ObesitySITLessNCT04926207
The Effects of Interrupting Prolonged Sitting With Bouts of Physical Activity on Neurocognitive Function in Obesity
A study testing Physical Activity Breaks Intervention in people with Obesity, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial summary
It is projected that by 2030 almost 50% of adults in the USA will have obesity. High sedentariness and physical inactivity contribute to the obesity pandemic. Neurocognitive deficits compound the global burden of obesity. Read more about this study
- Who is it for?
- Ages 21 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Physical Activity Breaks Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2021to 31 May 2024
- 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 21 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • Informed consent
- Age 21-64 years
- BMI within ≥ 30 and < 40 kg/m2 range
- Pre-menopausal
- Fasting plasma glucose (FPG) < 100 mg/dL
- Resting blood pressure: systolic < 160 mmHg or diastolic < 100 mmHg
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- Employed in sedentary occupation (i.e., participants reporting sitting on average 6 h/d on a weekday and with objectively assessed sitting time ≥ 8 h/day)
- Physically inactive (i.e., engaging in < 150 min of moderate or < 75 min of vigorous or any combination of the two intensities per week)
- Participants must have had no prior diagnosis of cognitive or physical disability (e.g., ADHD, severe asthma, epilepsy, chronic kidney disease, or dependence upon a wheelchair/walking aid)
- Free of medication that could affect cognitive function or metabolism
- Normal or corrected-to-normal vision based on the minimal 20/20 standard in order to complete the cognitive task (below 20/20 vision)
- Must be able to engage in vigorous exercise
- Fluency in English
Who cannot join
- • Impaired glucose tolerance defined as fasting plasma glucose (FPG) < 100 mg/dL
- Oral glucose tolerance test (OGTT) blood glucose values ≥ 200 mg/dL
- Participants with any psychiatric, neurological or metabolic disorder
- Participants who have or are currently taking the medication that could affect cognitive function, metabolism or weight status
- Participants with substance abuse
- Participants with a standardized score on the test of general cognitive abilities below 85
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- Participants with anemia
- Pregnant women or those with a possible pregnancy
- History of injury to the spinal cord
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Urbana-Champaign
Urbana, Illinois, 61801
About this study
Official title: SIT Less! Interrupting Prolonged Sitting With Brief Physical Activity Bouts to Improve Neurocognitive Function in Adults With Obesity
It is projected that by 2030 almost 50% of adults in the USA will have obesity. High sedentariness and physical inactivity contribute to the obesity pandemic. Neurocognitive deficits compound the global burden of obesity. Specifically, adults with obesity underperform on tasks of executive functioning, which underpin goal-directed behavior and have been linked to occupational success. Growing evidence suggests poorer executive functioning among more sedentary adults. Emergent studies have shown that accumulating sedentary time in prolonged bouts (e.g., remaining sedentary continuously 20 min or more) may decrease the ability to control distractions along with working memory. Interrupting prolonged sitting with brief bouts of physical activity is an effective strategy to improve postprandial glucose metabolism. However, the effects of this simple intervention on neural processes supporting executive functioning remain unknown. Accordingly, the aim of this study is to test the effects of interrupting prolonged sitting with frequent (every 30 min) but brief (3 min) physical activity bouts on inhibitory control, working memory, and their neuroelectric indices (N2, P3a, and P3b components of event-related brain potentials). Our secondary aim is to explore the potential mechanisms underlying the effects of interrupting prolonged sitting with physical activity on cognitive and brain function through glucose metabolism and insulin physiology. Findings from this study will help advance our understanding of how restructuring sedentary time may help improve cognitive and brain functions among adults with obesity.
Read the detailed description
Measurements of cognitive and brain function will be taken before, and after three hours of prolonged sitting. Metabolic, heart rate, and blood pressure measures, along with the ratings of fatigue will be collected before and during the three-hour prolonged sitting time. The prolonged sitting time will be either interrupted with physical activity breaks or with sedentary breaks (attention control). Habitual physical activity, sedentary behavior, sleep, and dietary intake will also be assessed.
- Conditions
- Obesity
- Being tested
- Physical Activity Breaks Intervention, Talking Breaks Control
- Keywords
- Sedentary Behavior, Executive Function, Event Related Potentials, Insulin, Glucose
- Medical subject headings
- Obesity, Sedentary Behavior, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Activity Breaks InterventionBehavioural
Participants will be asked to walk on a treadmill for 3 min at a moderate intensity (55% of heart rate reserve) at an increasing speed and incline to reach and maintain their target heart rate.
