NCT06700187

Brief Summary

Rationale: Sedentary behavior (SB) has been associated with impaired cognitive function in elderly, and negatively impacts glucose metabolism. Interrupting sitting with physical activity (PA) bouts may exert beneficial effects on cognitive function via an improved glucose metabolism. Nevertheless, the impact of breaking up prolonged sitting with various frequencies of PA bouts remains unexplored in young sedentary adults. Moreover, we hypothesize that the pattern of the breaks modifies the effects. Thus, randomized controlled trials (RCTs) are highly needed to investigate the effects of interrupting sitting with different frequencies of PA on cognitive function and glucose metabolism. We now hypothesize that interrupting sitting with different frequencies of walking breaks differentially affects cognitive function and glucose metabolism. Objective: The aim is to investigate the effects of breaking up sitting with different frequencies of PA bouts on cognitive function and glucose metabolism in young sedentary adults. Study design: A randomised, controlled cross-over study will be performed, consisting of four interventions in a counterbalanced order: uninterrupted prolonged sitting, short breaks, moderate breaks, and long breaks. Intervention: Participants will complete four conditions in a randomized, counterbalanced order: sitting (uninterrupted prolonged sitting without any interruptions), short breaks (walk 1 minute every 10 minutes), moderate breaks (walk 3 minutes every 30 minutes), and long breaks (walk 27 minutes during the intervention). Each condition lasts 4.5 hours.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 3, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 12, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 21, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2026

Completed
Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

1.5 years

First QC Date

November 12, 2024

Last Update Submit

January 12, 2026

Conditions

Keywords

Sedentary behaviorsitting interruptionscognitionglucose metabolism

Outcome Measures

Primary Outcomes (1)

  • Mental flexibility

    It will be assessed using the computer-based Trial Making Test

    baseline and 5 hours post baseline

Secondary Outcomes (9)

  • Interference

    baseline and 5 hours post baseline

  • Memory

    baseline and 5 hours post baseline

  • Attention

    baseline and 5 hours post baseline

  • Glucose metabolism

    baseline, 30 minutes, 1 hour, 1.5 hour, 2 hour, 3 hour, 4 hour, and 5 hour post baseline

  • Glucose metabolism

    baseline, 30 minutes, 1 hour, 1.5 hour, 2 hour, 3 hour, 4 hour, and 5 hour post baseline

  • +4 more secondary outcomes

Study Arms (2)

Interrupting sitting

EXPERIMENTAL

Participants will engage in low-intensity walking breaks in different frequencies for 4.5 hours

Other: Interrupting sitting with walking breaks

Control

NO INTERVENTION

Paticipants will remain seated for 4.5 hours

Interventions

Participants will engage in 27 minutes walking in different frequencies, including short breaks (walk 1 minute every 10 minutes), moderate breaks (walk 3 minutes every 30 minutes), and long breaks (walk 27 minutes in one time during the intervention).

Interrupting sitting

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Men and women aged 18-35 years;
  • BMI between 18.5-24.9 kg/m2;
  • SB, i.e. sitting for an average of at least 9 hours per day;
  • Physically inactive, i.e. engaging in exercise for less than 2 to 3 times per week;
  • Stable body weight (weight gain or loss \< 3 kg in the past three months);
  • Willingness to engage in four 6-hour laboratory visits;
  • No difficult cannulation.

You may not qualify if:

  • Not sedentary, i.e. sitting for less than an average of 9 hours per day;
  • Physically active, i.e. engaging in exercise for more than 3 times a week;
  • Abuse of drugs;
  • Use medication to treat BP, lipid, or glucose metabolism;
  • Pregnant females.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nutrition and movement science

Maastricht, Netherlands

RECRUITING

Related Publications (5)

  • Wheeler MJ, Green DJ, Cerin E, Ellis KA, Heinonen I, Lewis J, Naylor LH, Cohen N, Larsen R, Dempsey PC, Kingwell BA, Owen N, Dunstan DW. Combined effects of continuous exercise and intermittent active interruptions to prolonged sitting on postprandial glucose, insulin, and triglycerides in adults with obesity: a randomized crossover trial. Int J Behav Nutr Phys Act. 2020 Dec 14;17(1):152. doi: 10.1186/s12966-020-01057-9.

    PMID: 33308235BACKGROUND
  • Homer AR, Taylor FC, Dempsey PC, Wheeler MJ, Sethi P, Townsend MK, Grace MS, Green DJ, Cohen ND, Larsen RN, Kingwell BA, Owen N, Dunstan DW. Frequency of Interruptions to Sitting Time: Benefits for Postprandial Metabolism in Type 2 Diabetes. Diabetes Care. 2021 Jun;44(6):1254-1263. doi: 10.2337/dc20-1410. Epub 2021 Apr 26.

    PMID: 33905343BACKGROUND
  • Duran AT, Friel CP, Serafini MA, Ensari I, Cheung YK, Diaz KM. Breaking Up Prolonged Sitting to Improve Cardiometabolic Risk: Dose-Response Analysis of a Randomized Crossover Trial. Med Sci Sports Exerc. 2023 May 1;55(5):847-855. doi: 10.1249/MSS.0000000000003109. Epub 2023 Jan 12.

    PMID: 36728338BACKGROUND
  • Wheeler MJ, Green DJ, Ellis KA, Cerin E, Heinonen I, Naylor LH, Larsen R, Wennberg P, Boraxbekk CJ, Lewis J, Eikelis N, Lautenschlager NT, Kingwell BA, Lambert G, Owen N, Dunstan DW. Distinct effects of acute exercise and breaks in sitting on working memory and executive function in older adults: a three-arm, randomised cross-over trial to evaluate the effects of exercise with and without breaks in sitting on cognition. Br J Sports Med. 2020 Jul;54(13):776-781. doi: 10.1136/bjsports-2018-100168. Epub 2019 Apr 29.

    PMID: 31036563BACKGROUND
  • Wu Y, Van Gerven PWM, de Groot RHM, Eijnde BO, Winkens B, Savelberg HHCM. Effects of breaking up sitting with light-intensity physical activity on cognition and mood in university students. Scand J Med Sci Sports. 2023 Mar;33(3):257-266. doi: 10.1111/sms.14277. Epub 2022 Dec 1.

    PMID: 36434768BACKGROUND

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

November 12, 2024

First Posted

November 21, 2024

Study Start

October 3, 2024

Primary Completion

March 27, 2026

Study Completion

March 27, 2026

Last Updated

January 14, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

Individuals wanting access to IPD should contact the principal investigator (hans.savelberg@maastrichtuniversity.nl)

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Starting after 6 months of publication
Access Criteria
Available to all researchers interested in interrupting sitting studies

Locations