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临床试验/NCT06592209
NCT06592209已完成不适用

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

Columbia University2 个研究点 分布在 1 个国家目标入组 20,217 人开始时间: 2023年10月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20,217
试验地点
2
主要终点
Feasibility of Intervention Measure (FIM) Score

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Feasibility of Intervention Measure (FIM) Score

时间窗: 2 weeks

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.

Acceptability of Intervention Measure (AIM) Score

时间窗: 2 weeks

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.

Intervention Appropriateness Measures (IAM) Score

时间窗: 2 weeks

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.

Number of Movement Breaks

时间窗: 2 weeks

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.

次要结局

  • Fatigue Symptom Inventory (FSI) Score(2 weeks)
  • Positive and Negative Affect Schedule (PANAS) Short Form Score(2 weeks)
  • Work Performance Score(2 weeks)
  • Utrecht Work Engagement Scale (UWES-3) Score(2 weeks)
  • Fatigue Visual Analog Scale (VAS) Score(2 weeks)
  • Affect Visual Analog Scale (VAS) Score(2 weeks)
  • Work Performance Visual Analog Scale (VAS) Score(2 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Keith Diaz

Associate Professor of Behavioral Medicine

Columbia University

研究点 (2)

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