Energy BalanceNCT05911490
Effects of Breaking Sitting on Human Behaviour and Metabolic Health
A study testing Prolonged sitting and Breaking prolonged sitting in people with Energy Balance and Physical Activity Level, run by National Taiwan Normal University at 1 site in Taiwan.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Energy Balance, Physical Activity Level, Cognition
- What is being tested?
- Prolonged sitting and Breaking prolonged sitting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Dec 2019to 29 Sep 2020
- 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Smokers, post-menopausal female, and volunteers who used any medications that could influence metabolic and inflammatory responses.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Energy Balance, Physical Activity Level, Cognition, Metabolic Health
- Being tested
- Prolonged sitting, Breaking prolonged sitting
- Keywords
- Breaking up sitting, Eating behaviour, Spontaneous physical activity, Executive function, Energy balance
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolonged sittingBehavioural
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.
Breaking prolonged sittingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Prolonged sitting | Active comparator | Participants sat on a chair during the trial in the laboratory. Receives: Behavioral: Prolonged sitting |
| Breaking prolonged sitting | Experimental | Participants walked regularly during the trial in the laboratory. Receives: Behavioral: Breaking prolonged sitting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity level
Changes in physical activity level (steps) in the free-living conditions
Measured: 480 minutes
Energy intake
Changes in energy intake (kcal) in the free-living conditions
Measured: 480 minutes
Cognitive performance
Changes in cognitive performance (% changes in accuracy) including Task Switching and Flanker tasks
Measured: 320 minutes
Cognitive function
Changes in cognitive performance (% changes in reaction time) Task Switching and Flanker tasks
Measured: 320 minutes
Secondary outcomes (4)
Postprandial glucose concentrations
Changes in postprandial finger pricking glucose concentrations
Measured: 320 minutes
Blood pressure
Changes in systolic blood pressure and diastolic blood pressure
Measured: 320 minutes
Visual analogue scale (VAS)
Changes in self-perceived sensations including appetite, energy and mood (score from 0-100)
Measured: 320 minutes
Continuous glucose monitoring
Changes in different depots of adipose tissue interstitial glucose concentrations
Measured: 320 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start20 Dec 2019
- Primary completion29 Sep 2020
- Study completion29 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Energy BalanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan Normal University
- Sponsor type
- University, hospital or other
- Collaborators
- Division of Endocrinology and Metabolism, Tri-Service General Hospital
- Responsible party
- Principal investigator, Yung-Chih Chen, National Taiwan Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05911490
- Sponsor's protocol ID
- 2-108-05-151
- Status last verified
- Jun 2023
- First submitted
- 20 May 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Breaking Prolonged Sitting on 24-h Human Behaviours, Self-feelings, Metabolic Health and Cognition in Healthy Adults
- ClinicalTrials.gov ID
- NCT05911490
- Acronym / sponsor ID
- 2-108-05-151
- Conditions
- Energy Balance, Physical Activity Level, Cognition, Metabolic Health
- Keywords
- Breaking up sitting, Eating behaviour, Spontaneous physical activity, Executive function, Energy balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- National Taiwan Normal UniversityUniversity, hospital or other
- Collaborators
- Division of Endocrinology and Metabolism, Tri-Service General Hospital
- Study start
- 20 Dec 2019 (actual)
- Primary completion
- 29 Sep 2020 (actual)
- Study completion
- 29 Sep 2020 (actual)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prolonged sitting | Active comparator | Behavioral: Prolonged sittingParticipants sat on a chair during the trial in the laboratory. |
| Breaking prolonged sitting | Experimental | Behavioral: Breaking prolonged sittingParticipants walked regularly during the trial in the laboratory. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Smokers, post-menopausal female, and volunteers who used any medications that could influence metabolic and inflammatory responses.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prolonged sittingIn 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. | Behavioural | Prolonged sitting |
| Breaking prolonged sittingIn 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. | Behavioural | Breaking prolonged sitting |
Primary outcome
Physical activity level
Time frame: 480 minutes
Changes in physical activity level (steps) in the free-living conditions
Energy intake
Time frame: 480 minutes
Changes in energy intake (kcal) in the free-living conditions
Cognitive performance
Time frame: 320 minutes
Changes in cognitive performance (% changes in accuracy) including Task Switching and Flanker tasks
Cognitive function
Time frame: 320 minutes
Changes in cognitive performance (% changes in reaction time) Task Switching and Flanker tasks
4 secondary outcomes
Postprandial glucose concentrations
Time frame: 320 minutes
Blood pressure
Time frame: 320 minutes
Visual analogue scale (VAS)
Time frame: 320 minutes
Continuous glucose monitoring
Time frame: 320 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prolonged sitting and Breaking prolonged sitting in people with Energy Balance and Physical Activity Level, run by National Taiwan Normal University at 1 site in Taiwan.
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 4 inclusion and 1 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 22 Jun 2023. 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 Taiwan. 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?
Physical activity level (time frame: 480 minutes). 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?
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 22 Jun 2023.