Trial Outcomes & Findings for Substituting Sitting With Standing and Walking in Free-living Conditions Improves Daily Glucose Profile in South Asians (NCT NCT04645875)

NCT ID: NCT04645875

Last Updated: 2026-03-24

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

18 participants

Primary outcome timeframe

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

Results posted on

2026-03-24

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.

Three days washout period. Exclusion criteria: known heart disease, diabetes, bloodborne diseases (e.g., HIV), liver disease, renal failure, pregnancy, recent or current smoker, taking any glucose or lipid-lowering medication, allergies to the test meals, other health issues (psychological or neurological disorders), and any other injuries that might limit the ability to perform light- intensity exercise.

Participant milestones

Participant milestones
Measure
SIT Regimen, Then SITless Regimen
Firstly, participants perfomed 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). SITless regimen: See SITless regimen arm description
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). SIT regimen: See SIT regimen arm description
First Intervention (4 days)
STARTED
9
9
First Intervention (4 days)
COMPLETED
9
9
First Intervention (4 days)
NOT COMPLETED
0
0
Washout (3 days)
STARTED
9
9
Washout (3 days)
COMPLETED
9
9
Washout (3 days)
NOT COMPLETED
0
0
Second Intervention (4 days)
STARTED
9
9
Second Intervention (4 days)
COMPLETED
7
7
Second Intervention (4 days)
NOT COMPLETED
2
2

Reasons for withdrawal

Reasons for withdrawal
Measure
SIT Regimen, Then SITless Regimen
Firstly, participants perfomed 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). SITless regimen: See SITless regimen arm description
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). SIT regimen: See SIT regimen arm description
Second Intervention (4 days)
Testing positive for COVID-19
2
2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
All Study Participants
n=18 Participants
All participants were randomised to receive all interventions, including the SIT and SITLess regimen. SIT regimen: See SIT regimen arm description SITless regimen: See SITless regimen arm description
Age, Continuous
42.1 years
STANDARD_DEVIATION 12.0 • n=138 Participants
Sex: Female, Male
Female
10 Participants
n=138 Participants
Sex: Female, Male
Male
8 Participants
n=138 Participants
Race/Ethnicity, Customized
South Asian sub-group · Bangladeshi
6 Participants
n=138 Participants
Race/Ethnicity, Customized
South Asian sub-group · Indian
7 Participants
n=138 Participants
Race/Ethnicity, Customized
South Asian sub-group · Pakistani
5 Participants
n=138 Participants
Region of Enrollment
United Kingdom
18 participants
n=138 Participants
Body mass index (BMI)
27.5 kg/m^2
STANDARD_DEVIATION 3.8 • n=138 Participants
Waist circumference (WC)
94.9 cm
STANDARD_DEVIATION 10.9 • n=138 Participants

PRIMARY outcome

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

Population: Overweight/obese South Asians

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.

Outcome measures

Outcome measures
Measure
SIT Regimen
n=14 Participants
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). SITless regimen: See SITLess regimen arm description
SITless Regimen
n=14 Participants
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). SIT regimen: See SIT regimen arm description
Glycaemia
98.5 mmol/L.16 h
Interval 82.7 to 114.4
89.4 mmol/L.16 h
Interval 73.5 to 105.2

SECONDARY outcome

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

Population: Overweight/obese South Asians

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.

Outcome measures

Outcome measures
Measure
SIT Regimen
n=14 Participants
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). SITless regimen: See SITLess regimen arm description
SITless Regimen
n=14 Participants
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). SIT regimen: See SIT regimen arm description
Sitting Time
10.6 h/day
Interval 9.5 to 11.7
7.0 h/day
Interval 5.9 to 8.1

SECONDARY outcome

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

Population: Overweight/obese South Asians

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.

Outcome measures

Outcome measures
Measure
SIT Regimen
n=14 Participants
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). SITless regimen: See SITLess regimen arm description
SITless Regimen
n=14 Participants
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). SIT regimen: See SIT regimen arm description
Standing Time
3.8 h/day
Interval 2.8 to 4.8
5.7 h/day
Interval 4.8 to 6.7

SECONDARY outcome

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

Population: Overweight/obese South Asians

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.

Outcome measures

Outcome measures
Measure
SIT Regimen
n=14 Participants
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). SITless regimen: See SITLess regimen arm description
SITless Regimen
n=14 Participants
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). SIT regimen: See SIT regimen arm description
Total Stepping Time
1.2 h/day
Interval 0.8 to 1.5
2.8 h/day
Interval 2.4 to 3.1

Adverse Events

SIT Regimen

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

SITless Regimen

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Kamalesh Dey

University of Bedfordshire

Phone: 07305192256

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place