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CompletedNCT04645875Updated Mar 24, 2026Results posted

Substituting Sitting With Standing and Walking in Free-living Conditions Improves Daily Glucose Profile in South Asians

An interventional study of SIT regimen and SITless regimen in Cardiovascular Risk Factor, Cardiovascular Diseases and Diabetes, sponsored by University of Bedfordshire. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-24.

Sponsored by University of Bedfordshire · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the detailed description

Anthropometric measurement tools, including a stadiometer, a measurement tape and a digital weighing scale, an activity monitor and a Flash Glucose Monitor and sensor, were posted to the participants' home or workplace or the research team dropped all these items at participants' doorstep to allow participants to take their measures including height, weight, and waist circumference.

Participants performed a try-out day of the SITless regimen after preliminary testing and before the first experimental regimen. Participants were only eligible for inclusion if they were able to adhere to the experimental protocol (i.e., substitute a minimum of 5-h/day sitting with ≥2-h of self-perceived light walking and ≥3-h of standing), assessed via monitoring with an activPAL. Participants were provided with a second attempt if required.

After the try-out day, participants were set up with the FGM and activPAL, which were both worn throughout the experimental period. Setup was completed 24-h before the commencement of the first experimental regimen and subsequently worn for 11 days (i.e., 2* 4-day regimens and 3 days washout). Regimen 1 (SIT or SITless) took place over 4 days (day 1-4: Monday to Thursday), followed by a 3-day washout period (day 5-7: Friday to Sunday), followed by regimen 2 (SIT or SITless) for 4 days (day 8-11: Monday to Thursday). Participants were informed of the order of their experimental regimens and provided verbal and written guidance on how to complete the protocols. The experimental regimens were as follows:

  • SIT regimen: Participants 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.
  • SITless regimen: Participants 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 participants could perform during this regimen. Participants received feedback on their non-sitting time and the number of light and moderate-intensity steps from the try-out day. They were guided towards achieving compliance in this regimen by identifying potential activities they could engage in to interrupt sitting, reviewing their number of sitting interruptions and aiming to accumulate approximately 12,000 steps per day (6,000 steps being equivalent to 1-h of moderate-intensity walking).

Participants were asked to refrain from food and drink containing alcohol for 24-h before and to avoid performing structured exercise for 48-h before the experimental protocol commenced and throughout the entire experimental period (a total of 11-days). A kitchen scale was provided so participants could weigh and record all food and beverage consumption in a diary during the first 4-day regimen and replicate this dietary intake exactly during the second 4-day regimen. Participants were instructed to consume a standardised diet (at least 50% carbohydrate) in order to reduce dietary heterogeneity within the study population. Participants were advised that the meals were spaced evenly throughout the day with 3 to 4-h intervals, with snacks consumed between meals to ensure three distinct and consistent glucose responses across each day.

02

Conditions studied

  • Cardiovascular Risk Factor
  • Cardiovascular Diseases
  • Diabetes
  • Type 2 Diabetes
  • Sedentary Behavior
  • Sedentary Lifestyle
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Unable to speak and read English.
  • Not able to perform light-intensity activities.
  • Diagnosed cardiovascular disease or diabetes.
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
18 participants (actual)

Study arms

  • Experimental
    SIT regimen, then SITless regimen

    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

  • Experimental
    SITless regimen, then SIT regimen

    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

  • OtherSIT regimen

    See SIT regimen arm description

  • OtherSITless regimen

    See SITless regimen arm description

05

What researchers measure

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.

    Time frame: 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

  1. Sitting Time

    Total sitting time was measured 24 h/day during each activity regimen using an activPAL3 activity monitor. ActivPAL3 data were processed using ProcessingPAL software. After an automated estimate of valid data using the valid wear criteria, ProcessingPAL summary outputs variables were produced in a Microsoft Excel sheet. 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.

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

  2. Standing Time

    Physical activity patterns was measured 24 h/day during each activity regimen using an activPAL3 activity monitor. ActivPAL3 data was processed using ProcessingPAL software. After an automated estimate of valid data using the valid wear criteria, ProcessingPAL summary outputs variables were produced in a Microsoft Excel sheet. 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.

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

  3. Total Stepping Time

    Physical activity patterns were measured 24 h/day during each activity regimen using an activPAL3 activity monitor. ActivPAL3 data were processed using ProcessingPAL software. After an automated estimate of valid data using the valid wear criteria, ProcessingPAL summary outputs variables were produced in a Microsoft Excel sheet. 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.

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

06

Results

Posted Mar 24, 2026

Participant flow

A total of 18 Overweight/obese South Asians (BMI\>23.0 kg/m\^2) aged between 18 and 75 years and able to walk were recruited; data collection was performed between November 2020 and July 2021.

First Intervention (4 days)
Participant flow — First Intervention (4 days)
MilestoneSIT Regimen, Then SITless RegimenSITless Regimen, Then SIT Regimen
Started99
Completed99
Not completed00
Washout (3 days)
Participant flow — Washout (3 days)
MilestoneSIT Regimen, Then SITless RegimenSITless Regimen, Then SIT Regimen
Started99
Completed99
Not completed00
Second Intervention (4 days)
Participant flow — Second Intervention (4 days)
MilestoneSIT Regimen, Then SITless RegimenSITless Regimen, Then SIT Regimen
Started99
Completed77
Not completed22
Withdrew: Testing positive for covid-1922

Outcome measures

PrimaryGlycaemia

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.

Time frame:
Mean net incremental area under the curve for waking hours (16 h) interstitial glucose concentration per day for 4 valid days during each intervention
Reported as:
Mean · mmol/L.16 h
Glycaemia
mmol/L.16 hSIT RegimenSITless Regimen
Glycaemia98.5 (82.7 to 114.4)89.4 (73.5 to 105.2)
SecondarySitting Time

Total sitting time was measured 24 h/day during each activity regimen using an activPAL3 activity monitor. ActivPAL3 data were processed using ProcessingPAL software. After an automated estimate of valid data using the valid wear criteria, ProcessingPAL summary outputs variables were produced in a Microsoft Excel sheet. 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.

Time frame:
Mean total sitting time per day for 4 valid days during each intervention
Reported as:
Mean · h/day
Sitting Time
h/daySIT RegimenSITless Regimen
Sitting Time10.6 (9.5 to 11.7)7.0 (5.9 to 8.1)
SecondaryStanding Time

Physical activity patterns was measured 24 h/day during each activity regimen using an activPAL3 activity monitor. ActivPAL3 data was processed using ProcessingPAL software. After an automated estimate of valid data using the valid wear criteria, ProcessingPAL summary outputs variables were produced in a Microsoft Excel sheet. 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.

Time frame:
Mean standing time per day for 4 valid days during each intervention
Reported as:
Mean · h/day
Standing Time
h/daySIT RegimenSITless Regimen
Standing Time3.8 (2.8 to 4.8)5.7 (4.8 to 6.7)
SecondaryTotal Stepping Time

Physical activity patterns were measured 24 h/day during each activity regimen using an activPAL3 activity monitor. ActivPAL3 data were processed using ProcessingPAL software. After an automated estimate of valid data using the valid wear criteria, ProcessingPAL summary outputs variables were produced in a Microsoft Excel sheet. 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.

Time frame:
Mean total stepping time per day for 4 valid days during each intervention
Reported as:
Mean · h/day
Total Stepping Time
h/daySIT RegimenSITless Regimen
Total Stepping Time1.2 (0.8 to 1.5)2.8 (2.4 to 3.1)

Adverse events

Collected over Adverse event data were collected during the data collection period for each participant, which was 11 days.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
SIT Regimen0/18 (0%)0/18 (0%)0/18 (0%)
SITless Regimen0/18 (0%)0/18 (0%)0/18 (0%)

Baseline characteristics

18 Overweight/obese South Asians

Age, Continuous
Age, Continuous(years)All Study Participants
Mean42.1 ± 12.0
Sex: Female, Male
Sex: Female, Male(Participants)All Study Participants
Female10
Male8
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)All Study Participants
South Asian sub-group — Bangladeshi6
South Asian sub-group — Indian7
South Asian sub-group — Pakistani5
Region of Enrollment
Region of Enrollment(participants)All Study Participants
United Kingdom18
Body mass index (BMI)
Body mass index (BMI)(kg/m^2)All Study Participants
Mean27.5 ± 3.8
Waist circumference (WC)
Waist circumference (WC)(cm)All Study Participants
Mean94.9 ± 10.9
07

Study locations

1 site
  • University of Bedfordshire
    Bedford, MK41 9EA, United Kingdom
08

References and documents

Publications

  • 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. PubMed 40764840 ↗

Study documents

  • Protocol and statistical analysis plan · Jun 24, 2020
  • Informed consent form · Jun 24, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT04645875
Lead sponsor
University of Bedfordshire
Collaborators
Brunel University
Responsible party
Dr Daniel Bailey (Reader in Sedentary Behaviour and Health, University of Bedfordshire) — Principal investigator
First posted
Nov 27, 2020
Start date
Nov 19, 2020
Primary completion
Jul 31, 2021
Completion
Jul 31, 2021
Results posted
Mar 24, 2026
Last update
Mar 24, 2026

Study contacts

Kamalesh DEY, PhD
principal investigator · University of Bedfordshire

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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