Talking Breaks ControlBehavioural
Every 30 min a researcher will start a brief conversation with a participant based on a pre-selected topic, which will change with each break. Topics are standardized across participants and include, for example, pollution, smart clothes, and hydration. A presentation will be followed by questions and answers. The break will last 3 min.
| Study group | Role | What they receive |
|---|---|---|
| Physical Activity Breaks Intervention | Experimental | Participants will sit continuously for 3 hours and interrupt their sitting by walking on a treadmill at a moderate intensity for 3 min. Receives: Behavioral: Physical Activity Breaks Intervention |
| Talking Breaks Control | Active comparator | Participants will sit continuously for 3 hours. They will interrupt solitary sitting activities (while remaining seated) by talking to a researcher for 3 min on pre-selected topics of general interest. Receives: Behavioral: Talking Breaks Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuroelectric measures of inhibitory control - P3 component of event-related potentials (ERPs)
The change in the P3 component measured during the modified flanker task
Measured: Assessed immediately before and after the intervention (on the same day as intervention)
Neuroelectric measures of inhibitory control - N2 component of event-related potentials (ERPs)
The change in the N2-ERP component measured during the modified flanker task.
Measured: Assessed immediately before and after the intervention (on the same day as intervention)
Inhibitory control measured with a modified flanker task - accuracy
The change in accuracy on the modified flanker task
Measured: Assessed immediately before and after the intervention (on the same day as intervention)
Inhibitory control measured with a modified flanker task - reaction time
The change in measures of reaction time on the modified flanker task
Measured: Assessed immediately before and after the intervention (on the same day as intervention)
Neuroelectric measures of working memory - P3-ERP component
The change in the P3-ERP component during the n-back task.
Measured: Assessed immediately before and after the intervention (on the same day as intervention)
Working memory measured with an n-back task - accuracy
The change in accuracy on the n-back task
Measured: Assessed immediately before and after the intervention (on the same day as intervention)
Working memory measured with an n-back task - reaction time
The change in measures of reaction time on the n-back task
Measured: Assessed immediately before and after the intervention (on the same day as intervention)
Secondary outcomes (4)
Post-prandial insulin response during an oral glucose tolerance test
Insulin Area Under the Curve (AUC)
Measured: Assessed during the intervention
Post-prandial glucose response during an oral glucose tolerance test
Glucose Area Under the Curve (AUC)
Measured: Assessed during the intervention
Matsuda index
Insulin Sensitivity measured with Matsuda index
Measured: Assessed during the intervention
Stumvoll metabolic clearance rate (MCR)
Insulin Sensitivity expressed as Stumvoll metabolic clearance rate
Measured: Assessed during the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2021
- Study start3 May 2021
- Primary completion31 May 2024 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dominika M Pindus, PhD, Principal investigator, University of Illinois at Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04926207
- Sponsor's protocol ID
- 20633
- Acronym
- SITLess
- Status last verified
- Feb 2024
- First submitted
- 24 May 2021
- Last updated
- 7 Feb 2024
- 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 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SIT Less! Interrupting Prolonged Sitting With Brief Physical Activity Bouts to Improve Neurocognitive Function in Adults With Obesity
- ClinicalTrials.gov ID
- NCT04926207
- Acronym / sponsor ID
- SITLess / 20633
- Conditions
- Obesity
- Keywords
- Sedentary Behavior, Executive Function, Event Related Potentials, Insulin, Glucose
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Study start
- 3 May 2021 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 15 Jun 2021 (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.
It is projected that by 2030 almost 50% of adults in the USA will have obesity. High sedentariness and physical inactivity contribute to the obesity pandemic. Neurocognitive deficits compound the global burden of obesity. Specifically, adults with obesity underperform on tasks of executive functioning, which underpin goal-directed behavior and have been linked to occupational success. Growing evidence suggests poorer executive functioning among more sedentary adults. Emergent studies have shown that accumulating sedentary time in prolonged bouts (e.g., remaining sedentary continuously 20 min or more) may decrease the ability to control distractions along with working memory. Interrupting prolonged sitting with brief bouts of physical activity is an effective strategy to improve postprandial glucose metabolism. However, the effects of this simple intervention on neural processes supporting executive functioning remain unknown. Accordingly, the aim of this study is to test the effects of interrupting prolonged sitting with frequent (every 30 min) but brief (3 min) physical activity bouts on inhibitory control, working memory, and their neuroelectric indices (N2, P3a, and P3b components of event-related brain potentials). Our secondary aim is to explore the potential mechanisms underlying the effects of interrupting prolonged sitting with physical activity on cognitive and brain function through glucose metabolism and insulin physiology. Findings from this study will help advance our understanding of how restructuring sedentary time may help improve cognitive and brain functions among adults with obesity.
