- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05911490
Effects of Breaking Sitting on Human Behaviour and Metabolic Health
June 9, 2023 updated by: Yung-Chih Chen, National Taiwan Normal University
Effects of Breaking Prolonged Sitting on 24-h Human Behaviours, Self-feelings, Metabolic Health and Cognition in Healthy Adults
This study primarily aimed to investigate effects of breaking up prolonged sitting with intermittent brisk walking in healthy young individuals on (1) post-trial human behaviours including energy intake and physical activity under free-living conditions and (2) cognitive performance in a simulated workplace environment.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Taipei, Taiwan
- National Taiwan Normal University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Without current and any history of brain injury, neurological disorder, cardiometabolic related diseases, diabetes or cancers.
- Weight stable (not self-reported weight change ± 3 kg at least 3 months)
- Body mass index (BMI) ranging between 18.5 to 27 kg/m2
- Can walk safely on a treadmill
Exclusion Criteria:
- Smokers, post-menopausal female, and volunteers who used any medications that could influence metabolic and inflammatory responses.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Prolonged sitting
Participants sat on a chair during the trial in the laboratory.
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In the laboratory, after consuming 1st meal, participants sat on a chair for 180 min.
After 180 min, the 2nd meal was provided.
After finishing the 2nd meal, participants sat on a chair for another 120 min.
After data collection was completed in the laboratory, participants were asked to keep wearing the same pedometer and to record any food and liquid consumption for the rest of the day (until midnight) under free-living conditions.
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Experimental: Breaking prolonged sitting
Participants walked regularly during the trial in the laboratory.
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In the laboratory, after consuming 1st meal, participants walked 2 min on a treadmill every 20 minutes for the following 180 min.
For the remainder of the time participants sat on the chair.
After 180 min, the 2nd meal was provided.
After finishing the 2nd meal, participants continued 2 min of walking every 20 min for the following 120 min.
After data collection was completed in the laboratory, participants were asked to keep wearing the same pedometer and to record any food and liquid consumption for the rest of the day (until midnight) under free-living conditions.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Physical activity level
Time Frame: 480 minutes
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Changes in physical activity level (steps) in the free-living conditions
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480 minutes
|
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Energy intake
Time Frame: 480 minutes
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Changes in energy intake (kcal) in the free-living conditions
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480 minutes
|
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Cognitive performance
Time Frame: 320 minutes
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Changes in cognitive performance (% changes in accuracy) including Task Switching and Flanker tasks
|
320 minutes
|
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Cognitive function
Time Frame: 320 minutes
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Changes in cognitive performance (% changes in reaction time) Task Switching and Flanker tasks
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320 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postprandial glucose concentrations
Time Frame: 320 minutes
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Changes in postprandial finger pricking glucose concentrations
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320 minutes
|
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Blood pressure
Time Frame: 320 minutes
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Changes in systolic blood pressure and diastolic blood pressure
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320 minutes
|
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Visual analogue scale (VAS)
Time Frame: 320 minutes
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Changes in self-perceived sensations including appetite, energy and mood (score from 0-100)
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320 minutes
|
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Continuous glucose monitoring
Time Frame: 320 minutes
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Changes in different depots of adipose tissue interstitial glucose concentrations
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320 minutes
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 20, 2019
Primary Completion (Actual)
September 29, 2020
Study Completion (Actual)
September 29, 2020
Study Registration Dates
First Submitted
May 20, 2023
First Submitted That Met QC Criteria
June 9, 2023
First Posted (Actual)
June 22, 2023
Study Record Updates
Last Update Posted (Actual)
June 22, 2023
Last Update Submitted That Met QC Criteria
June 9, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2-108-05-151
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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