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

Substituting Sitting With Standing and Walking in Free-living Conditions Improves Daily Glucose Concentrations in South Asian Adults Living With Overweight/Obesity

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04645875
Enrollment
18
Registered
2020-11-27
Start date
2020-11-19
Completion date
2021-07-31
Last updated
2026-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Cardiovascular Risk Factor, Diabetes, Sedentary Behavior, Sedentary Lifestyle, Type 2 Diabetes

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.

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.

Interventions

OTHERSIT regimen

See SIT regimen arm description

OTHERSITless regimen

See SITless regimen arm description

Sponsors

University of Bedfordshire
Lead SponsorOTHER
Brunel University
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
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

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

Design outcomes

Primary

MeasureTime frameDescription
GlycaemiaMean net incremental area under the curve for waking hours (16 h) interstitial glucose concentration per day for 4 valid days during each interventionNet 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.

Secondary

MeasureTime frameDescription
Sitting TimeMean total sitting time per day for 4 valid days during each interventionTotal 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.
Standing TimeMean standing time per day for 4 valid days during each interventionPhysical 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.
Total Stepping TimeMean total stepping time per day for 4 valid days during each interventionPhysical 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.

Countries

United Kingdom

Contacts

PRINCIPAL_INVESTIGATORKamalesh DEY, PhD

University of Bedfordshire

Participant flow

Recruitment details

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.

Pre-assignment details

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.

Baseline characteristics

Characteristic
Age, Continuous42.1 years
STANDARD_DEVIATION 12
Body mass index (BMI)27.5 kg/m^2
STANDARD_DEVIATION 3.8
Race/Ethnicity, Customized
South Asian sub-group
Bangladeshi
6 Participants
Race/Ethnicity, Customized
South Asian sub-group
Indian
7 Participants
Race/Ethnicity, Customized
South Asian sub-group
Pakistani
5 Participants
Region of Enrollment
United Kingdom
18 participants
Sex: Female, Male
Female
10 Participants
Sex: Female, Male
Male
8 Participants
Waist circumference (WC)94.9 cm
STANDARD_DEVIATION 10.9

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 180 / 18
other
Total, other adverse events
0 / 180 / 18
serious
Total, serious adverse events
0 / 180 / 18

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026