NCT04645875

Brief Summary

The purpose of this study is to investigate the effects of substituting sitting under free-living conditions in South Asian adults with overweight and obesity on continuous glucose profiles.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

November 19, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

November 19, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 27, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
4.6 years until next milestone

Results Posted

Study results publicly available

March 24, 2026

Completed
Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

8 months

First QC Date

November 19, 2020

Results QC Date

May 30, 2022

Last Update Submit

March 23, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Glycaemia

    Net incremental area under the curve (iAUC), calculated by subtracting waking glucose concentration for each day from the total AUC. Waking hours were identified individually for each participant from activPAL data and then normalised to a 16 h day. Each of these variables was calculated as the mean of valid days within each regimen. A minimum of one valid day that coincided with both FGM and activPAL data was required in each experimental regimen for inclusion in the analysis.

    Mean net incremental area under the curve for waking hours (16 h) interstitial glucose concentration per day for 4 valid days during each intervention

Secondary Outcomes (3)

  • Sitting Time

    Mean total sitting time per day for 4 valid days during each intervention

  • Standing Time

    Mean standing time per day for 4 valid days during each intervention

  • Total Stepping Time

    Mean total stepping time per day for 4 valid days during each intervention

Study Arms (2)

SIT regimen, then SITless regimen

EXPERIMENTAL

Firstly, participants performed the SIT regimen (4 days) where they were instructed to restrict walking to ≤1 h/day and standing to ≤1 h/day during their waking day. Participants were allowed to perform their daily activities, including cooking and other household activities, within the 2-h of permitted walking and standing. After a washout period of 3 days, they then performed the SITless regimen (4 days). SIT regimen: See SIT regimen arm description SITless regimen: See SITless regimen arm description

Other: SIT regimen

SITless regimen, then SIT regimen

EXPERIMENTAL

Firstly, participants performed the SITLess regimen (4 days) where they were instructed to substitute a minimum of 5-h/day sitting with ≥3-h of standing and ≥2-h of self-perceived LPA in addition to interrupting their sitting for 2-5-min every 30-min. A list of activities (including walking at a slow pace, walking on the spot, jumping up and down, and standing) was provided as examples of activities that particpants could perform during this regimen. After a washout period of 3 days, they then performed the SIT regimen (4 days). SITless regimen: See SITless regimen arm description SIT regimen: See SIT regimen arm description

Other: SITless regimen

Interventions

See SIT regimen arm description

SIT regimen, then SITless regimen

See SITless regimen arm description

SITless regimen, then SIT regimen

Eligibility Criteria

Age18 Years - 75 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Self-identified South Asian ethnicity.
  • Self-report sitting at least 7 hours per day.
  • Overweight or obese (BMI\>23.0 kg/m2)

You may not qualify if:

  • Unable to speak and read English.
  • Not able to perform light-intensity activities.
  • Diagnosed cardiovascular disease or diabetes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bedfordshire

Bedford, MK41 9EA, United Kingdom

Location

Related Publications (1)

  • Dey KC, Zakrzewski-Fruer JK, Smith LR, Jones RL, Maylor BD, Yates TE, Bailey DP. Substituting sitting with standing and walking in free-living conditions improves daily glucose concentrations in South Asian adults living with overweight/obesity. Eur J Appl Physiol. 2026 Jan;126(1):579-589. doi: 10.1007/s00421-025-05919-7. Epub 2025 Aug 5.

MeSH Terms

Conditions

Cardiovascular DiseasesDiabetes MellitusDiabetes Mellitus, Type 2Sedentary Behavior

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Results Point of Contact

Title
Dr Kamalesh Dey
Organization
University of Bedfordshire

Study Officials

  • Kamalesh DEY, PhD

    University of Bedfordshire

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Reader in Sedentary Behaviour and Health

Study Record Dates

First Submitted

November 19, 2020

First Posted

November 27, 2020

Study Start

November 19, 2020

Primary Completion

July 31, 2021

Study Completion

July 31, 2021

Last Updated

March 24, 2026

Results First Posted

March 24, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations