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

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.

Study Overview

• Status: Completed
• Conditions: Sedentary Behavior
• Intervention / Treatment: Behavioral: Sedentary Breaks

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.

• Study Type: Interventional
• Enrollment (Actual): 20217
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10033
      • Columbia University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Every 30 Minutes Movement Break; Participants 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.	Behavioral: Sedentary 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.; Other Names: Movement Breaks
Experimental: Every 60 Minutes Movement Break; Participants 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.	Behavioral: Sedentary 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.; Other Names: Movement Breaks
Experimental: Every 120 Minutes Movement Break; Participants 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.	Behavioral: Sedentary 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.; Other Names: Movement Breaks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 weeks
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.	2 weeks
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.	2 weeks
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.	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 weeks
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.	2 weeks
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.	2 weeks
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.	2 weeks
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.	2 weeks
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.	2 weeks
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.	2 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants that experienced barriers to movement break completion	This 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.	2-week intervention period
Sedentary Time	Sedentary 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.	2 weeks
Percentage of participants that experienced facilitator to movement break completion	This 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.	2 weeks

Collaborators and Investigators

• Sponsor: Columbia University
• Investigators: Principal Investigator: Keith M Diaz, PhD, Florence Irving Associate Professor of Behavioral Medicine

Publications and helpful links

General Publications

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Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2023
• Primary Completion (Actual): November 9, 2023
• Study Completion (Actual): November 9, 2023

Study Registration Dates

• First Submitted: September 3, 2024
• First Submitted That Met QC Criteria: September 6, 2024
• First Posted (Estimated): September 12, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 11, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Implementation; Fatigue; Sedentary Behavior; Intervention; Barriers; Mood; Work Engagement; Work Performance; Facilitators; Movement Breaks
• Other Study ID Numbers: AAAU8061

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No