NCT06592209

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

Completed NA Last updated 19 September 2024

What this trial tests

NA trial testing Sedentary Breaks in Sedentary Behavior in 20,217 participants. Completed in 9 November 2023.

Timeline

3 October 2023

Primary endpoint
9 November 2023

9 November 2023

Quick facts

Lead sponsor	Columbia University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	20,217
Start date	3 October 2023
Primary completion	9 November 2023
Estimated completion	9 November 2023
Sites	1 location across United States

Drugs / interventions tested

• Sedentary Breaks

Conditions studied

• Sedentary Behavior — all drugs for Sedentary Behavior →

Sponsor

Columbia University

Who can join

18 and older, any sex, with Sedentary Behavior. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.