Cardiovascular Risk FactorNCT04645875
Substituting Sitting With Standing and Walking in Free-living Conditions Improves Daily Glucose Profile in South Asians
A study testing SIT regimen and SITless regimen in people with Cardiovascular Risk Factor and Cardiovascular Diseases, run by University of Bedfordshire at 1 site in United Kingdom.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factor, Cardiovascular Diseases, Diabetes
- What is being tested?
- SIT regimen and SITless regimen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Nov 2020to 31 Jul 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Self-identified South Asian ethnicity.
- Self-report sitting at least 7 hours per day.
- Overweight or obese (BMI>23.0 kg/m2)
Who cannot join
- Unable to speak and read English.
- Not able to perform light-intensity activities.
- Diagnosed cardiovascular disease or diabetes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Substituting Sitting With Standing and Walking in Free-living Conditions Improves Daily Glucose Concentrations in South Asian Adults Living With Overweight/Obesity
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.
- Conditions
- Cardiovascular Risk Factor, Cardiovascular Diseases, Diabetes, Type 2 Diabetes, Sedentary Behavior, Sedentary Lifestyle
- Being tested
- SIT regimen, SITless regimen
- Medical subject headings
- Cardiovascular Diseases, Diabetes Mellitus, Diabetes Mellitus, Type 2, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIT regimenOther
See SIT regimen arm description
SITless regimenOther
See SITless regimen arm description
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: SITless regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Mean total sitting time per day for 4 valid days during each intervention
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.
Measured: Mean standing time per day for 4 valid days during each intervention
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.
Measured: Mean total stepping time per day for 4 valid days during each intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2020
- Study start19 Nov 2020
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Risk FactorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bedfordshire
- Sponsor type
- University, hospital or other
- Collaborators
- Brunel University
- Responsible party
- Principal investigator, Dr Daniel Bailey, University of Bedfordshire
- Investigators
- Kamalesh DEY, PhD, Principal investigator, University of Bedfordshire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04645875
- Sponsor's protocol ID
- 2020ISPAR006
- Status last verified
- Mar 2026
- First submitted
- 19 Nov 2020
- Last updated
- 24 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Substituting Sitting With Standing and Walking in Free-living Conditions Improves Daily Glucose Concentrations in South Asian Adults Living With Overweight/Obesity
- ClinicalTrials.gov ID
- NCT04645875
- Acronym / sponsor ID
- 2020ISPAR006
- Conditions
- Cardiovascular Risk Factor, Cardiovascular Diseases, Diabetes, Type 2 Diabetes, Sedentary Behavior, Sedentary Lifestyle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of BedfordshireUniversity, hospital or other
- Collaborators
- Brunel University
- Study start
- 19 Nov 2020 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 27 Nov 2020 (actual)
- Results
- Posted 24 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SIT regimen, then SITless regimen | Experimental | Other: SIT regimenFirstly, 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 |
| SITless regimen, then SIT regimen | Experimental | Other: SITless regimenFirstly, 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Self-identified South Asian ethnicity.
- Self-report sitting at least 7 hours per day.
- Overweight or obese (BMI>23.0 kg/m2)
Key exclusion criteria (3 listed)
- Unable to speak and read English.
- Not able to perform light-intensity activities.
- Diagnosed cardiovascular disease or diabetes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SIT regimenSee SIT regimen arm description | Other | SIT regimen, then SITless regimen |
| SITless regimenSee SITless regimen arm description | Other | SITless regimen, then SIT regimen |
Primary outcome
Glycaemia
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
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.
3 secondary outcomes
Sitting Time
Time frame: Mean total sitting time per day for 4 valid days during each intervention
Standing Time
Time frame: Mean standing time per day for 4 valid days during each intervention
Total Stepping Time
Time frame: Mean total stepping time per day for 4 valid days during each intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40764840Dey 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kamalesh DEY, PhD principal investigator
University of Bedfordshire
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SIT regimen and SITless regimen in people with Cardiovascular Risk Factor and Cardiovascular Diseases, run by University of Bedfordshire at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycaemia (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04645875, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.