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The Effects of Interrupting Prolonged Sitting With Bouts of Physical Activity on Neurocognitive Function in Obesity (SITLess)

Primary Purpose

Obesity

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Physical Activity Breaks Intervention

Talking Breaks Control

About this trial

This is an interventional basic science trial for Obesity focused on measuring Sedentary Behavior, Executive Function, Event Related Potentials, Insulin, Glucose

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

• Informed consent
- Age 21-55 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
- 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

Exclusion Criteria:

• 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
- Participants with anemia
- Pregnant women or those with a possible pregnancy
- History of injury to the spinal cord

Sites / Locations

University of Illinois at Urbana-ChampaignRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Physical Activity Breaks Intervention

Talking Breaks Control

Arm Description

Participants will sit continuously for 3 hours and interrupt their sitting by walking on a treadmill at a moderate intensity for 3 min.

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.

Outcomes

Primary Outcome Measures

Neuroelectric measures of inhibitory control - P3 component of event-related potentials (ERPs)

The difference between experimental and control conditions in the P3 component measured during the modified flanker task

Neuroelectric measures of inhibitory control - N2 component of event-related potentials (ERPs)

The difference between experimental and control conditions in the N2-ERP component measured during the modified flanker task.

Inhibitory control measured with a modified flanker task - accuracy

The difference between experimental and control conditions in accuracy on the modified flanker task

Inhibitory control measured with a modified flanker task - reaction time

The difference between experimental and control conditions in measures of reaction time on the modified flanker task

Neuroelectric measures of working memory - P3-ERP component

The difference between experimental and control conditions in the P3-ERP component during the n-back task.

Working memory measured with an n-back task - accuracy

The difference between experimental and control conditions in accuracy on the n-back task

Working memory measured with an n-back task - reaction time

The difference between experimental and control conditions in measures of reaction time on the n-back task

Secondary Outcome Measures

Post-prandial insulin response during an oral glucose tolerance test

Insulin Area Under the Curve (AUC)

Post-prandial glucose response during an oral glucose tolerance test

Glucose Area Under the Curve (AUC)

Matsuda index

Insulin Sensitivity measured with Matsuda index

Stumvoll metabolic clearance rate (MCR)

Insulin Sensitivity expressed as Stumvoll metabolic clearance rate

Full Information

NCT ID

NCT04926207

First Posted

May 24, 2021

Last Updated

June 6, 2021

Sponsor

University of Illinois at Urbana-Champaign

1. Study Identification

Unique Protocol Identification Number

NCT04926207

Brief Title

The Effects of Interrupting Prolonged Sitting With Bouts of Physical Activity on Neurocognitive Function in Obesity

Acronym

SITLess

Official Title

SIT Less! Interrupting Prolonged Sitting With Brief Physical Activity Bouts to Improve Neurocognitive Function in Adults With Obesity

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Unknown status

Study Start Date

May 3, 2021 (Actual)

Primary Completion Date

May 2, 2022 (Anticipated)

Study Completion Date

May 2, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Illinois at Urbana-Champaign

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity

Keywords

Sedentary Behavior, Executive Function, Event Related Potentials, Insulin, Glucose

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Physical Activity Breaks Intervention

Arm Type

Experimental

Arm Description

Participants will sit continuously for 3 hours and interrupt their sitting by walking on a treadmill at a moderate intensity for 3 min.

Arm Title

Talking Breaks Control

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Physical Activity Breaks Intervention

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Talking Breaks Control

Intervention Description

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.

Primary Outcome Measure Information:

Title

Neuroelectric measures of inhibitory control - P3 component of event-related potentials (ERPs)

Description

The difference between experimental and control conditions in the P3 component measured during the modified flanker task

Time Frame