NCT04926207

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started May 2021

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 3, 2021

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

May 24, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 15, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
Last Updated

February 7, 2024

Status Verified

February 1, 2024

Enrollment Period

3.1 years

First QC Date

May 24, 2021

Last Update Submit

February 5, 2024

Conditions

Keywords

Sedentary BehaviorExecutive FunctionEvent Related PotentialsInsulinGlucose

Outcome Measures

Primary Outcomes (7)

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

    The change in the P3 component measured during the modified flanker task

    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.

    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

    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

    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.

    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

    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

    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

    Assessed during the intervention

  • Post-prandial glucose response during an oral glucose tolerance test

    Assessed during the intervention

  • Matsuda index

    Assessed during the intervention

  • Stumvoll metabolic clearance rate (MCR)

    Assessed during the intervention

Study Arms (2)

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.

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.

Behavioral: Talking Breaks Control

Interventions

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.

Physical Activity Breaks Intervention

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.

Talking Breaks Control

Eligibility Criteria

Age21 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois at Urbana-Champaign

Urbana, Illinois, 61801, United States

Location

MeSH Terms

Conditions

ObesitySedentary BehaviorInsulin Resistance

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehaviorHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Officials

  • Dominika M Pindus, PhD

    University of Illinois at Urbana-Champaign

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2021

First Posted

June 15, 2021

Study Start

May 3, 2021

Primary Completion

May 31, 2024

Study Completion

May 31, 2024

Last Updated

February 7, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations