outcomes in adults a systematic review of longitudinal studies, 1996-2011. Am J Prev Med. 2011 Aug;41(2):207-15. doi: 10.1016/j.amepre.2011.05.004.

    PubMed 21767729

  • Wilmot EG, Edwardson CL, Achana FA, Davies MJ, Gorely T, Gray LJ, Khunti K, Yates T, Biddle SJ. Sedentary time in adults and the association with diabetes, cardiovascular disease and death: systematic review and meta-analysis. Diabetologia. 2012 Nov;55(11):2895-905. doi: 10.1007/s00125-012-2677-z. Epub 2012 Aug 14.

    PubMed 22890825

  • Ekelund U, Tarp J, Steene-Johannessen J, Hansen BH, Jefferis B, Fagerland MW, Whincup P, Diaz KM, Hooker SP, Chernofsky A, Larson MG, Spartano N, Vasan RS, Dohrn IM, Hagstromer M, Edwardson C, Yates T, Shiroma E, Anderssen SA, Lee IM. Dose-response associations between accelerometry measured physical activity and sedentary time and all cause mortality: systematic review and harmonised meta-analysis. BMJ. 2019 Aug 21;366:l4570. doi: 10.1136/bmj.l4570.

    PubMed 31434697

  • Patterson R, McNamara E, Tainio M, de Sa TH, Smith AD, Sharp SJ, Edwards P, Woodcock J, Brage S, Wijndaele K. Sedentary behaviour and risk of all-cause, cardiovascular and cancer mortality, and incident type 2 diabetes: a systematic review and dose response meta-analysis. Eur J Epidemiol. 2018 Sep;33(9):811-829. doi: 10.1007/s10654-018-0380-1. Epub 2018 Mar 28.

    PubMed 29589226

  • Young DR, Hivert MF, Alhassan S, Camhi SM, Ferguson JF, Katzmarzyk PT, Lewis CE, Owen N, Perry CK, Siddique J, Yong CM; Physical Activity Committee of the Council on Lifestyle and Cardiometabolic Health; Council on Clinical Cardiology; Council on Epidemiology and Prevention; Council on Functional Genomics and Translational Biology; and Stroke Council. Sedentary Behavior and Cardiovascular Morbidity and Mortality: A Science Advisory From the American Heart Association. Circulation. 2016 Sep 27;134(13):e262-79. doi: 10.1161/CIR.0000000000000440. Epub 2016 Aug 15.

    PubMed 27528691

  • Heron L, O'Neill C, McAneney H, Kee F, Tully MA. Direct healthcare costs of sedentary behaviour in the UK. J Epidemiol Community Health. 2019 Jul;73(7):625-629. doi: 10.1136/jech-2018-211758. Epub 2019 Mar 25.

    PubMed 30910857

  • Katzmarzyk PT, Powell KE, Jakicic JM, Troiano RP, Piercy K, Tennant B; 2018 PHYSICAL ACTIVITY GUIDELINES ADVISORY COMMITTEE*. Sedentary Behavior and Health: Update from the 2018 Physical Activity Guidelines Advisory Committee. Med Sci Sports Exerc. 2019 Jun;51(6):1227-1241. doi: 10.1249/MSS.0000000000001935.

    PubMed 31095080

Questions about this trial

What is this clinical trial studying?

A study testing Sedentary Breaks in people with Sedentary Behavior, run by Columbia University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of Intervention Measure (FIM) Score (time frame: 2 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06592209, which also lists 181 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

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