Detailed description
Measurements of cognitive and brain function will be taken before, and after three hours of prolonged sitting. Metabolic, heart rate, and blood pressure measures, along with the ratings of fatigue will be collected before and during the three-hour prolonged sitting time. The prolonged sitting time will be either interrupted with physical activity breaks or with sedentary breaks (attention control). Habitual physical activity, sedentary behavior, sleep, and dietary intake will also be assessed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Activity Breaks Intervention | Experimental | Behavioral: Physical Activity Breaks InterventionParticipants will sit continuously for 3 hours and interrupt their sitting by walking on a treadmill at a moderate intensity for 3 min. |
| Talking Breaks Control | Active comparator | Behavioral: Talking Breaks ControlParticipants will sit continuously for 3 hours. They will interrupt solitary sitting activities (while remaining seated) by talking to a researcher for 3 min on pre-selected topics of general interest. |
Who may qualify
- Ages
- 21 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- • Informed consent
Key exclusion criteria (9 listed)
- • Impaired glucose tolerance defined as fasting plasma glucose (FPG) < 100 mg/dL
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 |
|---|---|---|
| Physical Activity Breaks InterventionParticipants will be asked to walk on a treadmill for 3 min at a moderate intensity (55% of heart rate reserve) at an increasing speed and incline to reach and maintain their target heart rate. | Behavioural | Physical Activity Breaks Intervention |
| Talking Breaks ControlEvery 30 min a researcher will start a brief conversation with a participant based on a pre-selected topic, which will change with each break. Topics are standardized across participants and include, for example, pollution, smart clothes, and hydration. A presentation will be followed by questions and answers. The break will last 3 min. | Behavioural | Talking Breaks Control |
Primary outcome
Neuroelectric measures of inhibitory control - P3 component of event-related potentials (ERPs)
Time frame: Assessed immediately before and after the intervention (on the same day as intervention)
The change in the P3 component measured during the modified flanker task
Neuroelectric measures of inhibitory control - N2 component of event-related potentials (ERPs)
Time frame: Assessed immediately before and after the intervention (on the same day as intervention)
The change in the N2-ERP component measured during the modified flanker task.
Inhibitory control measured with a modified flanker task - accuracy
Time frame: Assessed immediately before and after the intervention (on the same day as intervention)
The change in accuracy on the modified flanker task
Inhibitory control measured with a modified flanker task - reaction time
Time frame: Assessed immediately before and after the intervention (on the same day as intervention)
The change in measures of reaction time on the modified flanker task
Neuroelectric measures of working memory - P3-ERP component
Time frame: Assessed immediately before and after the intervention (on the same day as intervention)
The change in the P3-ERP component during the n-back task.
Working memory measured with an n-back task - accuracy
Time frame: Assessed immediately before and after the intervention (on the same day as intervention)
The change in accuracy on the n-back task
Working memory measured with an n-back task - reaction time
Time frame: Assessed immediately before and after the intervention (on the same day as intervention)
The change in measures of reaction time on the n-back task
4 secondary outcomes
Post-prandial insulin response during an oral glucose tolerance test
Time frame: Assessed during the intervention
Post-prandial glucose response during an oral glucose tolerance test
Time frame: Assessed during the intervention
Matsuda index
Time frame: Assessed during the intervention
Stumvoll metabolic clearance rate (MCR)
Time frame: Assessed during the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- 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.
Dominika M Pindus, PhD principal investigator
University of Illinois at Urbana-Champaign
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity Breaks Intervention in people with Obesity, run by University of Illinois at Urbana-Champaign at 1 site in United States.
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 13 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 7 Feb 2024. 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 United States. 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?
Results are not available in the source record.
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?
Neuroelectric measures of inhibitory control - P3 component of event-related potentials (ERPs) (time frame: Assessed immediately before and after the intervention (on the same day as intervention)). The study lists 7 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 7 Feb 2024.